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Background and aims Screening, Brief Intervention and Referral to Treatment (SBIRT) programs have been implemented widely in medical settings, with little attention focused on how well providers adhere to evidence-based service delivery in everyday practice. The purposes of this paper were to: (1) introduce a flexible, relatively simple methodology, the SBIRT Checklist for Observation in Real-time (SCORe), to assess adherence to evidence-based practice and provide preliminary evidence supporting its criterion validity; and (2) illustrate the feasibility and potential utility of the SCORe by analyzing observations of providers within four large-scale SBIRT programs in the United States. Methods Eighteen potential adherence judges were trained to recognize SBIRT service elements presented in realistic taped portrayals constructed to serve as criterion coding standards. Across the four SBIRT programs, 76 providers were observed performing 388 services in three types of medical settings; emergency departments ( n = 10), hospital out-patient/ambulatory clinics ( n = 16) and hospital in-patient settings ( n = 5). Results Across two exercises, trainees identified 81% of screening and 75% of brief intervention (BI) elements correctly; for the six FRAMES components (Feedback, Responsibility, Advice, Menu of options, Empathy, Self-efficacy), agreement ranged from 69% to 91%. Across programs, 56% of screening, 54% of brief intervention (BI) (81% of FRAMES) and 53% of referral to treatment elements were observed. Programs differed significantly in adherence [screening, P = 0.024; BI, P < 0.001; FRAMES, P < 0.001; referral to treatment (RT), P < 0.001]; medical setting differences were minimal. Conclusions The Screening, Brief Intervention and Referral to Treatment Checklist for Observation in Real-time provides a flexible method for assessing adherence to evidence-based Screening, Brief Intervention and Referral to Treatment service protocols. Preliminary evidence supports the criterion validity, feasibility and potential utility of the Screening, Brief Intervention and Referral to Treatment Checklist for Observation in Real-time protocol. [ABSTRACT FROM AUTHOR]

Aim: To test the association of alcohol consumption with total and cause‐specific mortality risk. Design Prospective observational multi‐centre population‐based study. Setting: Sixteen cohorts (15 from Europe) in the MOnica Risk, Genetics, Archiving and Monograph (MORGAM) Project. Participants: A total of 142 960 individuals (mean age 50 ± 13 years, 53.9% men). Measurements Average alcohol intake by food frequency questionnaire, total and cause‐specific mortality. Findings In comparison with life‐time abstainers, consumption of alcohol less than 10 g/day was associated with an average 11% [95% confidence interval (CI) = 7–14%] reduction in the risk of total mortality, while intake > 20 g/day was associated with a 13% (95% CI = 7–20%) increase in the risk of total mortality. Comparable findings were observed for cardiovascular (CV) deaths. With regard to cancer, drinking up to 10 g/day was not associated with either mortality risk reduction or increase, while alcohol intake > 20 g/day was associated with a 22% (95% CI = 10–35%) increased risk of mortality. The association of alcohol with fatal outcomes was similar in men and women, differed somewhat between countries and was more apparent in individuals preferring wine, suggesting that benefits may not be due to ethanol but other ingredients. Mediation analysis showed that high‐density lipoprotein cholesterol explained 2.9 and 18.7% of the association between low alcohol intake and total as well as CV mortality, respectively. Conclusions: In comparison with life‐time abstainers, consuming less than one drink per day (nadir at 5 g/day) was associated with a reduced risk of total, cardiovascular and other causes mortality, except cancer. Intake of more than two drinks per day was associated with an increased risk of total, cardiovascular and especially cancer mortality. [ABSTRACT FROM AUTHOR]

