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Background and aims: Despite the high prevalence and negative effects of hazardous substance use, few young adults enter treatment. Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, has proved efficacious in promoting treatment entry. The aim of the current trial was to compare the efficacy of CRAFT with an active control for parents of young adults (aged 18–24 years) with hazardous substance use. Design: This was a randomized controlled superiority trial comparing CRAFT (n = 58) with an active control group receiving manualized counselling (n = 55), with outcome assessments at 6, 12 and 24 weeks (primary end‐point). A sequential design with a stopping rule was added post recruitment commencement. Setting: The study took place in two outpatient clinics for young adults in Stockholm, Sweden, and subsequently via video‐conference due to COVID‐19. Participants: Between October 2018 and May 2021, 113 participants (92% female) who were parents of young adults (87% male) were recruited. Recruitment was discontinued when 70% of the planned sample had been recruited, following an interim analysis of the primary outcome showing no difference between conditions. Intervention and comparator: Participants were randomized (ratio 1 : 1) to eight manual‐based individual CRAFT sessions or five individual manual‐based counselling sessions + one voluntary psychoeducative group session, delivered over maximum 14 weeks. Measurements The primary outcome measure was the rate of young adult entry in substance use treatment during the trial period (24 weeks). Findings At the 24 weeks follow‐up, 19 (33%) of CRAFT participants and 17 (31%) of counselling participants had reported young adult treatment entry, with no difference between conditions (odds ratio CRAFT versus counselling 0.84, 95% confidence interval = 0.35; 1.99, P = 0.700). Both conditions reported clinically relevant reductions in young adult substance use, but no change in participants' levels of depression, anxiety or stress. Conclusions: This trial showed no statistically significant evidence that Community Reinforcement and Family Training (CRAFT), a support programme for concerned significant others of people with substance use disorders, is more efficacious than manual‐based counselling regarding treatment entry for young adults. [ABSTRACT FROM AUTHOR]

Background and aims: Controlled drinking (CD) is an attractive treatment goal for a large proportion of individuals with alcohol use disorder (AUD), but the availability of treatment methods supporting a goal of CD is scarce. We tested if behavioural self‐control training (BSCT) was superior to motivational enhancement therapy (MET) for individuals with AUD with a treatment goal of CD. Design: Randomized controlled two‐group trial. Follow‐ups were conducted at 12 and 26 weeks (primary end‐point) after inclusion. Setting: Three specialized dependency care clinics in Stockholm, Sweden. Participants: Two hundred and fifty self‐referred adults (52% men) fulfilling criteria of AUD (DSM‐5) and a stated treatment goal of CD. Intervention and comparator: BSCT (n = 125), a five‐session treatment based on cognitive behavioural therapy versus the active comparator, MET (n = 125), containing four sessions based on Motivational Interviewing. Measurements Primary outcome measure was mean weekly alcohol consumption at the 26‐week follow‐up, adjusted for baseline consumption. Conclusions: A randomized controlled trial found no evidence of a difference between behavioural self‐control training and motivational enhancement therapy in reducing weekly alcohol consumption. Both groups substantially reduced consumption and behavioural self‐control training was superior in reducing hazardous drinking. [ABSTRACT FROM AUTHOR]

Background and Aims: There is little RCT evidence that brief interventions improve treatment seeking in individuals with severe alcohol use disorder (AUD) or treatment seeking reduces alcohol use. The aim was to test the efficacy of a brief intervention to increase treatment seeking in treatment naïve adults with severe AUD and measure its effects on alcohol use. Design: Parallel group, non‐pharmacologic RCT with intervention (n = 197) and active control (n = 203) conditions, with blinded assessors conducting follow‐ups at 1, 3 and 6 months. Setting: Online recruitment in a 17‐county region of upstate New York, USA. Participants: Inclusion criteria consisted of ages ≥18 years, Alcohol Use Disorders Identification Test score ≥16, exceeds recommended limits for alcohol use and no history of AUD treatment. n = 400; 50% female; 79% white; mean age, 40.7; mean education, 14.6 years. Intervention and comparator: One‐session telephone‐delivered interventions: Cognitive‐Behavioral Therapy for Treatment Seeking (CBT‐TS; intervention), review of a National Institute on Alcohol Abuse and Alcoholism pamphlet on AUD treatment (control). Measurements Self‐report of any AUD treatment use over 3 months (primary outcome) and two standard measures of alcohol use over 6 months (secondary outcomes). Findings Intent‐to‐treat analyses were used. Assessment follow‐up rates were ≥93%. Any alcohol‐related treatment use over 3‐month follow‐up was obtained by 38 (19%) intervention participants and 36 (18%) control participants, a non‐significant difference, χ2 [1] = 0.16, P = 0.689. Secondary analysis showed a significant interaction term between sex and intervention assignment (β = −1.197, P = 0.027). The interaction suggested CBT‐TS was effective in men (22% vs 13%), although the evidence was somewhat weak (P = 0.071), and it was not effective in women (17% vs 24%). Conclusions: A one‐session cognitive‐behavioral therapy intervention to increase treatment seeking in treatment naïve adults with severe alcohol use disorder did not increase treatment seeking. [ABSTRACT FROM AUTHOR]

Aims: To test the effectiveness of a digital intervention to reduce cannabis use (ICan) with adherence‐focused guidance compared with educational cannabis information. Design: This was a single‐blind randomized controlled trial. Follow‐up clinical outcome measurements took place 3 and 6 months after randomization. Setting: The trial was conducted in the Netherlands. The intervention and guidance took place on‐line, with recruitment via Facebook/Instagram advertisement campaigns. Participants: Inclusion criteria were ≥ 18 years, cannabis use on ≥ 3 days/week, the desire to reduce/quit cannabis and using a smartphone. Participants were allocated to either ICan (n = 188) or control (n = 190) (69% male, mean age = 27.5 years). Intervention and comparator: ICan is a mobile (web‐)application based on motivational interviewing and cognitive behavioural therapy and includes three main components: screening, brief intervention (six modules) and referral to treatment. The control condition consisted of non‐interactive educational cannabis information. Measurements Primary outcome was the number of cannabis use days in the 7 days prior to the 6‐month follow‐up measurement. Secondary outcome measures at 3‐ and 6‐month follow‐up were the number of grams of cannabis used and attitudes towards seeking professional help for cannabis use related problems. Findings Intention‐to‐treat analysis showed that 6 months after randomization the mean number of cannabis use days in the past 7 days was reduced in both conditions (time P < 0.001), with no significant group × time interaction effect [ICan = 4.17 days, control = 4.31 days, Cohen's dbetween = 0.06, 95% confidence interval (CI) = −0.15, 0.26, P = 0.93]. Three months after randomization the mean number of grams used in the past 7 days was reduced in both conditions, with a significantly larger reduction in the ICan condition (P = 0.009, Cohen's dbetween = 0.15). At 6‐month follow‐up the significant group × time interaction effect was no longer present (P = 0.30). In both conditions, attitudes towards seeking professional help remained virtually unchanged over time. Conclusions: A digital intervention to reduce cannabis use (ICan) was more effective than non‐interactive educational cannabis information in reducing grams of cannabis used over 3 months, but not more effective at reducing cannabis use days at 6‐month follow‐up. Cannabis use reductions were maintained in both conditions between 3 and 6 months' follow‐up. [ABSTRACT FROM AUTHOR]

Background and Aims: Most alcohol‐dependent people have a moderate level of dependence. General practitioners (GPs) hesitate to engage in this area, and need to have access to treatment they find applicable and feasible to use. The aim of this present study was to test if an open‐ended internet‐based cognitive–behavioral therapy (iCBT) program added to treatment‐as‐usual (TAU) is more effective than TAU‐only for alcohol‐dependent patients in primary care. Design, Setting and Participants: The present study was a two‐group, parallel, randomized controlled superiority trial comparing iCBT+TAU versus TAU‐only at 3‐ and 12‐month follow‐ups. TAU was delivered at 14 primary care centers in Stockholm, Sweden. A total of 264 patients (mean age 51 years, of whom 148 were female and 116 were male) with alcohol dependence and hazardous alcohol consumption were enrolled between September 2017 and November 2019. Measurements: Participants were randomized at a ratio of 1:1 to iCBT, as a self‐help intervention added to TAU (n = 132) or to TAU‐only (n = 132). The GPs gave participants in both treatment arms feedback on the assessments and biomarkers and offered TAU at the primary care center. Primary outcome was weekly alcohol consumption in g/week at 12‐month follow‐up, analyzed according to intention‐to‐treat (n = 132 + 132). The per‐protocol analysis included participants who completed at least one module of iCBT (n = 102 + 132). Findings There was no significant difference in weekly alcohol consumption between iCBT+TAU and TAU in the intention‐to‐treat (ITT) analysis at 12‐month follow‐up [iCBT+TAU = 133.56 (95% confidence interval, CI = 100.94–166.19) and TAU = 176.20 (95% CI = 144.04–208.35), P = 0.068, d = 0.23]. In the per‐protocol analysis, including only those who initiated iCBT, the iCBT+TAU group showed lower mean weekly alcohol consumption compared with TAU [iCBT+TAU = 107.46 (95% CI = 71.17–143.74), TAU = 176.00 (95% CI = 144.21–207.80), P = 0.010, d = 0.42]. Conclusions: In Sweden, an internet‐based cognitive–behavioral program added to treatment‐as‐usual to reduce alcohol consumption showed weak evidence of a benefit at 12 months in the intention‐to‐treat analysis and good evidence of a benefit in the per‐protocol analysis. [ABSTRACT FROM AUTHOR]

