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Background and Aims: Long‐acting injectable buprenorphine (LAIB) is a new treatment for opioid use disorder that is generating positive outcomes. Negative effects are typically mild and transient, but can occasionally be serious, resulting in treatment discontinuation/non‐adherence. This paper aims to analyse patients' accounts of how they felt during the first 72 h after initiating LAIB. Methods: Semi‐structured interviews were conducted (June 2021–March 2022) with 26 people (18 males and 8 females) who had started LAIB within the previous 72 h. Participants were recruited from treatment services in England and Wales and were interviewed by telephone using a topic guide. Interviews were audio‐recorded, transcribed and coded. The concepts of embodiment and embodied cognition framed the analyses. Data on participants' substance use, initiation onto LAIB and feelings were tabulated. Next, participants' accounts of how they felt were analysed following the stages of Iterative Categorization. Results: Participants reported complex combinations of changing negative and positive feelings. Bodily experiences included withdrawal symptoms, poor sleep, injection‐site pain/soreness, lethargy and heightened senses inducing nausea ('distressed bodies'), but also enhanced somatic wellbeing, improved sleep, better skin, increased appetite, reduced constipation and heightened senses inducing pleasure ('returning body functions'). Cognitive responses included anxiety, uncertainties and low mood/depression ('the mind in crisis') and improved mood, greater positivity and reduced craving ('feeling psychologically better'). Whereas most negative effects reported are widely recognized, the early benefits of treatment described are less well‐documented and may be an overlooked distinctive feature of LAIB. Conclusions: During the first 72 h after initiating long‐acting injectable buprenorphine, new patients report experiencing a range of interconnected positive and negative short‐term effects. Providing new patients with information about the range and nature of these effects can prepare them for what to expect and help them manage feelings and reduce anxiety. In turn, this may increase medication adherence. [ABSTRACT FROM AUTHOR]

Background and aims: Several reports have documented risk factors for opioid use following treatment discharge, yet few have assessed sex differences, and no study has assessed risk using contemporary machine learning approaches. The goal of the present paper was to inform treatments for opioid use disorder (OUD) by exploring individual factors for each sex that are most strongly associated with opioid use following treatment. Design Secondary analysis of Global Appraisal of Individual Needs (GAIN) database with follow‐ups at 3, 6 and 12 months post‐OUD treatment discharge, exploring demographic, psychological and behavioral variables that predict post‐treatment opioid use. Setting One hundred and thity‐seven treatment sites across the United States. Participants: Adolescents (26.9%), young adults (40.8%) and adults (32.3%) in treatment for OUD. The sample (n = 1,126) was 54.9% male, 66.1% white, 20% Hispanic, 9.8% multi‐race/ethnicity, 2.8% African American and 1.3% other. Measurement Primary outcome was latency to opioid use over 1 year following treatment admission. Results: For women, regularized Cox regression indicated that greater withdrawal symptoms [hazard ratio (HR) = 1.31], younger age (HR = 0.88), prior substance use disorder (SUD) treatment (HR = 1.11) and treatment resistance (HR = 1.11) presented the largest hazard for post‐treatment opioid use, while a random survival forest identified and ranked substance use problems [variable importance (VI) = 0.007], criminal justice involvement (VI = 0.006), younger age (VI = 0.005) and greater withdrawal symptoms (VI = 0.004) as the greatest risk factors. For men, Cox regression indicated greater conduct disorder symptoms (HR = 1.34), younger age (HR = 0.76) and multiple SUDs (HR = 1.27) were most strongly associated with post‐treatment opioid use, while a random survival forests ranked younger age (VI = 0.023), greater conduct disorder symptoms (VI = 0.010), having multiple substance use disorders (VI = 0.010) and criminal justice involvement (VI = 0.006) as the greatest risk factors. Conclusion: Risk factors for relapse to opioid use following opioid use disorder treatment appear to be, for women, greater substance use problems and withdrawal symptoms and, for men, younger age and histories of conduct disorder and multiple substance use disorder. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims There is a growing interest in very low rate [fewer than one cigarette per day (CPD)] and light (one to nine CPD) smokers and in some parts of the world their numbers appear to be increasing. This paper examined changes in prevalence over the past 5 years, cessation patterns, and smoking and demographic characteristics of very low rate, light and moderate-to-heavy (10+ CPD) smokers in England. Design Cross-sectional and longitudinal data from aggregated monthly waves of a household survey: the Smoking Toolkit Study. Setting England. Participants A total of 23 245 smokers interviewed between November 2006 and May 2011 and 4147 who provided data at 6-month follow-up. Measurements We compared the demographic and smoking characteristics between the three groups of smokers at baseline, and the rate of attempts to quit, use of aids to cessation and success of quit attempts at follow-up. Findings Very low rate smoking remained extremely rare (1.9% of smokers in 2006 to 2.8% in 2011), but light smoking became increasingly common (23.9-32.8%). Compared with moderate-to-heavy smokers, very low rate and light smokers were younger, more often female and from a higher socio-economic background. They were more motivated to quit and enjoyed smoking less. During the 6-month follow-up period, light smokers, but not very low rate smokers, were more likely to attempt to quit than moderate-to-heavy smokers. When they tried to quit, very low rate and light smokers used aids to cessation less than moderate-to-heavy smokers but still used them to a substantial degree: 18%, 31% and 44% used over-the-counter nicotine replacement therapy in their most recent quit attempt for the three types of smoker, respectively. Even very low rate smokers had a substantial failure rate: 65% failed in their most recent quit attempt within 6 months. Conclusions Very low rate (fewer than one cigarette per day) and light (one to nine cigarettes per day) smokers in England are at least as motivated to quit as heavier smokers. Although they use cessation medication less than heavier smokers and are more likely to succeed, they still use such medication and fail in quit attempts to a substantial degree. [ABSTRACT FROM AUTHOR]