Aims: To test the efficacy of a brief intervention to reduce alcohol or drug use and to promote use of addiction services among patients seeking mental health treatment. Design and setting: A multi‐centre, longitudinal, two‐group randomized controlled trial with randomization within each of two mental health treatment systems located in Ventura County and Los Angeles County in California, USA. Participants: A total of 718 patients (49.2% female) aged 18 and older with a mental health diagnosis and either a heavy drinking day or any use of cannabis or stimulants in the past 90 days. Intervention and comparator: A motivation‐based brief intervention with personalized feedback (screening, brief intervention and referral to treatment (SBIRT) condition) (n = 354) or a health education session (control condition) (n = 364). Measurements Primary outcomes included frequency of heavy drinking days, days of cannabis use and days of stimulant use at the primary end‐point 3 months post‐baseline. Secondary outcomes included frequency and abstinence from substance use out to a 12‐month follow‐up and the use of addiction treatment services. Findings Participants in the SBIRT condition had fewer heavy drinking days [odds ratio (OR) = 0.53; 95% credible interval (CrI) = 0.48–0.6] and fewer days of stimulant use (OR = 0.58; 95% CrI = 0.50–0.66) at the 3‐month follow‐up compared with participants in the health education condition. Participants in the SBIRT condition did not comparatively reduce days of cannabis use at the 3‐month follow‐up (OR = 0.93; 95% CrI = 0.85–1.01). Secondary outcomes indicated sustained effects of SBIRT on reducing the frequency of heavy drinking days and days of stimulant use. No effects were observed on abstinence rates or use of addiction treatment services. Conclusions: Screening and brief intervention for unhealthy alcohol and drug use in mental health treatment settings were effective at reducing the frequency of heavy drinking and stimulant use. [ABSTRACT FROM AUTHOR]

Background and Aims: Guidelines recommend the 5As model of brief intervention for providing smoking cessation support in clinical settings. This study assessed patient and hospital characteristics associated with self‐reported receipt of the 5As (ask, advise, assess, assist and arrange). Design Multi‐center cross‐sectional study. Setting and participants: Adult inpatients (n = 1047) were randomly selected from 13 hospitals in the Barcelona province of Spain in 2014–2015. Measurements We explored participants' receipt of the 5As through a questionnaire. Given the progressiveness of the 5As, we recoded the fulfillment of the intervention as: A0: no intervention; A1: ask; A2: ask and advise; A3: A2 and assess; A4: A3 and assist; and A5: A4 and arrange a follow‐up. We explored patient (e.g. age, sex, comorbidities) and hospital (e.g. type of hospital, unit) characteristics. We adjusted multi‐level robust Poisson regression models to estimate the adjusted prevalence ratios (aPR) of the association between the recoded 5As intervention received. Findings A total of 60.4% (n = 624) of patients had been asked (A1) about their smoking status. Among smokers, 46.5% (n = 90) were advised (A2), 26.6% (n = 48) assessed (A3) and 4.6% (n = 10) received all the components of the 5As (A5). Middle‐aged smokers [aPR = 3.63; 95% confidence interval (CI) = 1.69–7.79] with a respiratory disease (aPR = 2.19; 95% CI = 1.11–4.34) were most likely to have been asked, advised and assessed (A3). The cessation intervention was most frequently performed by physicians. Conclusions: In the Barcelona province of Spain, it appears that fewer than half of hospitalized patients who smoke were advised to quit and few received the full 'five As' brief intervention for smoking cessation. [ABSTRACT FROM AUTHOR]

Abstract: Background and Aims: Extended‐release naltrexone (XR‐NTX), a μ‐opioid receptor antagonist for prevention of relapse to opioid dependence, has demonstrated efficacy compared with placebo and comparative effectiveness with buprenorphine–naloxone. We report outcomes for XR‐NTX in Vivitrol's Cost and Treatment Outcomes Registry. Design: Observational, open‐label, single‐arm, multi‐center registry assessing baseline characteristics and clinical and health‐related quality‐of‐life outcomes associated with XR‐NTX treatment in clinical practice. Setting: 32 US treatment centers from 2011 to 2013. Participants: Patients with opioid dependence who were prescribed XR‐NTX treatment and then enrolled into the registry. Measurements: Monthly visits were evaluated for the full population and for patient ubgroups retrospectively, defined by injection number, focusing on the period between