Background and Aims: Screening and brief interventions (SBI) in primary health‐care practices (PHCP) are effective in reducing reported alcohol consumption, but have not been routinely implemented. Most programs seeking to improve implementation rates have lacked a theoretical rationale. This study aimed to test whether a theory‐based intervention for PHCPs could significantly increase alcohol SBI delivery. Design Two‐arm, cluster‐randomized controlled, parallel, 12‐month follow‐up, trial. Setting: PHCPs in Portugal. Participants: Staff from 12 PHCPs (n = 222, 81.1% women): nurses (35.6%), general practitioners (28.8%), receptionists (26.1%) and family medicine residents (9.5%); patients screened for alcohol use: intervention n = 8062; controls n = 58. Intervention and Comparator: PHCPs were randomized to receive a training and support program (n = 6; 110 participants) tailored to the barriers and facilitators for implementing alcohol SBIs following the principles of the Behavior Change Wheel/Theoretical Domains Framework approach, or to a waiting‐list control (n = 6; 112 participants). Training was delivered over the first 12 weeks of the trial. Measurements The primary outcome was the proportion of eligible patients screened (unit of analysis: patient list). Secondary outcomes included the brief intervention (BI) rate per screen‐positive patient and the population‐based BI rate (unit of analysis: patient list), and changes in health providers' perceptions of barriers to implementation and alcohol‐related knowledge (unit of analysis: health provider). Findings The implementation program had a significant effect on the screening activity in the intervention practices compared with control practices at the 12‐month follow‐up (21.7% vs. 0.16%, intention‐to‐treat analysis, p = 0.003). Although no significant difference was found on the BI rate per screen‐positive patient (intervention 85.7% vs. control 63.6%, p = 0.55, Bayes factor = 0.28), the intervention was effective in increasing the population‐based BI rate (intervention 0.69% vs. control 0.02%, p = 0.006). Health providers in the intervention arm reported fewer barriers to SBI implementation and higher levels of alcohol‐related knowledge at 12‐month follow‐up than those in control practices. Conclusion: A theory‐based implementation program, which included training and support activities, significantly increased alcohol screening and population‐based brief intervention rates in primary care. [ABSTRACT FROM AUTHOR]

Aims: To test whether the Stop‐tabac smartphone application (app) increased smoking cessation rates. Design A two‐arm, parallel‐group, individually randomized, double‐blind, controlled trial. Setting and Participants: A total of 5293 daily smokers (Stop‐tabac = 2639, control = 2654) enrolled on app stores and on the internet in 2019–20, who lived in France or Switzerland. Intervention and comparator: The Stop‐tabac application includes immediate feedback during episodes of craving and withdrawal; individually tailored counseling messages with notifications sent during 6 months; a discussion forum; fact sheets; modules on nicotine replacement therapy and e‐cigarettes; and calculators of cigarettes not smoked, money saved and days of life gained since quitting. The control application included five brief pages and calculators as above. Measurements Primary outcome: self‐reported smoking cessation after 6 months (no puff of tobacco in the past 4 weeks), with non‐responders counted as smokers. Secondary outcome: self‐reported use of nicotine medications. Findings Participants were aged 36 years on average; 66% were women who smoked 15 cigarettes/day, and 64% screened positive for depression. Stop‐tabac participants used the app over a longer period than control participants (23 versus 11 days, P < 0.001). Smoking cessation rates after 6 months were 9.9% in the Stop‐tabac group versus 10.3% in the control group (odds ratio = 0.96, 95% confidence interval = 0.80–1.45, P = 0.63). Rates of use of nicotine medications after entry in the study were 38 versus 30% after 6 months (χ2 = 8.3, P = 0.004) in the Stop‐tabac and control groups. After 6 months, 26% of participants in the Stop‐tabac group and 8% in the control group said that the app helped them 'a lot' or 'enormously' to quit smoking (χ2 = 113, P < 0.001). Conclusions: In smokers enrolled on the app stores and the internet, allocation to the Stop‐tabac smoking cessation app did not increase smoking cessation rates, but increased rates of use of nicotine medications. [ABSTRACT FROM AUTHOR]

Background and Aims: Alcohol consumption is increasing among older adults. Rethink My Drink is a brief internet-delivered intervention to reduce alcohol consumption and related harms, adapted specifically for older adults. This protocol for a large-scale randomised controlled trial will evaluate whether Rethink My Drink is effective in reducing alcohol consumption and cognitive decline in a sample of older risky drinkers, compared with an active control. Design: 1:1 parallel group, randomised controlled trial. Setting: Online trial in Australia. Participants: Hazardous or harmful drinkers (defined as those scoring =5 on the Alcohol Use Disorders Identification Test [AUDIT]) age 60 to 75 years old (n = 842). Participants will be recruited from August 2021 to August 2022 through online social media advertisements and community networks. Intervention and Comparator: Participants will be randomly allocated to receive access to Rethink My Drink (intervention) or Alcohol: The Facts (comparator), an online patient information booklet provided by New South Wales (NSW) Health. Measurements: Primary outcomes include (i) average weekly standard drinks and (ii) rate of cognitive decline. Secondary outcomes include (i) typical quantity of drinks per drinking day; (ii) heavy episodic drinking; (iii) age-specific risky drinking; (iv) alcoholrelated harms; (v) subjective cognitive complaints; and (vi) quality of life. All primary and secondary outcomes will be assessed at baseline, post-intervention (4 weeks) and 12 months. Effectiveness will be evaluated using multilevel linear regression, adjusting for baseline demographic differences. Bonferroni adjustments will be used to control for multiple comparisons. Multiple imputation, regression weighting and sensitivity analyses will assess the effect of attrition. Comments: This will be the first large-scale trial, internationally, to examine whether a brief internet-delivered intervention is effective in reducing alcohol consumption and cognitive decline among older adults. If successful, the intervention will provide an accessible and highly scalable treatment to reduce risky alcohol consumption in older adulthood. [ABSTRACT FROM AUTHOR]

Background and aims: The majority of smokers accessing the current best treatments continue to smoke. We aimed to test if e‐cigarettes (EC) compared with nicotine replacement treatment (NRT) can help such smokers to reduce smoking. Design Randomized controlled trial of EC (n = 68) versus NRT (n = 67) with 6‐month follow‐up. Setting: Stop smoking service in London, UK. Participants: A total of 135 smokers (median age = 40 years, 51% male) previously unable to stop smoking with conventional treatments. Interventions: Participants received either NRT of their choice (8‐week supply) or an EC starter pack and instructions to purchase further e‐liquids of strength and flavours of their choice themselves. Products were accompanied by minimal behavioural support. Measurements Participants who reported that they stopped smoking or reduced their daily cigarette consumption by at least 50% at 6‐month follow‐up were invited to provide a carbon monoxide (CO) reading. The primary outcome was biochemically validated reduction in smoke intake of at least 50% at 6 months and the main secondary outcome was sustained validated abstinence at 6 months. Drop‐outs were included as 'non‐reducers'. Findings Validated smoking reduction (including cessation) was achieved by 26.5 versus 6.0% of participants in the EC and NRT study arms, respectively [relative risk (RR) = 4.4, P = 0.005, 95% confidence interval (CI) = 1.6–12.4]. Sustained validated abstinence rates at 6 months were 19.1 versus 3.0% (RR = 6.4, P = 0.01, 95% CI = 1.5–27.3). Product use was high and equal in both study arms initially, but at 6 months allocated product use was 47% in the EC arm versus 10% in the NRT arm (χ2(1) = 22.0, P < 0.001), respectively. Adverse events were minor and infrequent. Conclusions: In smokers unable to quit using conventional methods, e‐cigarettes were more effective than nicotine replacement therapy in facilitating validated long‐term smoking reduction and smoking cessation when limited other support was provided. [ABSTRACT FROM AUTHOR]

Aims: To assess the effectiveness of training stop smoking services providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) standard treatment programme compared with usual care. Design Two‐arm cluster‐randomized controlled effectiveness trial across 19 sites with follow‐up at 4‐week, 3‐month, and 6‐month. Setting: Stop smoking services operating in public hospitals in Malaysia. Participants: Five hundred and two smokers [mean ± standard deviation (SD), age 45.6 (13.4) years; 97.4% male] attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition. Intervention and comparator: The intervention consisted of training stop‐smoking practitioners to deliver support and follow‐up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow‐up). Measurements: The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired‐air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO‐verified tobacco smoking abstinence up to 4 weeks and 3 months. Results: Follow‐up rates at 4 weeks, 3 months and 6 months were 80.0, 70.6 and 53.3%, respectively, in the intervention group and 48.8, 30.8 and 23.3%, respectively, in the control group. At 6‐month follow‐up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2 versus 11.0% in an intention‐to‐treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8 versus 47.5% in a follow‐up‐only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04, (95% confidence interval (CI) = 1.22–20.77, P = 0.025) and 1.70, (95% CI = 0.25–11.53, P = 0.589) in the ITT and FUO analyses, respectively. Abstinence rates at 4 week and 3 month follow‐ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis. Conclusions: On an intention‐to‐treat analysis with missing‐equals‐smoking imputation, training Malaysian stop smoking service providers in the UK National Centre for Smoking Cessation and Training standard treatment programme appeared to increase 6 month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow‐up rates. [ABSTRACT FROM AUTHOR]