Background and aims: Evidence for efficacy of brief alcohol interventions (BAIs) is mainly limited to primary care and at‐risk drinkers. The aim was to test the efficacy of a BAI addressing the full spectrum of alcohol use in a general population sample and across alcohol risk groups. Design Two‐parallel‐group randomized controlled trial (allocation ratio 1:1) with post‐baseline assessments at months 3, 6 and 12. Setting: One municipal registry office in Germany responsible for registration, passport and vehicle admission issues. Participants: A total of 1646 proactively recruited 18–64‐year‐old adults with past year alcohol use (56% women, 66% low‐risk drinkers) were randomized to intervention (n = 815) or control (n = 831). Intervention and comparator: The intervention consisted of assessment plus computer‐generated individualized feedback letters at baseline and months 3 and 6. Comparator was assessment only. Measurements Primary outcome was change in the self‐reported number of drinks/week from baseline to 12 months. Changes at 3 and 6 months were secondary outcomes. Moderator was alcohol risk group (low‐risk versus at‐risk drinking) according to the Alcohol Use Disorders Identification Test–Consumption, with scores from 1‐3 (women) and from 1‐4 (men) indicating low‐risk drinking. Findings For the whole sample, significant group differences were observed neither at 12‐month follow‐up [incidence rate ratio (IRR) = 1.01, 95% confidence interval (CI) = 0.87–1.17, Bayes factor (BE) = 0.52] nor at previous assessments (month 3: IRR = 1.01, 95% CI = 0.92–1.12, BE = 0.41; month 6: IRR = 0.93, 95% CI = 0.81–1.07, BE = 1.10). Moderator analyses revealed that low‐risk drinkers were more likely to benefit from BAI only at month 6 than at‐risk drinkers (IRR = 0.77, 95% CI = 0.70–0.86). Conclusions: In a randomized controlled trial, there was no clear evidence for efficacy of a computer‐based brief alcohol intervention in a general population sample, but there was some evidence of medium‐term benefits in the large but understudied group of low‐risk drinkers. [ABSTRACT FROM AUTHOR]

Background and aims: Research from cohorts of individuals with recreational cannabis use indicates that cannabis withdrawal symptoms are reported by more than 40% of those using regularly. Withdrawal symptoms are not well understood in those who use cannabis for medical purposes. Therefore, we prospectively examined the stability of withdrawal symptoms in individuals using cannabis to manage chronic pain. Design, Setting, Participants: Using latent class analysis (LCA) we examined baseline cannabis withdrawal to derive symptom profiles. Then, using latent transition analysis (LTA) we examined the longitudinal course of withdrawal symptoms across the time points. Exploratory analyses examined demographic and clinical characteristics predictive of withdrawal class and transitioning to more or fewer withdrawal symptoms over time. A cohort of 527 adults with chronic pain seeking medical cannabis certification or re‐certification was recruited between February 2014 and June 2015. Participants were recruited from medical cannabis clinic waiting rooms in Michigan, USA. Participants were predominantly white (82%) and 49% identified as male, with an average age of 45.6 years (standard deviation = 12.8). Measurements Baseline, 12‐month and 24‐month assessments of withdrawal symptoms using the Marijuana Withdrawal Checklist–revised. Findings A three‐class LCA model including a mild (41%), moderate (34%) and severe (25%) symptom class parsimoniously represented withdrawal symptoms experienced by people using medical cannabis. Stability of withdrawal symptoms using a three‐class LTA at 12 and 24 months ranged from 0.58 to 0.87, with the most stability in the mild withdrawal class. Younger age predicted greater severity and worsening of withdrawal over time. Conclusions: Adults with chronic pain seeking medical cannabis certification or re‐certification appear to experience mild to severe withdrawal symptoms. Withdrawal symptoms tend to be stable over a 2‐year period, but younger age is predictive of worse symptoms and of an escalating withdrawal trajectory. [ABSTRACT FROM AUTHOR]

Background and aims: Non‐daily smokers (NDS) comprise a large fraction of US smokers. Despite little or no dependence, as typically assessed, intermittent smokers (ITS) have difficulty quitting smoking. A randomized clinical trial comparing the effect of nicotine gum with placebo on quitting smoking in non‐daily smokers did not find an effect on overall abstinence. We undertook an analysis to assess whether using nicotine gum versus placebo when tempted to smoke could reduce incidence of lapses in those situations. Design Within a 6‐week randomized, placebo‐controlled clinical trial of nicotine gum, analyses contrasted the outcome of temptation episodes where gum was or was not used. Setting: Smoking cessation research clinic in Pittsburgh, PA, USA. Participants: A total of 255 adult ITS (131 nicotine gum, 124 placebo) seeking help for smoking cessation. Intervention: Nicotine gum (2 mg) versus placebo for up to 8 weeks, with as‐needed dosing instructions. Measurements Outcome was lapsing in temptation episodes, as reported by participants via ecological momentary assessment (EMA). Propensity scores predicting gum use from situational factors (e.g. mood, social setting, smoking cues) served as a control variable. Findings Participants reported 2713 temptation episodes, 46.0% (1248) of which resulted in smoking (lapsing). There was a significant gum use × active treatment interaction (P = 0.0009). Using nicotine gum decreased the odds of lapsing by 55% compared with using placebo [odds ratio (OR) = 0.45; 0.22–0.94]; when gum was not used, the assigned gum condition made no significant difference (OR = 1.53; 0.78–3.01; Bayes factor = 0.14). The nicotine effect was not reliably different when participants were trying to achieve abstinence versus when trying to maintain abstinence (OR = 0.44; 0.10, 2.03; P = 0.294; Bayes factor = 0.11), for men and women (OR = 1.68; 0.58, 4.87; P = 0.343; Bayes factor = 0.10), or for participants with some or no dependence (OR = 0.88; 0.30, 2.59; P = 0.811; Bayes factor = 0.06). Conclusions: When used in response to temptation to smoke, 2 mg nicotine gum can help to prevent lapses among non‐daily smokers. [ABSTRACT FROM AUTHOR]