baseline and month 6 (1‐, 2/3‐ or 6‐XR‐NTX). Findings: Of 403 enrolled patients, 395 were analyzed. Most patients (n = 349) received out‐patient care. On average, patients received five injections (median = 3; range = 1–25). The median number of injections administered within 6 months was higher in patients who at baseline were employed (three versus two unemployed, P = 0.02) or had private insurance (five versus two self‐payment, P = 0.005; versus two state‐funded, P < 0.001). The 1‐, 2/3‐ and 6‐XR‐NTX groups had 132, 152 and 111 patients, respectively. At baseline, the 6‐XR‐NTX patients were more likely to meet normal/minimal mental illness criteria and attend school and less likely to report recent drug use. Within 6 months, the 6‐XR‐NTX group demonstrated improvements in employment, mental health and psychosocial functioning, and decreases in opioid craving, drug use and drug‐related behavior. Conclusions: Among opioid‐dependent people receiving XR‐NTX treatment, better mental health, higher education and lower recent drug use at baseline are associated with greater treatment duration; in turn, longer treatment duration is associated with lower relapse rates and improved outcomes generally. [ABSTRACT FROM AUTHOR]

Abstract: Background and aims: Emergency department (ED) alcohol‐related presentation data are not routinely collected in Australia and New Zealand. It is likely that previous research has underestimated the numbers of patients presenting with alcohol‐related conditions. This study aimed to quantify the level of alcohol harm presenting to EDs in Australia and New Zealand [Correction added on 23 Jan 2018, after first online publication: The ‘aims’ section was missing and is updated in this version]. Design: Multi‐centre, prospective study. Patients were screened prospectively for alcohol‐related presentations during a 7‐day period in December 2014. Part 1 involved screening to determine alcohol‐positive ED presentations and data collection of patient demographic and clinical information. Part 2 involved a consent‐based survey conducted with patients aged ≥ 14 years to perform Alcohol Use Disorders Identification Test (AUDIT) scores. Setting: Eight EDs in Australia and New Zealand, representing differing hospital role delineations. Participants: A total of 8652 patients aged ≥ 14 years attended and 8435 (97.5%) were screened. Measurements: The main outcome measure was the proportion of patients who had an alcohol‐related presentation termed ‘alcohol‐positive’, using pre‐defined criteria. It included injuries, intoxication, medical conditions and injuries caused by an alcohol‐affected third party. Secondary outcomes included demographic and clinical information, the type of alcohol‐related presentations and AUDIT scores. Findings: A total of 801 [9.5%; 95% confidence interval (CI) = 8.9–10.1%] presentations were identified as alcohol‐positive, ranging between 4.9 and 15.2% throughout sites. Compared with alcohol‐negative patients, alcohol‐positive patients were more likely to be male [odds ratio (OR) = 1.90, 95% CI = 1.63–2.21], younger (median age 37 versus 46 years, P < 0.0001), arrive by ambulance (OR = 1.94, 95% CI = 1.68–2.25) or police/correctional vehicle (OR = 4.56, 95% CI = 3.05–6.81) and require immediate treatment (OR = 3.20, 95% CI = 2.03–05.06). The median AUDIT score was 16 (interquartile range = 10–24). Conclusions: Almost one in 10 presentations to emergency departments in Australia and New Zealand are alcohol related. [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 study the effectiveness of intensive counselling by a practice nurse (PN) versus brief advice by a general practitioner (GP), each combined with pharmacotherapy, for 6 months' tobacco abstinence (primary outcome). Secondary outcomes included 12-month abstinence, medication adherence and incremental costs per life-year gained. Design A multi-site ( n = 10), two-group, parallel, pragmatic randomized controlled trial. Setting A network of primary health-care centres in the Netherlands. Participants A total of 295 adult daily smokers (mean age = 48 years; mean cigarettes/day = 19). Intervention and comparator Patients were randomized to receive individual counselling by a practice nurse (PN) ( n = 149) or brief advice by a general practitioner (GP) (146). All patients received 12 weeks of open-label varenicline. Measurements The primary outcome