Aims: The study aimed to evaluate the effectiveness of the government school‐based program #Tamojunto2.0, the third Brazilian version of the European drug prevention program, Unplugged, in preventing the use of alcohol and other drugs. Design A parallel, two‐arm cluster randomized controlled trial was conducted in 205 classes in 73 public schools (37 intervention and 36 control) with a baseline assessment and follow‐up after 9 months. Setting: Schools in the cities of São Paulo, Fortaleza and Eusebio in Brazil. Participants: A total of 5208 students in the 8th grade with a mean age of 13.2 years (standard deviation = 0.8 years) and an equal gender ratio. Intervention: In 2019, the intervention group attended 12 classes of the program #Tamojunto2.0, under the supervision of a team from the Ministry of Health. The control group did not receive any intervention to prevent alcohol and drug use. Measurements The primary outcome measured was prevalence of binge drinking (five or more doses of alcohol in an occasion) within the past month. Secondary outcomes were prevalence of initiation and use of alcohol, tobacco, inhalants, marijuana and cocaine within the past month. Findings A statistically significant difference was not found in the prevalence of binge drinking within the past month between intervention and control groups [odds ratio (OR) = 0.934; 95% confidence interval (CI) = 0.761–1.146]. However, students who were exposed to the program were less likely to initiate alcohol use than those in the control group (OR = 0.782; 95% CI = 0.636–0.961). The Bayes factor for reduction in binge drinking was 0.01, providing evidence in favor of the null hypothesis for this variable. Conclusions: The drug prevention program #Tamojunto 2.0 reduced alcohol initiation, but appeared not to reduce past‐month binge drinking among 8th grade students in Brazil. [ABSTRACT FROM AUTHOR]

Background and aims: Since its first release in 2011, WeChat (Chinese pinyin: Wei Xin) has been widely used to promote health. As the most popular all‐in‐one social media application providing free instant messaging, voice, text, pictures, videos and location information exchange via smartphone, WeChat holds promise for delivering smoking cessation services to a large number of people at low unit cost in China, a country with more than 300 million smokers. This protocol is for a study that aims to assess the efficacy of a WeChat‐based smoking cessation intervention ('WeChat WeQuit') for treatment‐seeking smokers in China. Design In this two‐arm randomized controlled trial (RCT), the control group will receive only a digital version of a booklet of 'Happy Quit'. The intervention group will also receive the 2 weeks pre‐ and 12 weeks post‐quit 'WeChat WeQuit' intervention. Both groups will be followed‐up to 26 weeks (6 months) after quit day. Setting: This on‐line trial has no restrictions on setting or location. Participants: Chinese‐speaking current smokers (have smoked ≥100 cigarettes in their life‐time and currently smoke cigarettes) aged 18+ years willing to make a quit attempt within 1 month (n = 2000) will be recruited by on‐ and off‐line advertising. Potential participants will register their interest by sending WeChat messages or text messages, or making a voice call. Measurements The primary outcome measure is self‐reported 26‐week continuous smoking abstinence with biological verification [test by clinic visit: expired carbon monoxide concentration <10 parts per million (p.p.m.) or by mailing cotinine urine dipsticks: urine cotinine <200 ng/ml]. Secondary outcome measures include: 7‐day point prevalence abstinence at weeks 1, 4, 8, 12, 16, 20 and 26 after‐quit day; self‐reported 12‐week continuous smoking abstinence and 26‐week continuous smoking abstinence; reductions in number of cigarettes smoked per day; and rates of participation in and completion of the smoking‐cessation program. Conclusions: If the 'WeChat WeQuit' program is found to be effective, it will be an accessible, affordable and widely implementable intervention to help cigarette smokers to quit. The potential public health impact of its expansion into underserved regions or communities is considerable. [ABSTRACT FROM AUTHOR]

Background and Aims: Many evidence‐based treatments (EBTs) for substance use disorder (SUD) exist, yet few are tailored to Indigenous patients. This trial tested the efficacy of a culturally tailored EBT that combined Motivational Interviewing and the Community Reinforcement Approach (MICRA) versus treatment as usual (TAU). Design A mixed efficacy/effectiveness randomized controlled trial of MICRA (n = 38) and TAU (n = 41) using a parallel design with follow‐up assessments at 4‐, 8‐, and 12‐ months post baseline. Setting United States, reservation‐based outpatient, addiction specialty care treatment program. Participants: 79 (68% male) American Indian and Alaska Native (AI/AN) Tribal members meeting criteria for SUD and seeking SUD treatment. Interventions: MICRA (individual therapy sessions beginning with MI for 2–3 sessions) compared with TAU (individual and group counseling sessions in a didactic style with Twelve‐Step philosophy and elements of relapse prevention). Measures: Demographics, percent days abstinent (PDA; the primary outcome at 12months assessed by Form 90D), Inventory of Drug Use Consequences, Alcohol and Drug Use Self‐Efficacy Scale, Native American Spirituality Scale, and SCID‐DSM‐IV‐TR. Findings There was no evidence for the benefit of MICRA over TAU (MICRA PDA = 72.63%, TAU = 73.62%, treatment effect: B = −4.04 (SE = 5.47); 95% CI = −14.941, 6.866; BF = 3.44) in the primary outcome. Both groups showed improvements in PDA, SUD severity, and negative consequences from baseline to the 12‐month follow‐up. Neither self‐efficacy nor spirituality were significant mediators of MICRA. Conclusions: There were no treatment group differences between culturally tailored evidence‐based treatments for substance use disorder and treatment as usual in this randomized controlled trial with American Indian and Alaska Native participants. Nonetheless, participants improved over time on several substance‐related outcomes. [ABSTRACT FROM AUTHOR]

Background and Aims: Recent meta‐analyses of motivational interviewing (MI) for reducing risky alcohol use in young people have reported modest effects. Few studies have targeted individual patient factors to increase MI effectiveness. This study determined if MI enhanced with individualised personality‐specific coping skills training (QuikFix) was more efficacious than standard MI or an assessment feedback/information (AF/I) control among young people with alcohol‐related injuries or illnesses. Design and Setting: Single‐centre, single‐blind, three‐group superiority randomized controlled trial with 1‐, 3‐, 6‐ and 12‐months follow‐ups. Telephone intervention, Brisbane, Australia. Participants: A total of 398 young people (16–25 years; M age = 20.30 years, SD = 2.12; 54% female) with alcohol‐related injuries and/or illnesses were recruited from an emergency department (ED) or rest/recovery service (RRS). Measures: The primary outcome was total standard (10 g ethanol) drinks in the past month (Timeline Follow back [TLFB]) at 12 months (primary time point). Secondary outcomes were total drinking days and standard drinks per drinking day (TLFB) in the past month and the frequency of alcohol‐related problems in the past 3 months (Rutgers Alcohol Problem Index). Interventions: Young people were randomized to two sessions of QuikFix enhanced with individualised personality‐specific coping skills training (n = 132), two sessions of MI (n = 136) or one session of AF/I (n = 130), all delivered by telehealth. Findings QuikFix resulted in greater reductions (all P < 0.0017) in the primary outcome of total standard drinks (M = 19.50, CI 99.75% = [11.31, 27.68]) than both MI (M = 32.61, CI 99.75% = [24.82, 40.40]; Cohen's D = 0.40) and AF/I (M = 34.12, CI 99.75% = [26.59, 41.65]; D = 0.45) at 12 months (retention n = 324/398, 81%). QuikFix had greater reductions on drinking days (M = 3.16, CI 99.75% = [2.37, 3.96]) than both MI (M = 4.53, CI 99.75% = [3.57, 5.48];D = 0.38) and AF/I (M = 4.69, CI 99.75% = [3.73, 5.65];D = 0.42) and fewer drinks per drinking day (M = 5.02, CI 99.75% = [3.71, 6.33]) than AF/I (M = 7.15, CI 99.75% = [5.93, 8.38;D = 0.47) at 12 months. Conclusions: Young people with alcohol‐related injuries and/or illnesses who attended ED and rest/recovery services and received an individualised personality‐specific coping skills training intervention (QuikFix) had greater reductions in the amount of alcohol consumed at 12 months compared with those who received motivational interviewing or an assessment feedback/information intervention. [ABSTRACT FROM AUTHOR]

Background and aim: Reducing alcohol misuse by male prisoners is an important global issue. Control of drinking behaviour could be a useful target for intervention in this population, and locus of control could be a causal factor in this. We aimed to assess the effect of a clinical psychologist‐facilitated group intervention on male prisoners' locus of control of drinking behaviour. Design A two‐arm, single‐site, open, randomized controlled trial. Setting: A category B local training prison in South Wales, housing about 770 mainly sentenced men. Participants: Prisoners serving less than 2 years who met inclusion criteria for pre‐imprisonment alcohol misuse, alone or with drug misuse. A total of 119 were allocated to the intervention arm and 119 to the control arm; 104 and 87, respectively, completed the post‐randomization baseline interview and 68 and 60 completed a second interview approximately 4 weeks later, respectively, after intervention or treatment as usual (TAU) alone. Intervention: Nine clinical psychologist‐facilitated groups in the prison over 3 weeks. Range of participants per session was one to seven, with three to five most usual. Measures: The primary outcome was locus of control of behaviour (LCB); secondary outcomes included mental state generally (comprehensive psychiatric rating scale/CPRS) and specifically (Beck Depression Inventory/BDI). An integral process evaluation was conducted. Findings LCB scores decreased during the study, but without significant intervention effect [−1.7, 95% confidence interval (CI) = –5.1 to 1.6, P = 0.329]. Change among completers in the control group was from a mean score of 37.4 [standard deviation (SD) = 10.0] to 33.7[SD = 11.7] and in the intervention group from 37.4 (SD = 11.6) to 31.9 (SD = 11.8). Secondary outcomes, including change in mental state, did not differ between arms, but 686 (64%) sessions were lost, most because of 'prison issues'. Conclusions: A clinical psychologist‐facilitated group intervention did not have a statistically significant effect on sense of control of drinking behaviour among men with pre‐imprisonment alcohol misuse serving less than 2 years in a South Wales prison. The study proved coterminous, however, with 40% prison staff cuts which seem likely to have contributed to the high loss of group sessions and possibly overwhelmed any treatment effect. Intervention completion failures, previously cited as harmful, had no effect here, so the trial should be repeated when the prison climate improves. [ABSTRACT FROM AUTHOR]