Abstract: Aims: To investigate whether smokers prescribed varenicline had lower risks of serious ill‐health during the 4 years following treatment compared with those prescribed nicotine replacement therapy (NRT). Design: Observational cohort study of electronic medical records. Setting: A total of 370 UK general practices sampled from the Clinical Practice Research Datalink. Participants: A total of 126 718 patients aged 18 and over who were issued smoking cessation prescriptions between 1 September 2006 and 31 March 2014. Measurements: Our primary outcome was all‐cause mortality within 2 years of first prescription as indicated by linked Office of National Statistics data. Our secondary outcomes were cause‐specific mortality, all‐cause, cause‐specific hospitalization, primary care diagnosis of myocardial infarction or chronic obstructive pulmonary disease (COPD), body mass index and attendance rate to primary care within 2 years of first prescription. Risk differences and 95% confidence intervals were estimated by multivariable adjusted regression and propensity score matched regression. We used instrumental variable analysis to overcome residual confounding. Findings: People prescribed varenicline were healthier at baseline than those prescribed NRT in almost all characteristics, highlighting the potential for residual confounding. Our instrumental variable analysis results found that people prescribed varenicline had a similar risk of mortality at 2 years [risk difference per 100 patients treated = 0.67, 95% confidence interval (CI) = ‐0.11 to 1.46)] to those prescribed NRT, and there were similar rates of all‐cause hospitalization, incident primary‐care diagnoses of myocardial infarction and COPD. People prescribed varenicline subsequently attended primary care less frequently. Conclusions: Smokers prescribed varenicline in primary care in the United Kingdom do not appear to be less likely to die, be hospitalized or experience a myocardial infarction or chronic obstructive pulmonary disease during the following 2 years compared with smokers prescribed nicotine replacement therapy, but they gain more weight and attend primary care less frequently. [ABSTRACT FROM AUTHOR]

Background and aims Prescription opioid overdose is a leading cause of injury-related morbidity and mortality in the United States. We aimed to identify characteristics associated with clinical severity in emergency department patients with prescription opioid overdose. Design This was a secondary data analysis of adult prescription opioid overdoses from a large prospective cohort of acute overdoses. We examined elements of a typical emergency department evaluation using a multivariable model to determine which characteristics were associated with clinical severity, specifically severe respiratory depression (SRD). Setting This study was conducted at two urban academic emergency departments in New York City, USA. Participants Adult patients who presented with acute prescription opioid overdose between 2009 and 2013 were included in the current study. We analyzed 307 patients (mean age = 44.7, 42% female, 2.0% mortality). Measurements Patient demographics, reported substances ingested, suspected intent for ingesting the substance, vital signs, laboratory data, treatments including antidotes and intubation and outcome of death were recorded by trained research assistants. Intent was categorized into four mutually exclusive categories: suicide, misuse, therapeutic error and undetermined. The primary outcome was SRD, defined as administration of either (a) naloxone or (b) endotracheal intubation (ETI). Findings A total of 109 patients suffered SRD with 90 patients receiving naloxone alone, nine ETI alone and 10 both naloxone and ETI. The most common opioids were oxycodone ( n = 124) and methadone ( n = 116). Mean age was higher in patients with SRD (51.1 versus 41.1, P < 0.001). Opioid misuse was associated with SRD in the multivariable analysis [odds ratio (OR) = 2.07, 95% confidence interval (CI) = 1.21-3.55]. The unadjusted relative risk of SRD was high for fentanyl (83.3% SRD) and lowest for codeine (3.6% SRD). Conclusion In emergency department patients in the United States with prescription opioid overdose, worse clinical severity was associated with opioid misuse, increased with age and was widely variable, depending on the specific opioid medication involved. [ABSTRACT FROM AUTHOR]

Aims To project the impact of scaling-up oral anti-viral therapy and harm reduction on chronic hepatitis C (CHC) prevalence and incidence among people who inject drugs (PWID) in Greece, to estimate the relationship between required treatment levels and expansion of harm reduction programmes to achieve specific targets and to examine whether hepatitis C virus (HCV) elimination among PWID is possible in this high-prevalence setting. Design A dynamic discrete time, stochastic individual-based model was developed to simulate HCV transmission among PWID incorporating the effect of HCV treatment and harm reduction strategies, and allowing for re-infection following treatment. Setting/participants The population of 8300 PWID in Athens Metropolitan area. Measurements Reduction in HCV prevalence and incidence in 2030 compared with 2016. Findings Moderate expansion of HCV treatment (treating 4-8% of PWID/year), with a simultaneous increase of 2%/year in harm reduction coverage (from 44 to 72% coverage over 15 years), was projected to reduce CHC prevalence among PWID in Athens by 46.2-94.8% in 2030, compared with 2016. CHC prevalence would reduce to below 10% within the next 4-5 years if annual HCV treatment numbers were increased up to 16-20% PWID/year. The effect of harm reduction on incidence was more pronounced under lower treatment rates. Conclusions Based on theoretical model projections, scaled-up hepatitis C virus treatment and harm reduction interventions could achieve major reductions in hepatitis C virus incidence and prevalence among people who inject drugs in Athens, Greece by 2030. Chronic hepatitis C could be eliminated in the next 4-5 years by increasing treatment to more than 16% of people who inject drugs per year combined with moderate increases in harm reduction coverage. [ABSTRACT FROM AUTHOR]