was prolonged biochemically validated abstinence from weeks 9 to 26 after treatment initiation. Secondary outcomes included abstinence from weeks 9 to 52, good dosing adherence (> 80% days taken) and incremental costs per life-year gained. Findings Abstinence rates in the PN versus GP groups were 32.2% ( n = 48) versus 39.0% [ n = 57; odds ratio (OR) = 0.71; 95% confidence interval (CI) = 0.44-1.16] from weeks 9 to 26 and 25.5% ( n = 38) versus 28.8% ( n = 42; OR = 0.84, 95% CI = 0.50-1.43) from weeks 9 to 52, respectively. Values of the Bayes factor indicated that the PN and GP were equally effective. Good dosing adherence was significantly lower in the PN (45.5%, n = 56/123) than in the GP group (62.0%, n = 75/121; OR = 0.45, 95% CI = 0.26-0.77), and the incremental costs per life-year gained were -€416.10. Conclusions Among people seeking help to stop smoking from their general practice, one-off brief advice from a general practitioner appears to be as effective as several sessions of behavioural support from a practice nurse when smoking cessation medication is provided. [ABSTRACT FROM AUTHOR]

Background and aims Anhedonia-a transdiagnostic psychopathological trait indicative of inability to experience pleasure-could lead to and result from adolescent marijuana use, yet this notion has not been tested. This study aimed to estimate the association of: (1) anhedonia at age 14 with rate of change in marijuana use over an 18-month follow-up, and (2) marijuana use at age 14 with rate of change in anhedonia over follow-up. Secondary aims were to test whether gender, baseline marijuana use history and peer marijuana use moderated these associations. Design Observational longitudinal cohort repeated-measures design, with baseline (age 14 years), 6-month, 12-month and 18-month follow-up assessments. Settings Ten public high schools in Los Angeles, CA, USA, 2013-15. Participants Students [ n = 3394; 53.5% female, mean (standard deviation) age at baseline = 14.1 (0.42)]. Measurements Self-report level of anhedonia on the Snaith-Hamilton Pleasure Scale and frequency of marijuana use in the past 30 days. Findings Parallel process latent growth curve models adjusting for confounders showed that baseline anhedonia level was associated positively with the rate of increase in marijuana use frequency across follow-ups [β, 95% confidence interval (CI) = 0.115 (0.022, 0.252), P = 0.03]. Baseline marijuana use frequency was not related significantly to the rate of change in anhedonia across follow-ups [β, 95% CI = −0.015 (−0.350, 0.321), P = 0.93]. The association of baseline anhedonia with faster marijuana use escalation was amplified among adolescents with (versus without) friends who used marijuana at baseline [β, 95% CI = 0.179 (0.043, 0.334) versus 0.064 (−0.071, 0.187), interaction P = 0.04], but did not differ by gender or baseline ever marijuana use. Conclusions In mid-adolescence, anhedonia is associated with subsequent marijuana use escalation, but marijuana use escalation does not appear to be associated with subsequent anhedonia. [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 Recreational marijuana legalization (RML) went into effect in Oregon in July 2015. RML is expected to influence marijuana use by adolescents and young adults in particular, and by those with a propensity for substance use. We sought to quantify changes in rates of marijuana use among college students in Oregon from pre- to post-RML relative to college students in other states across the same time period. Design Repeated cross-sectional survey data from the 2012-16 administrations of the Healthy Minds Study. Setting Seven 4-year universities in the United States. Participants There were 10 924 undergraduate participants. One large public Oregon university participated in 2014 and 2016 ( n = 588 and 1115, respectively); six universities in US states where recreational marijuana use was illegal participated both in 2016 and at least once between 2012 and 2015. Measurements Self-reported marijuana use in the past 30 days (yes/no) was regressed on time (pre/post 2015), exposure to RML (i.e. Oregon students in 2016) and covariates using mixed-effects logistic regression. Moderation of RML effects by recent heavy alcohol use was examined. Findings Rates of marijuana use increased from pre- to post-2015 at six of the seven universities, a trend that was significant overall. Increases in rates of marijuana use were significantly greater in Oregon than in comparison institutions, but only among students reporting recent heavy alcohol use. Conclusions Rates of Oregon college students' marijuana use increased (relative to that of students in other states) following recreational marijuana legislation in 2015, but only for those who reported recent heavy use of alcohol. Such alcohol misuse may be a proxy for vulnerabilities to substance use or lack of prohibitions (e.g. cultural) against it. [ABSTRACT FROM AUTHOR]