Background and aims: Smoking cessation medications are effective, but often underutilized because of costs and side effects. Cytisine is a plant‐based smoking cessation medication with more than 50 years of use in central and eastern Europe. While cytisine has been found to be well‐tolerated and more effective than nicotine replacement therapy, direct comparisons with varenicline have not been conducted. This study evaluates the effectiveness, safety and cost‐effectiveness of cytisine compared with varenicline. Design Two‐arm, parallel group, randomized, non‐inferiority trial, with allocation concealment and blinded outcome assessment. Setting: Australian population‐based study. Participants: Adult daily smokers (n = 1266) interested in quitting will be recruited through advertisements and Quitline telephone‐based cessation support services. Intervention and comparator: Eligible participants will be randomized (1 : 1 ratio) to receive either cytisine capsules (25‐day supply) or varenicline tablets (12‐week supply), prescribed in accordance with the manufacturer's recommended dosing regimen. The medication will be mailed to each participant's nominated residential address. All participants will also be offered standard Quitline behavioural support (up to six 10–12‐minute sessions). Measurements Assessments will be undertaken by telephone at baseline, 4 and 7 months post‐randomization. Participants will also be contacted twice (2 and 4 weeks post‐randomization) to ascertain adverse events, treatment adherence and smoking status. The primary outcome will be self‐reported 6‐month continuous abstinence from smoking, verified by carbon monoxide at 7‐month follow‐up. We will also evaluate the relative safety and cost‐effectiveness of cytisine compared with varenicline. Secondary outcomes will include self‐reported continuous and 7‐day point prevalence abstinence and cigarette consumption at each follow‐up interview. Comments If cytisine is as effective as varenicline, its lower cost and natural plant‐based composition may make it an acceptable and affordable smoking cessation medication that could save millions of lives world‐wide. [ABSTRACT FROM AUTHOR]

An editorial is presented on an extension to the Consolidated Standards of Reporting Trials (CONSORT) 2010 Statement for social and psychological interventions (CONSORT-SPI 2018) to help behavioural and social scientists report these studies transparently.

Abstract: Aims: To assess the cost‐effectiveness of a two‐component intervention designed to increase attendance at the NHS Stop Smoking Services (SSSs) in England. Design: Cost‐effectiveness analysis alongside a randomized controlled trial (Start2quit). Setting: NHS SSS and general practices in England. Participants: The study comprised 4384 smokers aged 16 years or more identified from medical records in 99 participating practices, who were motivated to quit and had not attended the SSS in the previous 12 months. Intervention and comparator: Intervention was a personalized and tailored letter sent from the general practitioner (GP) and a personal invitation and appointment to attend a taster session providing information about SSS. Control was a standard generic letter from the GP advertising SSS and asking smokers to contact the service to make an appointment. Measurements: Costs measured from an NHS/personal social services perspective, estimated health gains in quality‐adjusted life‐years (QALYs) measured with EQ‐5D and incremental cost per QALY gained during both 6 months and a life‐time horizon. Findings: During the trial period, the adjusted mean difference in costs was £92 [95% confidence interval (CI) = –£32 to –£216) and the adjusted mean difference in QALY gains was 0.002 (95% CI = –0.001 to 0.004). This generates an incremental cost per QALY gained of £59 401. The probability that the tailored letter and taster session is more cost‐effective than the generic letter at 6 months is never above 50%. In contrast, the discounted life‐time health‐care cost was lower in the intervention group, while the life‐time QALY gains were significantly higher. The probability that the intervention is more cost‐effective is more than 83% using a £20 000–30 000 per QALY‐gained decision‐making threshold. Conclusions: An intervention designed to increase attendance at the NHS Stop Smoking Services (tailored letter and taster session in the services) appears less likely to be cost‐effective than a generic letter in the short term, but is likely to become more cost‐effective than the generic letter during the long term. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aims: Pharmacologically controlled drinking in the treatment of alcohol dependence or alcohol use disorders (AUDs) is an emerging concept. Our objective was to explore the comparative effectiveness of drugs used in this indication. Design: Systematic review with direct and network meta‐analysis of double‐blind randomized controlled trials (RCTs) assessing the efficacy of nalmefene, naltrexone, acamprosate, baclofen or topiramate in non‐abstinent adults diagnosed with alcohol dependence or AUDs. Two independent reviewers selected published and unpublished studies on Medline, the Cochrane Library, Embase, ClinicalTrials.gov, contacted pharmaceutical companies, the European Medicines Agency and the Food and Drug Administration, and extracted data. Setting: Thirty‐two RCTs. Participants: A total of 6036 patients. Measurements: The primary outcome was total alcohol consumption (TAC). Other consumption outcomes and health outcomes were considered as secondary outcomes. Findings: No study provided direct comparisons between drugs. A risk of incomplete outcome data was identified in 26 studies (81%) and risk of selective outcome reporting in 17 (53%). Nalmefene [standardized mean difference (SMD) = −0.19, 95% confidence interval (CI) = −0.29, –0.10; I2 = 0%], baclofen (SMD = −1.00, 95% CI = −1.80, −0.19; one study) and topiramate (SMD = −0.77, 95% CI = −1.12, –0.42; I2 = 0%) showed superiority over placebo on TAC. No efficacy was observed for naltrexone or acamprosate. Similar results were observed for other consumption outcomes, except for baclofen (the favourable outcome on TAC was not reproduced). The number of withdrawals for safety reasons increased under nalmefene and naltrexone. No treatment demonstrated any harm reduction (no study was powered to explore health outcomes). Indirect comparisons suggested that topiramate was superior to nalmefene, naltrexone and acamprosate on consumption outcomes, but its safety profile is known to be poor. Conclusions: There is currently no high‐grade evidence for pharmacological treatment to control drinking using nalmefene, naltrexone, acamprosate, baclofen or topiramate in patients with alcohol dependence or alcohol use disorder. Some treatments show low to medium efficacy in reducing drinking across a range of studies with a high risk of bias. None demonstrates any benefit on health outcomes. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Methamphetamine use is increasingly prevalent and associated with HIV transmission. Early‐phase human studies suggested naltrexone reduced amphetamine use among dependent individuals. We tested if extended‐release naltrexone (XRNTX) reduces methamphetamine use and associated sexual risk behaviors among high‐risk methamphetamine‐dependent men who have sex with men (MSM). Design: Double‐blind, placebo‐controlled, randomized trial of XRTNX versus placebo over 12 weeks from 2012 to 2015. Setting: San Francisco Department of Public Health, California, USA. Participants: One hundred community‐recruited, sexually‐active, actively‐using methamphetamine‐dependent MSM. Mean age was 43.2 years; 96% were male, 3% transfemale, and 1% transmale; 55.0% were white, 19.0% African American, and 18.0% Latino. Interventions: XRNTX 380 mg (n = 50) or matched placebo (n = 50) administered by gluteal injection at 4‐week intervals. Measurements: Regression estimated average level and change in level of positive urines during the period 2–12 weeks (primary outcomes) and sexual risk behaviors (secondary outcome). Findings: Ninety per cent of visits were completed. By intent‐to‐treat, participants assigned to XRNTX had similar differences during 2–12 weeks in methamphetamine‐positive urines as participants assigned to placebo [incidence rate ratio (IRR) = 0.95, 95% confidence interval (CI) = 0.76–1.20; Bayes factor < 0.3]. Observed urine positivity declined from 78 to 70% in the XRNTX arm and 74 to 64% in the placebo arm. Adherence to injections was 96.7% in the XRNTX arm and 91.3% in the placebo arm. Sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug and no differences in frequency of adverse events by treatment arm. Conclusions: Notwithstanding very high medication adherence for this study, extended‐release naltrexone does not appear to reduce methamphetamine use or sexual risk behaviors among methamphetamine‐dependent men who have sex with men compared with placebo. [ABSTRACT FROM AUTHOR]

Background and Aims Premises licensed for the sale and consumption of alcohol can contribute to levels of assault-related injury through poor operational practices that, if addressed, could reduce violence. We tested the real-world effectiveness of an intervention designed to change premises operation, whether any intervention effect changed over time, and the effect of intervention dose. Design A parallel randomized controlled trial with the unit of allocation and outcomes measured at the level of individual premises. Setting All premises (public houses, nightclubs or hotels with a public bar) in Wales, UK. Participants A randomly selected subsample ( n = 600) of eligible premises (that had one or more violent incidents recorded in police-recorded crime data; n = 837) were randomized into control and intervention groups. Intervention and comparator Intervention premises were audited by Environmental Health Practitioners who identified risks for violence and provided feedback by varying dose (informal, through written advice, follow-up visits) on how risks could be addressed. Control premises received usual practice. Measurements Police data were used to derive a binary variable describing whether, on each day premises were open, one or more violent incidents were evident over a 455-day period following randomization. Findings Due to premises being unavailable at the time of intervention delivery 208 received the intervention and 245 were subject to usual practice in an intention-to-treat analysis. The intervention was associated with an increase in police recorded violence compared to normal practice (hazard ratio = 1.34, 95% confidence interval = 1.20-1.51). Exploratory analyses suggested that reduced violence was associated with greater intervention dose (follow-up visits). Conclusion An Environmental Health Practitioner-led intervention in premises licensed for the sale and on-site consumption of alcohol resulted in an increase in police recorded violence. [ABSTRACT FROM AUTHOR]