Aim To examine the efficacy and safety of (1) midazolam-droperidol versus droperidol and (2) midazolam-droperidol versus olanzapine for methamphetamine-related acute agitation. Design and setting A multi-centre, randomized, double-blind, controlled, clinical trial was conducted in two Australian emergency departments, between October 2014 and September 2015. Participants Three hundred and sixty-one patients, aged 18-65 years, requiring intravenous medication sedation for acute agitation, were enrolled into this study. We report the results of a subgroup of 92 methamphetamine-affected patients. Intervention and comparator Patients were assigned randomly to receive either an intravenous bolus of midazolam 5 mg-droperidol 5 mg combined, droperidol 10 mg or olanzapine 10 mg. Two additional doses were administered, if required: midazolam 5 mg, droperidol 5 mg or olanzapine 5 mg, respectively. Measurements The primary outcome was the proportion of patients sedated adequately at 10 minutes. Odds ratios with 95% confidence intervals (ORs, 95% CI) were estimated. Findings The baseline characteristics of patients in the three groups were similar. At 10 minutes, significantly more patients in the midazolam-droperidol group [29 of 34 (85.3%)] were sedated adequately compared with the droperidol group [14 of 30 (46.7%), OR = 6.63, 95% CI = 2.02-21.78] or with the olanzapine group [14 of 28 (50.0%), OR 5.80, 95% CI = 1.74-19.33]. The number of patients who experienced an adverse event (AE) in the midazolam-droperidol, droperidol and olanzapine groups was seven of 34, two of 30 and six of 28, respectively. The most common AE was oxygen desaturation. Conclusion A midazolam-droperidol combination appears to provide more rapid sedation of patients with methamphetamine-related acute agitation than droperidol or olanzapine alone. [ABSTRACT FROM AUTHOR]

Background and Aims In many countries, conflicting gradients in alcohol consumption and alcohol-associated mortality have been observed. To understand this 'alcohol harm paradox' we analysed the socio-economic gradient in alcohol-associated hospital admissions to test whether it was greater in conditions which were: (1) chronic (associated with long-term drinking) and partially alcohol-attributable, (2) chronic and wholly alcohol-attributable, (3) acute (associated with intoxication) and partially alcohol-attributable and (4) acute and wholly alcohol-attributable. Our aim was to clarify how (1) drinking patterns (e.g. intoxication linked to acute admissions or dependence linked to chronic conditions) and (2) non-alcohol causes (e.g. smoking and poor diet which are risks for partially alcohol-attributable conditions) contribute to the paradox. Design Regression analysis testing the modifying effects of condition-group (1-4 above) and sex on the relationship between area-based deprivation and admissions. Setting England, April 2010-March 2013. Participants A total of 9 239 629 English hospital admissions where a primary or secondary cause was one of 36 alcohol-associated conditions. Measurements Admissions by condition and deciles of Index of Multiple Deprivation (IMD). Socio-economic gradient measured as the relative index of inequality (RII, the slope of a linear regression of IMD on admissions adjusted for overall admission rate). Conditions were categorized by ICD-10 code. Findings A socio-economic gradient in hospitalizations was seen for all conditions, except partially attributable chronic conditions. The gradient was significantly steeper for conditions which were wholly attributable to alcohol and for acute conditions than for conditions partially alcohol-attributable and for chronic conditions. Gradients were steeper for men than for women in cases of wholly alcohol attributable conditions. Conclusions There is a socio-economic gradient in English hospital admission for most alcohol-associated conditions. The greatest inequalities are in conditions associated with alcohol dependence, such as liver disease and mental and behavioural conditions, and in acute conditions, such as alcohol poisoning and assault. Socio-economic differences in harmful drinking patterns (dependence and intoxication) may contribute to the 'alcohol harm paradox'. [ABSTRACT FROM AUTHOR]

Background and Aims It has been suggested that distributing naloxone to people who inject drugs (PWID) will lead to fewer attendances by emergency medical services at opioid-related overdose incidents if peer administration of naloxone was perceived to have resuscitated the overdose victim successfully. This study evaluated the impact of a national naloxone programme (NNP) on ambulance attendance at opioid-related overdose incidents throughout Scotland. Specifically, we aimed to answer the following research questions: is there evidence of an association between ambulance call-outs to opioid-related overdose incidents and the cumulative number of 'take-home naloxone' (THN) kits in issue; and is there evidence of an association between ambulance call-outs to opioid-related overdose incidents in early adopter (pilot) or later adopting (non-pilot) regions and the cumulative number of THN kits issued in those areas? Design Controlled time-series analysis. Setting Scotland, UK, 2008-15. Participants Pre-NNP implementation period for the evaluation was defined as 1 April 2008 to 31 March 2011 and the post-implementation period as 1 April 2011 to 31 March 2015. In total, 3721 ambulance attendances at opioid-related overdose were recorded for the pre-NNP implementation period across 158 weeks (mean 23.6 attendances per week) and 5258 attendances across 212 weeks in the post-implementation period (mean 24.8 attendances per week). Intervention Scotland's NNP; formally implemented on 1 April 2011. Measurements Primary outcome measure was weekly incidence (counts) of call-outs to opioid-related overdoses at national and regional Health Board level. Data were acquired from the Scottish Ambulance Service (SAS). Models were adjusted for opioid replacement therapy using data acquired from the Information Services Division on monthly sums of all dispensed methadone and buprenorphine in the study period. Models were adjusted further for a control group: weekly incidence (counts) of call-outs to heroin-related overdose in the London Borough area acquired from the London Ambulance Service. Findings There was no significant association between SAS call-outs to opioid-related overdose incidents and THN kits in issue for Scotland as a whole (coefficient 0.009, 95% confidence intervals = −0.01, 0.03, P = 0.39). In addition, the magnitude of association between THN kits and SAS call-outs did not differ significantly between pilot and non-pilot regions (interaction test, P = 0.62). Conclusions The supply of take-home naloxone kits through a National Naloxone Programme in Scotland was not associated clearly with a decrease in ambulance attendance at opioid-related overdose incidents in the 4-year period after it was implemented in April 2011. [ABSTRACT FROM AUTHOR]