Background and aims Among US high school students, alcohol consumption and cigarette smoking are associated with numerous concurrent and future harms. We tested whether multiple elementary school personality dispositions to behave impulsively can predict these addictive behaviors invariably across gender and race. Design and Setting This longitudinal design involved testing whether individual differences on impulsigenic traits in elementary school predicted drinking and smoking 4 years later in high school in 23 public schools in Kentucky, USA. Participants A total of 1897 youth, mean age 10.33 at wave 1, drawn from urban, rural and suburban backgrounds. Measurements Drinking and smoking frequency were assessed by single-item questions. The key predictors were impulsigenic traits measured with the UPPS-P Child Version impulsive behavior scale. Important covariates included were pubertal status, depression, negative affect and positive affect; each was assessed by self-report. Findings Three personality traits measured in 5th grade, each representing different dispositions to engage in impulsive behavior, predicted drinking and smoking in 9th grade above and beyond other risk factors and 5th grade drinking and smoking. Specifically, urgency ( b = 0.10, 0.13), sensation-seeking ( b = 0.13, 0.07) and low conscientiousness ( b = 0.14, 0.11) each uniquely predicted both high school drinking and smoking, respectively. There was no evidence that any trait predicted either outcome more strongly than the other traits, nor was there evidence that predictive results varied by gender or race. Conclusions Three personality traits (urgency, sensation-seeking and low conscientiousness), when measured in 11-year-old children, predict those children's drinking and smoking behavior individually at age 15. The effects are invariant across gender and race. [ABSTRACT FROM AUTHOR]

Aims To determine (i) whether Australian adolescents' exposure to television alcohol advertisements changed between 1999 and 2011 and (ii) examine the association between television alcohol advertising and adolescent drinking behaviours. Design Cross-sectional surveys conducted every 3 years between 1999 and 2011. Analyses examined associations between advertising exposures and reported drinking. Setting Five Australian major cities. Participants Students aged 12-17 years participating in a triennial nationally representative school-based survey residing in the television advertising markets associated with the major cities (sample size range per survey: 12 644-16 004). Measurements Outcome measures were: drinking in the past month, past week and past-week risky drinking (5+ drinks on a day). The key predictor variable was past-month adolescent-directed alcohol advertising Targeted Rating Points (TRPs, a measure of television advertising exposure). Control measures included student-level characteristics, government alcohol-control advertising TRPs, road safety (drink-driving) TRPs and time of survey. Findings Average monthly adolescent alcohol TRPs increased between 1999 (mean = 2371) to 2005 (mean = 2679) ( P < 0.01) then decreased between 2005 and 2011: (mean = 880) ( P < 0.01). Multi-level logistic regression analyses that adjusted for survey timing, student level factors and alcohol-control advertising variables showed a significant association between past-month alcohol TRPs and past-month drinking [odds ratio (OR) = 1.11, 95% confidence interval (CI) = 1.07-1.15), past-week drinking (OR = 1.10, 95% CI = 1.06-1.14) and past-week risky drinking (OR = 1.15, 95% CI = 1.09-1.22). Past-week risky drinking was associated inversely with road safety TRPs (OR = 0.69, 95% CI = 0.49-0.98). Conclusions While Australian adolescents' exposure to alcohol advertising on television reduced between 1999 and 2011, higher levels of past-month television alcohol advertising were associated with an increased likelihood of adolescents' drinking. The reduction in television alcohol advertising in Australia in the late 2000s may have played a part in reducing adolescents' drinking prevalence. [ABSTRACT FROM AUTHOR]