Background and aims There is inconsistent evidence that behavioural support to promote smoking reduction is effective at increasing smoking cessation. We examined the effectiveness of brief physician advice together with four very brief telephone calls in promoting smoking cessation among Chinese men via reduction compared with equivalent advice on diet and exercise. Design A two-group pragmatic randomized controlled trial. Participants and Setting Male patients attending the Endocrinology and Acupuncture out-patient clinics of a general hospital in Beijing, China. Intervention and comparators Physicians advised participants allocated to the smoking-reduction intervention (SRI, n = 181) group to reduce smoking to at least half of their current consumption within 1 month at baseline. At follow-up, a telephone counsellor repeated this advice if the participant had not reduced their cigarette consumption. Participants who had reduced consumption were encouraged to quit smoking. Physicians gave participants in the exercise and diet advice (EDA, n = 188) control group brief advice about physical activity and healthy diet at baseline, and a telephone counsellor reinforced this at each follow-up interview. Both groups had one face-to-face interview at baseline plus five telephone interviews and interventions (approximately 1 minute each) at 1 week and 1-, 3-, 6- and 12-month follow-up. Measurements The primary outcome was self-reported 6-month prolonged abstinence rate at 12-month follow-up interview. Findings By intention-to-treat, the self-reported 6-month prolonged abstinence rate at 12-month follow-up in the SRI groups (19 quitters, 15.7%) was higher, but not significantly, than the EDA control group (10 quitters, 7.8%), and the adjusted odds ratio (OR) and 95% confidence interval (CI) was 2.26 (0.97-5.26), P = 0.062. The self-reported 7-day point prevalence quit rate (secondary outcome) in the SRI group was significantly higher than the control group at each follow-up interview (at 12-month follow-up: 13.3 versus 6.9%, OR (95% CI) = 2.09 (1.01, 4.34), P = 0.049). Conclusions A very brief, proactive and low-cost smoking-reduction intervention without medications for Chinese male smokers with no intention to quit appears to increase smoking abstinence. [ABSTRACT FROM AUTHOR]

Aim To study the effectiveness of a brief intervention (BI) associated with the ASSIST (Alcohol Smoking and Substance Involvement Screening Test) for alcohol and illicit drug use as part of a systematic screening program implemented in primary care. Design A multi-center randomized open-label trial stratified using the ASSIST-specific substance involvement score (for alcohol, scores ranged from 11 to 15 and 16 to 20; and for the other substances from 4 to 12 and 13 to 20). Setting A total of 19 primary care centers ( n = 520), eight emergency rooms ( n = 195) and five police stations ( n = 91) were evaluated. Participants A total of 12 217 people aged between 19 and 55 years were screened for moderate alcohol and drug use risk as defined by the ASSIST Chilean version. A total of 806 non-treatment-seekers were randomized. Intervention and comparison ASSIST-linked BI ( n = 400) compared with an informational pamphlet on risk associated with substance use ( n = 406). Measurements Total ASSIST alcohol and illicit involvement score (ASSIST-AI), and ASSIST-specific score for alcohol, cannabis and cocaine at baseline and at 3-month follow-up. Findings Sixty-two per cent of participants completed follow-up. An intention-to-treat analysis showed no difference between the two groups for the ASSIST-AI score [mean difference (MD) = − 0.17, confidence interval (CI) = −1.87, 2.20], either for specific scores alcohol (MD = 0.18, CI = −1.45, 1.10), cannabis (MD = -0.62, CI = −0.89, 2.14) or cocaine (MD = -0.79, CI = −2.89, 4.47). Conclusion It is not clear whether a brief intervention associated with the Alcohol Smoking and Substance Involvement Screening Test is more effective than an informational pamphlet in reducing alcohol and illicit substance consumption in non-treatment-seeking, primary care users with moderate risk. [ABSTRACT FROM AUTHOR]

Aims To estimate the effectiveness of pregnancy smoking cessation support delivered by short message service (SMS) text message and key parameters needed to plan a definitive trial. Design Multi-centre, parallel-group, single-blinded, individual randomized controlled trial. Setting Sixteen antenatal clinics in England. Participants Four hundred and seven participants were randomized to the intervention ( n = 203) or usual care ( n = 204). Eligible women were < 25 weeks gestation, smoked at least one daily cigarette (> 5 pre-pregnancy), were able to receive and understand English SMS texts and were not already using text-based cessation support. Intervention All participants received a smoking cessation leaflet; intervention participants also received a 12-week programme of individually tailored, automated, interactive, self-help smoking cessation text messages (MiQuit). Outcome measurements Seven smoking outcomes, including validated continuous abstinence from 4 weeks post-randomization until 36 weeks gestation, design parameters for a future trial and cost-per-quitter. Findings Using the validated, continuous abstinence outcome, 5.4% (11 of 203) of MiQuit participants were abstinent versus 2.0% (four of 204) of usual care participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 0.93-9.35]. The Bayes factor for this outcome was 2.23. Completeness of follow-up at 36 weeks gestation was similar in both groups; provision of self-report smoking data was 64% (MiQuit) and 65% (usual care) and abstinence validation rates were 56% (MiQuit) and 61% (usual care). The incremental cost-per-quitter was £133.53 (95% CI = -£395.78 to 843.62). Conclusions There was some evidence, although not conclusive, that a text-messaging programme may increase cessation rates in pregnant smokers when provided alongside routine NHS cessation care. [ABSTRACT FROM AUTHOR]

Aims To test whether, in comparison to usual care, brief motivational or reduction interventions increase quit attempts (QA) or abstinence among smokers who are not ready to quit. Design A parallel-group randomized controlled trial of brief motivational ( n = 185), reduction ( n = 186) or usual care ( n = 189) telephone interventions delivered over the course of 4 weeks. Outcomes were assessed at 6- and 12-month follow-ups. No medication was provided. Setting United States. Participants A total of 560 adult smokers of ≥ 10 cigarettes per day who were not ready to quit in the next 30 days. Measurements The primary outcomes were whether participants made a QA that lasted ≥ 24 hours and whether they made a QA of any length between baseline and 6 months. Secondary outcomes included 7-day point-prevalence abstinence at 6 and 12 months. The 12-month follow-up was added after the study began. Findings A priori-defined comparisons were between motivational versus usual care and reduction versus usual care conditions. The probability of making a QA that lasted ≥ 24 hours was not significantly different between the motivational (38%) or the reduction (31%) conditions and the usual care (34%) condition [motivational versus usual care odds ratio (OR) = 1.19, 95% confidence interval (CI) = 0.78-1.82; reduction versus usual care OR = 0.89, 95% CI = 0.57-1.36]. Bayes factors ranged from 0.13 to 0.18. Findings regarding a QA of any length were similar. At 6 months, the motivational condition had marginally more abstinence than usual care (11 versus 5%, OR = 2.17, 95% CI = 0.99-4.77), but the reduction condition was not significantly different from usual care (8 versus 5%, OR = 1.57, 95% CI = 0.69-3.59). At 12 months, the motivational condition had significantly more abstinence than usual care (10 versus 4%, OR = 2.80, 95% CI = 1.14-6.88) and the reduction condition had marginally more abstinence than usual care (9 versus 4%, OR = 2.45, 95% CI = 0.98-6.09). Conclusions Among adult smokers who are not ready to quit, both logistic regression and Bayesian analysis indicate that neither motivational nor reduction-based telephone interventions increased the odds of making a quit attempt in comparison to usual care at 6 months. The motivational intervention appeared to increase abstinence at 6 months and did increase abstinence at 12 months. The reduction intervention did not increase abstinence at 6 months but appeared to increase abstinence at 12 months. [ABSTRACT FROM AUTHOR]

Aim To compare the effectiveness of proactive telephone counselling, reactive telephone counselling and an internet- and text-message-based intervention with a self-help booklet for smoking cessation. Design A randomized controlled trial with equal allocation to four conditions: (1) proactive telephone counselling ( n = 452), (2) reactive telephone counselling ( n = 453), (3) internet- and text-message-based intervention ( n = 453) and (4) self-help booklet (control) ( n = 452). Setting Denmark. Participants Smokers who had participated previously in two national health surveys were invited. Eligibility criteria were daily cigarette smoking, age ≥ 16 years, having a mobile phone and e-mail address. Measurements Primary outcome was prolonged abstinence to 12 months from the end of the intervention period. Findings At 12-month follow-up, higher prolonged abstinence was found in the proactive telephone counselling group compared with the booklet group [7.3 versus 3.6%, odds ratio (OR) = 2.2, 95% confidence interval (CI) = 1.2-4.0]. There was no clear evidence of a difference in prolonged abstinence between the reactive telephone counselling group or the internet-based smoking cessation program and the booklet group: 1.8 versus 3.6%, OR = 0.8, 95% CI = 0.6-1.2 and 5.3 versus 3.6%, OR = 1.6, 95% CI = 0.8-3.0, respectively. In the proactive telephone counselling group, the cost per additional 12-month quitter compared with the booklet group was £644. Conclusions Proactive telephone counselling was more effective than a self-help booklet in achieving prolonged abstinence for 12 months. No clear evidence of an effect of reactive telephone counselling or the internet- and text-message-based intervention was found compared with the self-help booklet. [ABSTRACT FROM AUTHOR]

Aims In pregnant smoking cessation trial participants, to estimate (1) among women abstinent at the end of pregnancy, the proportion who re-start smoking at time-points afterwards (primary analysis) and (2) among all trial participants, the proportion smoking at the end of pregnancy and at selected time-points during the postpartum period (secondary analysis). Methods Trials identified from two Cochrane reviews plus searches of Medline and EMBASE. Twenty-seven trials were included. The included trials were randomized or quasi-randomized trials of within-pregnancy cessation interventions given to smokers who reported abstinence both at end of pregnancy and at one or more defined time-points after birth. Outcomes were validated biochemically and self-reported continuous abstinence from smoking and 7-day point prevalence abstinence. The primary random-effects meta-analysis used longitudinal data to estimate mean pooled proportions of re-starting smoking; a secondary analysis used cross-sectional data to estimate the mean proportions smoking at different postpartum time-points. Subgroup analyses were performed on biochemically validated abstinence. Results The pooled mean proportion re-starting at 6 months postpartum was 43% [95% confidence interval (CI) = 16-72%, I2 = 96.7%] (11 trials, 571 abstinent women). The pooled mean proportion smoking at the end of pregnancy was 87% (95% CI = 84-90%, I2 = 93.2%) and 94% (95% CI = 92-96%, I2 = 88%) at 6 months postpartum (23 trials, 9262 trial participants). Findings were similar when using biochemically validated abstinence. Conclusions In clinical trials of smoking cessation interventions during pregnancy only 13% are abstinent at term. Of these, 43% re-start by 6 months postpartum. [ABSTRACT FROM AUTHOR]