Background and Aims Global payment and accountable care reform efforts in the United States may connect more individuals with substance use disorders (SUD) to treatment. We tested whether such changes instituted under an Alternative Quality Contract (AQC) model within the Blue Cross Blue Shield of Massachusetts' (BCBSMA) insurer increased care for individuals with SUD. Design Difference-in-differences design comparing enrollees in AQC organizations with a comparison group of enrollees in organizations not participating in the AQC. Setting Massachusetts, USA. Participants BCBSMA enrollees aged 13-64 years from 2006 to 2011 (3 years prior to and after implementation) representing 1 333 534 enrollees and 42 801 SUD service users. Measurements Outcomes were SUD service use and spending and SUD performance metrics. Primary exposures were enrollment into an AQC provider organization and whether the AQC organization did or did not face risk for behavioral health costs. Findings Enrollees in AQC organizations facing behavioral health risk experienced no change in the probability of using SUD services (1.64 versus 1.66%; P = 0.63), SUD spending ($2807 versus $2700; P = 0.34) or total spending ($12 631 versus $12 849; P = 0.53), or SUD performance metrics (identification: 1.73 versus 1.76%, P = 0.57; initiation: 27.86 versus 27.02%, P = 0.50; engagement: 11.19 versus 10.97%, P = 0.79). Enrollees in AQC organizations not at risk for behavioral health spending experienced a small increase in the probability of using SUD services (1.83 versus 1.66%; P = 0.003) and the identification performance metric (1.92 versus 1.76%; P = 0.007) and a reduction in SUD medication use (11.84 versus 14.03%; P = 0.03) and the initiation performance metric (23.76 versus 27.02%; P = 0.005). Conclusions A global payment and accountable care model introduced in Massachusetts, USA (in which a health insurer provided care providers with fixed prepayments to cover most or all of their patients' care during a specified time-period, incentivizing providers to keep their patients healthy and reduce costs) did not lead to sizable changes in substance use disorder service use during the first 3 years following its implementation. [ABSTRACT FROM AUTHOR]

Aims To determine the effectiveness and safety of varenicline in treating tobacco dependence in patients with severe mental illness. Design A systematic reviewand meta-analysis of randomised controlled trials that compared varenicline with a placebo or an alternative intervention for smoking cessation or reduction. Setting Both in- and out-patient settings in any country. Participants Adult patients aged 18 years and over with any type of severe mental illness. The systematic review included eight studies comprising 398 participants. Measures Primary outcome measures were (1) smoking cessation, (2) smoking reduction measured by changes in the number of cigarettes smoked per day and (3) number of psychiatric adverse events, which were collected at the end of treatment. Findings The random-effect pooled estimates from the five studies that reported smoking-related outcomes found that varenicline is statistically superior to placebo in smoking cessation [risk ratios 4.33; 95% confidence interval (CI)=1.96-9.56], and smoking reduction was higher in varenicline groups (mean reduced daily cigarettes was 6.39; 95% CI=2.22-10.56). There is no significant difference regarding neuropsychiatric and other adverse events. Conclusions Varenicline appears to be significantly more effective than placebo in assisting with smoking cessation and reduction in people with severe mental illness. There appears to be no clear evidence that varenicline was associated with an increased risk of neuropsychiatric or other adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Aims To assess the efficacy of topiramate in treating cocaine use disorder (i.e. retention, efficacy, safety and craving reduction) through a systematic review and meta-analysis. Methods We searched six scientific databases from inception to 23 December 2014 with no date limits. Data were reviewed, extracted and analysed systematically. Studies were included if they were peer-reviewed randomized control trials with participants meeting diagnostic criteria for cocaine dependence or cocaine use disorder, with the treatment arm involving topiramate with or without psychosocial intervention, and the control arm involving no intervention or psychosocial intervention with or without placebo. A random-effects meta-analytical model was computed. Results Five studies met inclusion criteria ( n = 518). Topiramate was compared with placebo (four studies) and no medication (one study). In a meta-analysis, we observed no significant differences between topiramate and placebo in improving treatment retention risk ratio (RR) = 0.85; 95% confidence interval (CI) = 0.60-1.22, P = 0.38. However, compared with a placebo, use of topiramate was associated with increased continuous abstinence in two of five studies (RR = 2.43; 95% CI = 1.31-4.53, P = 0.005). No differences were observed in frequency of adverse effects reported between topiramate and placebo (RR = 1.06; 95% CI = 0.91-1.23, P = 0.48). Topiramate was associated significantly ( P < 0.05) with a reduction in craving in only one of five studies. Conclusions Evidence does not currently support the use of topiramate to improve treatment retention for cocaine use disorder, although it may extend cocaine abstinence with a similar risk of adverse events compared with placebo. [ABSTRACT FROM AUTHOR]

Aims To examine the safety and effectiveness of buprenorphine + naloxone sublingual tablets (BUP, as Suboxone®) provided after administration of extended-release injectable naltrexone (XR-NTX, as Vivitrol®) to reduce cocaine use in participants who met DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. Methods This multi-centered, double-blind, placebo-controlled study, conducted under the auspices of the National Drug Abuse Treatment Clinical Trials Network, randomly assigned 302 participants at sites in California, Oregon, Washington, Colorado, Texas, Georgia, Ohio, New York and Washington DC, USA to one of three conditions provided with XR-NTX: 4 mg/day BUP (BUP4, n = 100), 16 mg/day BUP (BUP16, n = 100, or no buprenorphine (placebo; PLB, n = 102). Participants received pharmacotherapy for 8 weeks, with three clinic visits per week. Cognitive behavioral therapy was provided weekly. Follow-up assessments occurred at 1 and 3 months post-intervention. The planned primary outcome was urine drug screen (UDS)-corrected, self-reported cocaine use during the last 4 weeks of treatment. Planned secondary analyses assessed cocaine use by UDS, medication adherence, retention and adverse events. Results No group differences were found between groups for the primary outcome (BUP4 versus PLB, P = 0.262; BUP16 versus PLB, P = 0.185). Longitudinal analysis of UDS data during the evaluation period using generalized linear mixed equations found a statistically significant difference between BUP16 and PLB [ P = 0.022, odds ratio (OR) = 1.71] but not for BUP4 ( P = 0.105, OR = 1.05). No secondary outcome differences across groups were found for adherence, retention or adverse events. Conclusions Buprenorphine + naloxone, used in combination with naltrexone, may be associated with reductions in cocaine use among people who meet DSM-IV criteria for cocaine dependence and past or current opioid dependence or abuse. [ABSTRACT FROM AUTHOR]

Aim To evaluate the effectiveness of an online school-based prevention program for ecstasy (MDMA) and new psychoactive substances (NPS). Design Cluster randomized controlled trial with two groups (intervention and control). Setting Eleven secondary schools in Australia. Participants A total of 1126 students (mean age: 14.9 years). Intervention The internet-based Climate Schools: Ecstasy and Emerging Drugs module uses cartoon storylines to convey information about harmful drug use. It was delivered once weekly, during a 4-week period, during health education classes. Control schools received health education as usual. Measurement Primary outcomes were self-reported intentions to use ecstasy and NPS at 12 months. Secondary outcomes were ecstasy and NPS knowledge and life-time use of ecstasy and NPS. Surveys were administered at baseline, post-intervention and 6 and 12 month post-baseline. Findings At 12 months, the proportion of students likely to use NPS was significantly greater in the control group (1.8%) than the intervention group [0.5%; odds ratio (OR) = 10.17, 95% confidence interval (CI) = 1.31-78.91]. However, students' intentions to use ecstasy did not differ significantly between groups (control = 2.1%, intervention = 1.6%; OR = 5.91, 95% CI = 1.01-34.73). There was a significant group difference in the change from baseline to post-test for NPS knowledge (β = −0.42, 95% CI = −0.62 to −0.21, Cohen's d = 0.77), with controls [mean = 2.78, standard deviation (SD = 1.48] scoring lower than intervention students (mean = 3.85, SD = 1.49). There was also evidence of a significant group difference in ecstasy knowledge at post-test (control: mean = 9.57, SD = 3.31; intervention: mean = 11.57, SD = 3.61; β = −0.54, 95% CI = −0.97 to −0.12, P = 0.01, d = 0.73). Conclusions The Climate Schools: Ecstasy and Emerging Drugs module, a universal online school-based prevention program, appeared to reduce students' intentions to use new psychoactive substances and increased knowledge about ecstasy and new psychoactive substances in the short term. [ABSTRACT FROM AUTHOR]

Background and aims Varenicline increases the likelihood of long-term abstinence following a quit attempt. It has been suggested that (1) part of its benefit arises from 'recruiting into abstinence' smokers who are not able to stop on the target quit date and (2) there may be a higher rate of relapse after treatment. This study addressed these issues. Methods Meta-analyses of data from randomized controlled trials (RCTs) of varenicline identified from the 2012 Cochrane review of nicotine receptor partial agonists for smoking cessation were used to compare the abstinence and relapse patterns on active drug and placebo. Studies of varenicline compared with placebo in adult daily smokers with longest follow-up at either 6 or 12 months and with at least three follow-ups in the first month were included. Biochemically verified abstinence rates at each of six follow-up time-points (2, 3, 4, 12, 24 and 52 weeks) were pooled for studies reporting point prevalence abstinence. Biochemically verified abstinence rates at three follow-up time-periods (9-12 weeks, 9-24 weeks and 9-52 weeks) were pooled for studies reporting continuous abstinence. Random effects meta-analysis was used to estimate pooled proportions with 95% confidence intervals. Results Nineteen RCTs were included. In varenicline-treated participants, point-prevalence abstinence increased by 22 percentage points from week 2 [32%: 95% confidence interval (CI) = 25-40%] to week 12 (54%: 95% CI = 48-61%). The increase was 8 percentage points in the placebo group: 16% (95% CI = 11-21%) to 24% (95% CI = 17-33%). In varenicline-treated participants the relapse from weeks 9-12 to week 52 was 55%: 49% abstinent in weeks 9-12 (95% CI = 45-53%) versus 22% at week 52 (95% CI = 19-25%). In placebo-treated participants it was 53%: 17% (95% CI = 13-25%) in weeks 9-12 versus 8% (95% CI = 6-12%) at week 52. Conclusions Varenicline recruits smokers into abstinence following the target quit date to a greater extent than placebo. Relapse rates from end of treatment to 52 weeks are similar in varenicline- and placebo-treated smokers. [ABSTRACT FROM AUTHOR]

Aims To determine the efficacy of acamprosate and naltrexone in the treatment of those who are alcohol-dependent in reducing lapse/relapse to alcohol consumption and treatment discontinuation, and to examine whether a proportion of the variance in study outcome can be explained by the country in which the trials have taken place. Method A systematic review and meta-analysis of randomized controlled trials published before September 2013 was conducted. The primary outcome measures were the efficacy of acamprosate or naltrexone in reducing lapse/relapse compared to placebo in the treatment of alcohol dependence and treatment discontinuation. Twenty-two randomized controlled trials (RCTs) of the efficacy of acamprosate met inclusion criteria for the meta-analysis, with a total of 2649 participants in the acamprosate group and 2587 in the placebo group. Twenty-seven RCTs of the efficacy of naltrexone met inclusion criteria for the meta-analysis, with a total of 2253 participants in the naltrexone group and 1946 in the placebo group. A random-effects model using a Mantel-Haenszel method was applied to conduct the meta-analysis. Variance in study outcomes was explored using subgroup analysis of Europe versus the rest of the world (ROW). Results The risk of returning to any drinking at 6 months was significantly lower for acamprosate [risk ratio (RR) = 0.83, 95% confidence interval (CI) = 0.78-0.89]. There was little difference in the risk of participants discontinuing treatment for any reason (RR = 0.91, 95% CI = 0.83-1.00) or due to adverse events (RR = 1.30, 95% CI = 0.96-1.75) for the acamprosate compared to placebo groups. The risk of individuals returning to any drinking at approximately 3 months was reduced significantly for the naltrexone group (RR = 0.92, 95% CI = 0.86-1.00), as was the risk of individuals relapsing to heavy drinking at 3 months (RR = 0.85, 95% CI = 0.78-0.93). There was no significant difference between naltrexone and placebo for the risk of individuals discontinuing treatment for any reason (RR = 0.94, 95% CI = 0.84-1.05). There was a significantly greater risk of participants in the naltrexone group discontinuing treatment due to adverse events compared to placebo (RR = 1.72, 95% CI = 1.10-2.70). Subgroup analysis by country (Europe versus ROW) revealed no difference in risk between acamprosate and placebo for the outcomes returning to any drinking at 6 months and discontinuing treatment due to adverse events. For the outcome discontinuation of treatment for any reason, there was a significant difference in RR between Europe and the ROW (χ2 = 11.65, P <0.001) for acamprosate. Acamprosate was associated with a reduction in risk of discontinuing treatment for Europe (RR = 0.86, 95% CI = 0.79-0.95), but an increase in risk of discontinuing treatment for ROW (RR = 1.23, 95% CI = 1.03-1.48). Conclusions Both acamprosate and naltrexone appear to reduce the risk of individuals returning to drinking alcohol in those who are alcohol-dependent. The country in which a randomized control trial (RCT) for the efficacy of acamprosate and naltrexone is completed does not appear to explain the variance in trial outcomes for returning to drinking alcohol or discontinuing drinking due to adverse effects. However, the country in which the RCT of acamprosate are completed may be important for explaining the variance between studies for the outcome 'discontinuing treatment for any reason'. [ABSTRACT FROM AUTHOR]