Background and Aims Relapse to addiction following incarceration is common. We estimated the feasibility and effectiveness of extended-release naltrexone (XR-NTX) as relapse prevention among opioid-dependent male adults leaving a large urban jail. Design Eight-week, proof-of-concept, open-label, non-blinded randomized effectiveness trial. Setting New York City jails and Bellevue Hospital Center Adult Primary Care clinics, USA. Participants From January 2010 to July 2013, 34 opioid-dependent adult males with no stated interest in agonist treatments (methadone, buprenorphine) received a counseling and referral intervention and were randomized to XR-NTX ( n = 17) versus no medication ( n = 17) within one week prior to jail release. Intervention XR-NTX (Vivitrol®; Alkermes Inc.), a long-acting injectable mu opioid receptor antagonist. Measures The primary intent-to-treat outcome was post-release opioid relapse at week 4, defined as ≥10 days of opioid misuse by self-report and urine toxicologies. Secondary outcomes were proportion of urine samples negative for opioids and rates of opioid abstinence, intravenous drug use (IVDU), cocaine use, community treatment participation, re-incarceration and overdose. Findings Acceptance of XR-NTX was high; 15 of 17 initiated treatment. Rates of the primary outcome of week 4 opioid relapse were lower among XR-NTX participants: 38 versus 88% [ P<0.004; odds ratio (OR) = 0.08, 95% confidence interval (CI) = 0.01-0.48]; more XR-NTX urine samples were negative for opioids, 59 versus 29% ( P<0.009; OR = 3.5, 95% CI = 1.4-8.5). There were no significant differences in the remaining secondary outcomes, including rates of IVDU, cocaine use, re-incarceration and overdose. Conclusion Extended-release naltrexone is associated with significantly lower rates of opioid relapse among men in the United States following release from jail when compared with a no medication treatment-as-usual condition. [ABSTRACT FROM AUTHOR]

Aim We tested the efficacy of a brief intervention based on motivational interviewing (MI) to reduce high-risk injection behaviours over a 6-month period among people who inject drugs (PWID). Design A single-site two-group parallel randomized controlled trial comparing MI with a brief educational intervention (EI). Setting A study office located in downtown Montréal, Canada, close to the community-based harm reduction programmes where PWID were recruited. Participants PWID who had shared drug injection equipment or shared drugs by backloading or frontloading in the month prior to recruitment were randomized to either the MI (112) or EI (109) groups. Intervention The MI aimed to (1) encourage PWID to voice their desires, needs and reasons to change behaviours; (2) boost motivation to change behaviours; and (3) when the person was ready, support the plan he or she chose to reduce injection risk behaviours. The EI consisted of an individual session about safe injection behaviours. Measurements The primary outcome was defined as having any of these risk behaviours at 6 months: having shared syringes, containers, filters or water to inject drugs in the previous month and backloading/frontloading; each behaviour was examined separately, as secondary outcomes. Findings The probability of reporting a risk injection behaviour decreased in both the MI and the EI groups. At 6-month follow-up, participants who reported any risk behaviours were 50% [odds ratio (OR) = 0.50; confidence interval (CI) = 0.13-0.87] less likely to be in the MI group than in the EI group as well as those who reported sharing containers (OR = 0.50; CI = 0.09-0.90). PWID who reported sharing equipment excluding syringes were 53% less likely to be in the MI group (OR = 0.47; CI = 0.11-0.84). Conclusions A brief motivational interviewing intervention was more effective than a brief educational intervention in reducing some high risk injecting behaviours up in the subsequent 6 months. [ABSTRACT FROM AUTHOR]

Background and Aims Tuberculosis ( TB) patients who smoke risk adverse TB outcomes and other long-term health effects of smoking. This study aimed to determine the efficacy of brief motivational interviewing by lay health-care workers ( LHCWs) in assisting TB patients to quit smoking. Design Multi-centre two-group parallel individual randomized controlled trial. Setting Six primary care tuberculosis clinics in a South African township. Participants Newly diagnosed adult TB patients identified as current smokers were randomized to brief motivational interviewing by a LHCW (intervention group, n = 205) or brief smoking cessation advice from a TB nurse (control group, n = 204). Measurements The primary outcome was self-reported sustained 6-month smoking abstinence. Exhaled carbon monoxide ( CO) testing was offered to about half the participants. Secondary outcomes were sustained abstinence at 3 months; 7-day point prevalence abstinence at 1, 3 and 6 months; and quit attempts. Allocation was concealed. Primary analysis relied on intention to treat. Multi-level analysis accounted for site heterogeneity of effect. Findings Self-reported 6-month sustained abstinence was 21.5% for the intervention group versus 9.3% for the control group [relative risk ( RR) = 2.29, 95% confidence interval ( CI) = 1.34, 3.92]. Biochemically verified 6-month sustained abstinence was also higher in the intervention group ( RR 2.21, 95% CI = 1.08, 4.51) for the 166 participants who were offered carbon monoxide testing. Self-reported 3-month sustained abstinence was 25.4% for the intervention group and 12.8% for the control group ( RR = 1.98, 95% CI = 1.24, 3.18). Conclusions Motivational interviewing by lay counsellors to promote smoking cessation in tuberculosis patients in South Africa approximately doubled sustained smoking abstinence for at least 6 months compared with brief advice alone. [ABSTRACT FROM AUTHOR]

Aims To investigate whether or not a stage tailored intervention is more effective than a non-stage tailored intervention of the same intensity in reducing alcohol use among job-seekers with unhealthy alcohol use, and whether initial motivation to change is a moderator of efficacy. Design A three-group randomized controlled trial with 3-, 6- and 15-month follow-ups. Setting Three job agencies in Germany. Participants A total of 1243 job-seekers with unhealthy alcohol use were randomized to (i) stage tailored intervention based on the transtheoretical model of change ( ST), (ii) non-stage tailored intervention based on the theory of planned behaviour ( NST) and (iii) assessment only (controls). Participants received feedback letters and manuals at baseline and 3 months later. Measurements Piecewise latent growth models were calculated measuring change in 'alcohol use' from baseline to month 3 (active intervention phase) and from months 3 to 15 (post-intervention phase, primary outcome). Motivation to change was included as a 4-point continuous measure. Findings All groups reduced alcohol use from months 0 to 3 (controls: mean = −0.866, NST: mean = −0.883, ST: mean = −0.718, Ps ≤ 0.001). Post-intervention (months 3-15), low-motivated individuals in the ST group showed a greater reduction than those in the control group (β = 0.135, P = 0.039, Cohen's d = 0.42) and in the NST group (β = 0.180, P = 0.009, Cohen's d = 0.55). In contrast, compared to the ST group (β = 0.030, P = 0.361), alcohol use decreased more strongly with higher initial motivation in the NST group (β = −0.118, P = 0.010). Conclusions Among job-seekers with high levels of alcohol consumption, an intervention tailored to motivational 'stage of change' was more effective than a non-stage tailored intervention for reducing alcohol use 15 months after baseline assessment in participants with low initial motivation to change. [ABSTRACT FROM AUTHOR]

Aims To compare a motivational intervention ( MI) focused on increasing involvement in 12-Step groups ( TSGs; e.g. Alcoholics Anonymous) versus brief advice ( BA) to attend TSGs. Design Patients were assigned randomly to either the MI or BA condition, and followed-up at 6 months after discharge. Setting and participants One hundred and forty substance use disorder ( SUD) patients undergoing in-patient detoxification (detox) in Norway. Measurements The primary outcome was TSG affiliation measured with the Alcoholics Anonymous Affiliation Scale ( AAAS), which combines meeting attendance and TSG involvement. Substance use and problem severity were also measured. Findings At 6 months after treatment, compared with the BA group, the MI group had higher TSG affiliation [0.91 point higher AAAS score; 95% confidence interval ( CI) = 0.04 to 1.78; P = 0.041]. The MI group reported 3.5 fewer days of alcohol use (2.1 versus 5.6 days; 95% CI = −6.5 to −0.6; P = 0.020) and 4.0 fewer days of drug use (3.8 versus 7.8 days; 95% CI = −7.5 to −0.4; P = 0.028); however, abstinence rates and severity scores did not differ between conditions. Analyses controlling for duration of in-patient treatment did not alter the results. Conclusions A motivational intervention in an in-patient detox ward was more successful than brief advice in terms of patient engagement in 12-Step groups and reduced substance use at 6 months after discharge. There is a potential benefit of adding a maintenance-focused element to standard detox. [ABSTRACT FROM AUTHOR]

Aims Effectiveness of nicotine replacement therapy ( NRT) for smoking cessation has not been evaluated in low income countries, such as Syria, where it is expensive and not widely available. We evaluated whether nicotine patch boosts smoking cessation rates when used in conjunction with behavioral support in primary care clinics in Aleppo, Syria. Design Two arm, parallel group, randomized, placebo controlled, double-blinded multi-site trial. Setting Four primary care clinics in Aleppo, Syria. Participants Two hundred and sixty-nine adult primary care patients received behavioral cessation counseling from a trained primary care physician and were randomized to receive six weeks of treatment with nicotine versus placebo patch. Measurements Primary end-points were prolonged abstinence (no smoking after a 2-week grace period) at end of treatment, and 6 and 12 months post-quit day, assessed by self-report and exhaled carbon monoxide levels of <10 p.p.m. Findings Treatment adherence was excellent and nicotine patch produced expected reductions in urges to smoke and withdrawal symptoms, but no treatment effect was observed. The proportion of patients in the nicotine and placebo groups with prolonged abstinence was 21.6% and 20.0%, respectively, at end of treatment, 13.4% and 14.1% at 6 months, and 12.7% and 11.9% at 12 months. Conclusions Nicotine patches may not be effective in helping smokers in low-income countries to stop when given as an adjunct to behavioural support. [ABSTRACT FROM AUTHOR]