Background and Aims Modelling the population impact and cost-effectiveness of smoking cessation aids is limited by lack of knowledge about how the use of aids changes across quit attempts. Here we test whether the quit method used in a previous attempt influences (i) future decisions to quit and/or (ii) treatment/s used during subsequent attempts. Design and Setting Data came from the Smoking Toolkit Study, a United Kingdom national household survey. Participants and Measures Smokers ( n = 5489) who completed a baseline and 6-month follow-up questionnaire. Respondents were asked what treatment/s, grouped as: prescription medication/s [bupropion, varenicline or nicotine replacement therapy (NRT)], over-the-counter NRT or unaided that they had used in their most recent quit attempt (at baseline), and any use of treatment/s for a quit attempt in the last 3 months at follow-up. Results Smokers who had tried to quit at baseline were more likely to report having tried to quit again prior to follow-up [all odds ratios ≥ 2.19 relative to no attempt at baseline, P < 0.001]. Smokers who tried to quit using pharmacological aids were more likely to try to quit again at follow-up (all ORs ≥ 2.19 relative to no attempt at baseline, P < 0.001). Smokers tended to re-try aids used in baseline attempts in future attempts (all ORs ≥ 1.48 relative to no attempt at baseline, P < 0.01). Conclusions Smokers who have tried to quit in the past year are more likely to try to quit again within 6 months regardless of whether they used a pharmacological aid, and they are more likely to re-try aids they had used previously. [ABSTRACT FROM AUTHOR]

Aims To assess the relations of menthol cigarette use with measures of cessation success in a large comparative effectiveness trial ( CET). Design Participants were randomized to one of six medication treatment conditions in a randomized double-blind, placebo-controlled clinical trial. All participants received six individual counseling sessions. Setting Community-based smokers in two communities in Wisconsin, USA. Participants A total of 1504 adult smokers who smoked at least 10 cigarettes per day during the past 6 months and reported being motivated to quit smoking. The analysis sample comprised 1439 participants: 814 white non-menthol smokers, 439 white menthol smokers and 186 African American ( AA) menthol smokers. There were too few AA non-menthol smokers ( n = 16) to be included in the analyses. Interventions Nicotine lozenge, nicotine patch, bupropion sustained release, nicotine patch + nicotine lozenge, bupropion + nicotine lozenge and placebo. Measurements Biochemically confirmed 7-day point-prevalence abstinence assessed at 4, 8 and 26 weeks post-quit. Findings In longitudinal abstinence analyses (generalized estimating equations) controlling for cessation treatment, menthol smoking was associated with reduced likelihood of smoking cessation success relative to non-menthol smoking [model-based estimates of abstinence = 31 versus 38%, respectively; odds ratio ( OR) = 0.71, 95% confidence interval ( CI) = 0.59, 0.86]. In addition, among menthol smokers, AA women were at especially high risk of cessation failure relative to white women (estimated abstinence = 17 versus 35%, respectively; OR = 2.63, 95% CI = 1.75, 3.96; estimated abstinence rates for AA males and white males were both 30%, OR = 1.06, 95% CI = 0.60, 1.66). Conclusion In the United States, smoking menthol cigarettes appears to be associated with reduced cessation success compared with non-menthol smoking, especially in African American females. [ABSTRACT FROM AUTHOR]

Aims To examine the efficacy of a brief intervention delivered by a therapist ( TBI) or a computer ( CBI) in preventing cannabis use among adolescents in urban primary care clinics. Design A randomized controlled trial comparing: CBI and TBI versus control. Setting Urban primary care clinics in the United States. Participants Research staff recruited 714 adolescents (aged 12-18 years) who reported no life-time cannabis use on a screening survey for this study, which included a baseline survey, randomization (stratified by gender and grade) to conditions (control; CBI; TBI) and 3-, 6- and 12-month assessments. Measurements Using an intent-to-treat approach, primary outcomes were cannabis use (any, frequency); secondary outcomes included frequency of other drug use, severity of alcohol use and frequency of delinquency (among 85% completing follow-ups). Findings Compared with controls, CBI participants had significantly lower rates of any cannabis use over 12 months (24.16%, 16.82%, respectively, P < 0.05), frequency of cannabis use at 3 and 6 months ( P < 0.05) and other drug use at 3 months ( P < 0.01). Compared with controls, TBI participants did not differ in cannabis use or frequency, but had significantly less other drug use at 3 months ( P < 0.05), alcohol use at 6 months ( P < 0.01) and delinquency at 3 months ( P < 0.01). Conclusions Among adolescents in urban primary care in the United States, a computer brief intervention appeared to prevent and reduce cannabis use. Both computer and therapist delivered brief interventions appeared to have small effects in reducing other risk behaviors, but these dissipated over time. [ABSTRACT FROM AUTHOR]

Aims To test aripiprazole for efficacy in decreasing use in methamphetamine-dependent adults, compared to placebo. Design Participants were randomized to receive 12 weeks of aripiprazole or placebo, with a 3-month follow-up and a platform of weekly 30-minute substance abuse counseling. Setting The trial was conducted from January 2009 to March 2012 at the San Francisco Department of Public Health. Participants Ninety actively using, methamphetamine-dependent, sexually active adults were recruited from community venues. Measurements The primary outcome was regression estimated reductions in weekly methamphetamine-positive urines. Secondary outcomes were study medication adherence [by self-report and medication event monitoring systems ( MEMS)], sexual risk behavior and abstinence from methamphetamine. Findings Participant mean age was 38.7 years, 87.8% were male, 50.0% white, 18.9% African American, and 16.7% Latino. Eighty-three per cent of follow-up visits and final visits were completed. By intent-to-treat, participants assigned to aripiprazole had similar reductions in methamphetamine-positive urines as participants assigned to placebo [risk ratio ( RR) 0.88, 95% confidence interval ( CI): 0.66-1.19, P = 0.41]. Urine positivity declined from 73% (33 of 45 participants) to 45% (18 of 40) in the placebo arm and from 77% (34 of 44) to 44% (20 of 35) in the aripiprazole arm. Adherence by MEMS and self-report was 42 and 74%, respectively, with no significant difference between arms ( MEMS P = 0.31; self-report P = 0.17). Most sexual risk behaviors declined similarly among participants in both arms (all P > 0.05). There were no serious adverse events related to study drug, although participants randomized to aripiprazole reported more akathisia, fatigue and drowsiness ( P < 0.05). Conclusion Compared with placebo, aripiprazole did not reduce methamphetamine use significantly among actively using, dependent adults. [ABSTRACT FROM AUTHOR]

Aim To evaluate the population effectiveness of stop-smoking medications while accounting for potential recall bias by controlling for quit attempt recency. Design Prospective cohort survey. Setting United Kingdom, Canada, Australia and the United States. Participants A total of 7436 adult smokers (18+ years) selected via random digit dialling and interviewed as part of the International Tobacco Control Four Country Survey ( ITC-4) between 2002 and 2009. Primary analyses utilized the subset of respondents who participated in 2006 or later ( n = 2550). Measurements Continuous abstinence from smoking for 1 month/6 months. Findings Among participants who recalled making a quit attempt within 1 month of interview, those who reported using varenicline, bupropion or nicotine patch were more likely to maintain 6-month continuous abstinence from smoking compared to those who attempted to quit without medication [adjusted odds ratio ( OR) 5.84, 95% confidence interval ( CI) (2.12-16.12), 3.94 (0.87-17.80), 4.09 (1.72-9.74), respectively]; there were no clear effects for oral NRT use. Those who did not use any medication when attempting to quit tended to be younger, to be racial/ethnic minorities, to have lower incomes and to believe that medications do not make quitting easier. Conclusions Consistent with evidence from randomized controlled trials, smokers in the United Kingdom, Canada, Australia and the United States are more likely to succeed in quit attempts if they use varenicline, bupropion or nicotine patch. Previous population studies that failed to find an effect failed to control adequately for important sources of bias. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To review the transparency of reports of behavioral interventions for pathological gambling and other gambling-related disorders. Methods We used the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) Statement to develop the 59-question Adapted TREND Questionnaire (ATQ). Each ATQ question corresponds to a transparency guideline and asks how clearly a study reports its objectives, research design, analytical methods and conclusions. A subset of 23 ATQ questions is considered particularly important. We searched PubMed, PsychINFO and Web of Science to identify experimental evaluations published between 2000 and 2011 aiming to reduce problem gambling behaviors or decrease problems caused by gambling. Twenty-six English-language reports met the inclusion criteria and were reviewed by three abstractors using the ATQ. Results The average report adhered to 38.4 (65.1%) of the 59 ATQ transparency guidelines. Each of the 59 ATQ questions received positive responses from an average of 16.9 (63.8%) of the reports. The subset of 23 particularly relevant questions received an average of 15.3 (66.5%) positive responses. Thirty-two of 59 (54%) ATQ questions were answered positively by 75% or more of the study reports, while 12 (20.3%) received positive responses by 25% or fewer. Publication year did not affect these findings. Conclusions Gambling intervention reports need to improve their transparency by adhering to currently neglected and particularly relevant guidelines. Among them are recommendations for comparing study participants who are lost to follow-up and those who are retained, comparing study participants with the target population, describing methods used to minimize potential bias due to group assignment, and reporting adverse events or unintended effects. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To examine the association of person-specific trajectories of withdrawal symptoms of urge-to-smoke, negative affect, physical symptoms and hunger during the first 7 days after smoking cessation with abstinence at end of treatment (EOT) and at 6 months. Design Hierarchical linear modeling (HLM) was used to model person-specific trajectory parameters (level, slope, curvature and volatility) for withdrawal symptoms. Setting University-based smoking cessation trials. Participants Treatment-seeking smokers in clinical trials of transdermal nicotine versus nicotine spray ( n = 514) and bupropion versus placebo ( n = 421). Measurements Self-reported withdrawal symptoms for 7 days after the planned quit date, and 7-day point prevalence and continuous abstinence at EOT and 6 months. Findings In regressions that included trajectory parameters for one group of withdrawal symptoms, both urge-to-smoke and negative affect were predictive of abstinence while physical symptoms and hunger were generally not predictive. In stepwise regressions that included the complete set of trajectory parameters across withdrawal symptoms (for urge-to-smoke, negative affect, physical symptoms and hunger), with a single exception only the trajectory parameters for urge-to-smoke were predictive. Area under the receiver operator characteristic curve was 0.594 for covariates alone, and 0.670 for covariates plus urge-to-smoke trajectory parameters. Conclusions Among a number of different withdrawal symptoms (urge-to-smoke, negative affect, physical symptoms and hunger) urge-to-smoke trajectory parameters (level, slope and volatility) over the first 7 days of smoking cessation show the strongest prediction of both short- and long-term relapse. Other withdrawal symptoms increase the predictive ability by negligible amounts. [ABSTRACT FROM AUTHOR]