Aims Active recruitment of smokers increases the reach of quitlines; however, some quitlines restrict proactive telephone counselling (i.e. counsellor-initiated calls) to smokers ready to quit within 30 days. Identifying characteristics associated with successful quitting by actively recruited smokers could help to distinguish those most likely to benefit from proactive telephone counselling. This study assessed the baseline characteristics of actively recruited smokers associated with prolonged abstinence at 4, 7 and 13 months and the proportion achieving prolonged abstinence that would miss out on proactive telephone counselling if such support was offered only to smokers intending to quit within 30 days at baseline. Design Secondary analysis of a randomized controlled trial in which the baseline characteristics associated with prolonged abstinence were examined. Setting New South Wales ( NSW) community, Australia. Participants A total of 1562 smokers recruited at random from the electronic NSW telephone directory. Measurements Baseline socio-demographic and smoking-related characteristics associated with prolonged abstinence at 4, 7 and 13 months post-recruitment. Findings Waiting more than an hour to smoke after waking and intention to quit within 30 days at baseline predicted five of the six prolonged abstinence measures. If proactive telephone counselling was restricted to smokers who at baseline intended to quit within 30 days, 53.8-65.9% of experimental group participants who achieved prolonged abstinence would miss out on telephone support. Conclusions Less addicted and more motivated smokers who are actively recruited to quitline support are more likely to achieve abstinence. Most actively recruited smokers reported no intention to quit within the next 30 days, but such smokers still achieved long-term abstinence. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To investigate individual traffic-relevant impairment related to measured blood zopiclone and ethanol concentrations. Also, we aimed to study possible development of acute tolerance. Design A randomized controlled four-way cross-over double-blind trial. Study drugs were zopiclone 5 or 10 mg, 50 g ethanol or placebo. Setting Laboratory study with computerized tests: Connor's Continuous Performance test, Choice Reaction Time and Stockings of Cambridge. Altogether, the tests consisted of 15 test components, representing three levels of behaviour (automotive, control, executive planning), relevant to traffic safety. Participants Sixteen healthy male volunteers. Measurements Each study day, 10 blood samples were collected from each volunteer. Fifteen psychomotor test components were registered at baseline and a further three times after intake. Impairment was defined as any individual deterioration in performance compared to individual baseline performance. Findings Blood drug concentrations up to 74 µg/l zopiclone and 0.100% ethanol were measured. We found a clear positive concentration-effect relationship for zopiclone and ethanol for both automotive and control behaviours, and a modest relationship for executive planning behaviour. Significant impairment started to be observed at concentrations above 16 µg/l zopiclone (automotive and control behaviour) and above 0.026% ethanol (automotive behaviour). Acute tolerance was found for both drugs. Conclusions The hypnotic, zopiclone, can impair psychomotor performance at blood concentrations as low as 16 µg/l. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study evaluated the effectiveness of a brief intervention (BI) for illicit drugs (cannabis, cocaine, amphetamine-type stimulants and opioids) linked to the World Health Organization (WHO) Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The ASSIST screens for problem or risky use of 10 psychoactive substances, producing a score for each substance that falls into either a low-, moderate- or high-risk category. Design Prospective, randomized controlled trial in which participants were either assigned to a 3-month waiting-list control condition or received brief motivational counselling lasting an average of 13.8 minutes for the drug receiving the highest ASSIST score. Setting Primary health-care settings in four countries: Australia, Brazil, India and the United States. Participants A total of 731 males and females scoring within the moderate-risk range of the ASSIST for cannabis, cocaine, amphetamine-type stimulants or opioids. Measurements ASSIST-specific substance involvement scores for cannabis, stimulants or opioids and ASSIST total illicit substance involvement score at baseline and 3 months post-randomization. Findings Omnibus analyses indicated that those receiving the BI had significantly reduced scores for all measures, compared with control participants. Country-specific analyses showed that, with the exception of the site in the United States, BI participants had significantly lower ASSIST total illicit substance involvement scores at follow-up compared with the control participants. The sites in India and Brazil demonstrated a very strong brief intervention effect for cannabis scores ( P < 0.005 for both sites), as did the sites in Australia ( P < 0.005) and Brazil ( P < 0.01) for stimulant scores and the Indian site for opioid scores ( P < 0.01). Conclusions The Alcohol, Smoking and Substance Involvement Screening Test-linked brief intervention aimed at reducing illicit substance use and related risks is effective, at least in the short term, and the effect generalizes across countries. [ABSTRACT FROM AUTHOR]

ABSTRACT Aim To examine the effectiveness of a stage-matched smoking cessation counselling intervention for smokers who had cardiac diseases. Methods A total of 1860 Chinese cardiac patients who smoked at least one cigarette in the past 7 days and aged 18 years or above recruited from cardiac out-patient clinics in Hong Kong hospitals were allocated randomly to an intervention group or control group. The intervention group ( n = 938) received counselling matched with their stage of readiness to quit by trained counsellors at baseline, 1 week and 1 month. The control group ( n = 922) received brief counselling on healthy diet at baseline. The primary outcomes were self-reported 7-day and 30-day point prevalence (PP) of tobacco abstinence at 12 months after baseline. The secondary outcome measures included biochemically validated abstinence at 12-month follow-up, self-reported 7-day and 30-day PP abstinence and reduction of cigarette consumption by 50% at 3 and 6 months. Results By intention-to-treat analysis, the intervention and control groups showed no significant difference in self-reported 7-day PP abstinence (intervention: 26.5% versus control: 25.5%; P = 0.60) and 30-day PP (intervention: 25.4% versus control: 24.2%; P = 0.55), biochemically validated abstinence (intervention: 6.6% versus control: 4.9%; P = 0.14) and overall quit attempts of least 24 hours (intervention: 40.3% versus control: 34.3%; P = 0.007) at the 12-month follow-up, adjusted for the baseline stage of readiness to quit smoking. Conclusions An intervention, based on the Stages of Change model, to promote smoking cessation in cardiac patients in China failed to find any long-term benefit. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To review and analyse in experimentally controlled studies the impact of alcohol consumption on intentions to engage in unprotected sex. To draw conclusions with respect to the question of whether alcohol has an independent effect on the incidence of human immunodeficiency virus (HIV) and other sexually transmitted infections (STIs). Methods A systematic review and meta-analysis of randomized controlled studies examined the association between blood alcohol content (BAC) and self-perceived likelihood of using a condom during intercourse. The systematic review and meta-analysis were conducted according to internationally standardized protocols (Preferred Reporting Items for Systematic Reviews and Meta-Analyses: PRISMA). The meta-analysis included an estimate of the dose-response effect, tests for publication bias and sensitivity analyses. Results Of the 12 studies included in the quantitative synthesis, our pooled analysis indicated that an increase in BAC of 0.1 mg/ml resulted in an increase of 5.0% (95% CI: 2.8-7.1%) in the indicated likelihood (indicated by a Likert scale) of engaging in unprotected sex. After adjusting for potential publication bias, this estimate dropped to 2.9% (95% CI: 2.0-3.9%). Thus, the larger the alcohol intake and the subsequent level of BAC, the higher the intentions to engage in unsafe sex. The main results were homogeneous, persisted in sensitivity analyses and after correction for publication bias. Conclusions Alcohol use is an independent risk factor for intentions to engage in unprotected sex, and as risky sex intentions have been shown to be linked to actual risk behavior, the role of alcohol consumption in the transmission of HIV and other STIs may be of public health importance. [ABSTRACT FROM AUTHOR]

To assess the effectiveness of a peer-based, personal risk network-focused HIV prevention intervention to (i) train injection drug users (IDUs) to reduce injection and sex risk behaviors, (ii) conduct outreach to behaviorally risky individuals in their personal social networks [called risk network members (RNM)], and (iii) reduce RNM HIV risk behaviors. Randomized controlled trial with prospective data collection at 6, 12 and 18 months. Intervention condition consisted of five group sessions, one individual session and one session with Index and the RNM. This study was conducted in Baltimore, Maryland from March 2004 to March 2006. (i) Index participants were aged ≥18 years and self-reported injection drug use in the prior 6 months and (ii) their RNM who were aged ≥18 years and drug users or sex partners of Index. Outcomes included: (i) injection risk based on sharing needles, cookers and cotton for injection and drug splitting, (ii) sex risk based on number of sex partners, condom use and exchanging sex and (iii) Index HIV outreach behaviors. A total of 227 Index participants recruited 336 RNM. Retention of Index at 18-month follow-up exceeded 85%. Findings suggest that the experimental condition was efficacious at 18 months in reducing Index participant injection risk [odds ratio (OR) = 0.38; 95% confidence interval (CI) = 0.18-0.77), drug-splitting risk (OR = 0.46; 95% CI = 0.25-0.88) and sex risk among Index (OR = 0.53; 95% CI = 0.34-0.86). Significant intervention effect on increased condom use among female RNM was observed (OR = 0.34; 95% CI = 0.18-0.62). Training active IDU to promote HIV prevention with behaviorally risky individuals in their networks is feasible, efficacious and sustainable. [ABSTRACT FROM AUTHOR]

Aims Few interventions exist to reduce alcohol and non-injection drug use among people living with HIV/AIDS. This study tested the effects of a coping group intervention for HIV-positive adults with childhood sexual abuse histories on alcohol, cocaine and marijuana use. Design Participants were assigned randomly to the experimental coping group or a time-matched comparison support group. Both interventions were delivered in a group format over 15 weekly 90-minute sessions. Setting and Participants A diverse sample of 247 HIV-positive men and women with childhood sexual abuse were recruited from AIDS service organizations and community health centers in New York City. Measurements Substance use was assessed pre- and post-intervention and every 4 months during a 12-month follow-up period. Using an intent-to-treat analysis, longitudinal changes in substance use by condition were assessed using generalized estimating equations. Findings At baseline, 42% of participants drank alcohol, 26% used cocaine and 26% used marijuana. Relative to participants in the support group, those in the coping group had greater reductions in quantity of alcohol use (Wald χ2(4) = 10.77, P = 0.029) and any cocaine use (Wald χ2(4) = 9.81, P = 0.044) overtime. Conclusions Many HIV patients, particularly those with childhood sexual abuse histories, continue to abuse substances. This group intervention that addressed coping with HIV and sexual trauma was effective in reducing alcohol and cocaine use, with effects sustained at 12-month follow-up. Integrating mental health treatment into HIV prevention may improve outcomes. [ABSTRACT FROM AUTHOR]

Aims Chronic benzodiazepine use is highly prevalent and is associated with a variety of negative health consequences. The present study examined the long-term effectiveness of a tailored patient education intervention on benzodiazepine use. Design A randomized controlled trial was conducted comprising three arms, comparing (i) a single tailored intervention; (ii) a multiple tailored intervention and (iii) a general practitioner letter. The post-test took place after 12 months. Participants Five hundred and eight patients using benzodiazepines were recruited by their general practitioners and assigned randomly to one of the three groups. Intervention Two tailored interventions, the single tailored intervention (patients received one tailored letter) and the multiple tailored intervention (patients received three sequential tailored letters at intervals of 1 month), were compared to a short general practitioner letter that modelled usual care. The tailored interventions not only provided different and more information than the general practitioner letter; they were also personalized and adapted to individual baseline characteristics. The information in both tailored interventions was the same, but in the multiple tailored intervention the information was provided to the participants spread over three occasions. In the multiple tailored intervention, the second and the third tailored letters were based on short and standardized telephone interviews. Measurements Benzodiazepine cessation at post-test was the outcome measure. Findings The results showed that participants receiving the tailored interventions were twice as likely to have quit benzodiazepine use compared to the general practitioner letter. Particularly among participants with the intention to discontinue usage at baseline, both tailored interventions led to high percentages of those who actually discontinued usage (single tailored intervention 51.7%; multiple tailored intervention 35.6%; general practitioner letter 14.5%). Conclusions It was concluded that tailored patient education can be an effective tool for reducing benzodiazepine use, and can be implemented easily. [ABSTRACT FROM AUTHOR]

Aims To assess the long-term efficacy of a fully automated digital multi-media smoking cessation intervention. Design Two-arm randomized control trial (RCT). Setting World Wide Web (WWW) study based in Norway. Participants Subjects ( n = 396) were recruited via internet advertisements and assigned randomly to conditions. Inclusion criteria were willingness to quit smoking and being aged 18 years or older. Intervention The treatment group received the internet- and cell-phone-based Happy Ending intervention. The intervention programme lasted 54 weeks and consisted of more than 400 contacts by e-mail, web-pages, interactive voice response (IVR) and short message service (SMS) technology. The control group received a self-help booklet. Additionally, both groups were offered free nicotine replacement therapy (NRT). Measurements Abstinence was defined as ‘not even a puff of smoke, for the last 7 days’, and assessed by means of internet surveys or telephone interviews. The main outcome was repeated point abstinence at 1, 3, 6 and 12 months following cessation. Findings Participants in the treatment group reported clinically and statistically significantly higher repeated point abstinence rates than control participants [22.3% versus 13.1%; odds ratio (OR) = 1.91, 95% confidence interval (CI): 1.12–3.26, P = 0.02; intent-to-treat). Improved adherence to NRT and a higher level of post-cessation self-efficacy were observed in the treatment group compared with the control group. Conclusions As the first RCT documenting the long-term treatment effects of such an intervention, this study adds to the promise of digital media in supporting behaviour change. [ABSTRACT FROM AUTHOR]

Aims To evaluate the efficacy of central nervous system (CNS) stimulants compared with placebo for the treatment of cocaine dependence. Methods A systematic review and meta-analysis was carried out. Bibliographic databases were searched, reference lists of retrieved studies were hand-searched and the first authors of each study were contacted. All randomized controlled clinical trials (RCCT) comparing the efficacy of any CNS stimulant with placebo in cocaine-dependent patients were included. Quantitative data synthesis was performed for each single CNS stimulant and for all CNS stimulants. Results Nine RCCT met the inclusion criteria. These RCCT included 640 patients and compared five CNS stimulants: mazindol, dextroamphetamine, methylphenidate, modafinil and bupropion with placebo. No CNS stimulant improved study retention [RR = 0.94 (0.81–1.09)] or cocaine use [RR = 0.90 (0.79–1.02)]. An exploratory analysis using indirect estimations of cocaine use showed that the proportion of cocaine-positive urine screens was lower with dexamphetamine than with placebo [RR = 0.73 (0.60–0.90)] and that all CNS stimulants pooled together also suggested a significant decrease of cocaine use [RR = 0.87 (0.77–0.99)]. Data on craving could not be meta-analysed due to heterogeneity, but no RCCT found differences in cocaine craving between active drug and placebo except one, whose outcome favoured dexamphetamine. No serious adverse event (AE) was reported. Average of AE-induced dropouts was low and was greater for CNS stimulants than placebo: 4.4% versus 1.3% ( P = 0.03). Conclusion The main outcomes of this study do not support the use of CNS stimulants for cocaine dependence. Nevertheless, secondary analyses provide some hopeful results that encourage further research with these drugs, mainly with dexamphetamine and modafinil. [ABSTRACT FROM AUTHOR]

Aims Brief alcohol interventions typically have been directed to heavy-drinking patients seeking primary health care and college students. This study examined the efficacy of mailing brief personalized assessment-feedback to interested drinkers recruited from the general public. We hypothesized that problem drinkers would benefit more from the intervention than individuals who were not problem drinkers. Design A two-arm, double-blinded, community-based randomized controlled trial with 6-month follow-up. Setting and participants A screening interview was administered to a stratified random sample of 10 014 Canadians 18 years of age and older (5621 women and 4393 men; M age = 43.3 years, SD = 15.99; response rate = 65.4%). Intervention Current drinkers interested in receiving alcohol self-help materials ( n = 1727) were assigned randomly to receive brief personalized assessment-feedback on male and female population drinking norms by mail, or to a delayed-treatment control group, and were contacted 6 months later (76% retention rate). Measurements Problem drinking status at baseline [using sex-specific Alcohol Use Disorders Identification Test (AUDIT) cut scores], and frequency and quantity of alcohol use at follow-up. Findings Analysis of covariance identified the hypothesized interaction of baseline problem drinking status and treatment condition ( P < 0.01). Among problem drinkers identified at baseline the intervention caused a 10.1% reduction in per-occasion binge drinking compared to controls, whereas there was no difference in binge drinking across conditions for non-problem drinkers. Conclusions The continuum of care for alcohol problems can be broadened by providing brief interventions to interested drinkers in the general population. [ABSTRACT FROM AUTHOR]

Aim The aim of this study is to define the efficacy of dihydrocodeine as an alternative to methadone in the maintenance treatment of opiate dependence. Design A pragmatic open-label randomized controlled study of patients recommended for opiate maintenance treatment to test equivalence of the two treatment options with follow-up continuing for up to 42 months after recruitment. Setting Assessment at either Edinburgh’s Community Drug Problem Service or at two general practitioner practices with specialist drug community psychiatric nurses, then with shared care follow-up. Participants Two hundred and thirty-five subjects (168 male, 67 female) with opiate dependence syndrome were recruited. Subjects selected were suitable for opiate maintenance treatment. Routine treatment was offered throughout. Intervention Patients were randomized to receive either methadone mixture 1 mg/ml or dihydrocodeine, 30 mg or 60 mg tablets. Measurements The primary outcome measure was retention in treatment. Eight secondary outcomes included total illicit opiate use, reported crime, physical health, mental health, injecting drug use, overdoses, selling drugs and being in education or work. Measures were compared over 42 months follow-up. Findings There was no difference in groups for retention in treatment at follow-up and there was improvement in all secondary outcomes from baseline. No significant difference in outcomes was found between randomized groups over time. Compliance with randomized treatment differed by randomized group and was affected by experiences in custody during follow-up. Those randomized to dihydrocodeine were more likely to switch treatments. Conclusions These results, combined with existing clinical experience, provide evidence that dihydrocodeine is a viable alternative to methadone as a maintenance treatment for opiate dependence. Indirect comparisons with other studies show dihydrocodeine (and methadone) to be superior to placebo. [ABSTRACT FROM AUTHOR]

Purpose This paper examines the evidence-based practice (EBP) movement in the context of the developmental status of theory, research and practice on substance use disorders. Scope Hierarchical views that favor randomized controlled trials (RCTs) over other forms of evidence are reviewed, and the benefits and limitations of RCTs are considered as they intersect with contemporary issues in the field. Findings RCTs with lengthy follow-up intervals comprise an important piece of the relevant evidence base, especially for establishing treatment efficacy, but their continued centrality as the ‘gold standard’ of evidence for informing substance abuse practice is questioned. Conclusions Given the status of knowledge, advances in science and practice will probably come from longitudinal studies of the changeable course of addictive behaviors and processes over long time frames and that investigate linkages with treatment selection factors and other surrounding contextual variables that also change through time. Benefits of evidentiary pluralism for advancing an interdisciplinary approach to research and practice are considered. [ABSTRACT FROM AUTHOR]

When reporting on complex behaviour change interventions it is essential to follow published guidance such as that provided by the UK Medical Research Council and journals should require clear descriptions of implementation of the interventions. [ABSTRACT FROM AUTHOR]