Background and Aims Criminal justice-involved individuals are highly susceptible to opioid relapse and overdose-related deaths. In a recent randomized trial, we demonstrated the effectiveness of extended-release naltrexone (XR-NTX; Vivitrol®) in preventing opioid relapse among criminal justice-involved US adults with a history of opioid use disorder. The cost of XR-NTX may be a significant barrier to adoption. Thus, it is important to account for improved quality of life and downstream cost-offsets. Our aims were to (1) estimate the incremental cost per quality-adjusted life-year (QALY) gained for XR-NTX versus treatment as usual (TAU) and evaluate it relative to generally accepted value thresholds; and (2) estimate the incremental cost per additional year of opioid abstinence. Design Economic evaluation of the aforementioned trial from the taxpayer perspective. Participants were randomized to 25 weeks of XR-NTX injections or TAU; follow-up occurred at 52 and 78 weeks. Setting Five study sites in the US Northeast corridor. Participants A total of 308 participants were randomized to XR-NTX ( n = 153) or TAU ( n = 155). Measurements Incremental costs relative to incremental economic and clinical effectiveness measures, QALYs and abstinent years, respectively. Findings The 25-week cost per QALY and abstinent-year figures were $162 150 and $46 329, respectively. The 78-week figures were $76 400/QALY and $16 371/abstinent year. At 25 weeks, we can be 10% certain that XR-NTX is cost-effective at a value threshold of $100 000/QALY and 62% certain at $200 000/QALY. At 78 weeks, the cost-effectiveness probabilities are 59% at $100 000/QALY and 76% at $200 000/QALY. We can be 95% confident that the intervention would be considered 'good value' at $90 000/abstinent year at 25 weeks and $500/abstinent year at 78 weeks. Conclusions While extended-release naltrexone appears to be effective in increasing both quality-adjusted life-years (QALYs) and abstinence, it does not appear to be cost-effective using generally accepted value thresholds for QALYs, due to the high price of the injection. [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 Barriers linked to drug control systems are considered to contribute to inequitable access to controlled medicines, leaving millions of people in pain and suffering. Most studies focus on access to opioids for the treatment of severe (cancer) pain. This study aims to identify specific access barriers for patients with opioid dependence in legislation and regulations of 11 central and eastern European countries. Methods This study builds on a previous analysis of legislation and regulations as part of the EU 7th Framework Access To Opioid Medication in Europe (ATOME) project. An in-depth analysis was undertaken to determine specific barriers for patients with opioid dependence in need of opioid analgesics or opioid agonist therapy (OAT). For each country, the number and nature of specific potential barriers for these patients were assessed according to eight categories: prescribing; dispensing; manufacturing; usage; trade and distribution; affordability; penalties; and other. An additional keyword search was conducted to minimize the omission of barriers. Barriers in an additional category, language, were recorded qualitatively. Countries included Bulgaria, Cyprus, Estonia, Greece, Hungary, Latvia, Lithuania, Serbia, Slovakia, Slovenia and Turkey. Results Ten of the 11 countries (all except Estonia) showed specific potential barriers in their legislation and regulations. The total number of barriers varied from two (Slovenia) to 46 (Lithuania); the number of categories varied from one (Slovenia) to five (Lithuania). Most specific potential barriers were shown in the categories 'prescribing', 'usage' and 'other'. The total number in a single category varied from one to 18 (Lithuania, prescribing). Individual differences between countries in the same specific potential barrier were shown; for example, variation in minimum age criteria for admission to OAT ranging from 15 (Lithuania, in special cases) to 20 years (Greece). All countries had stigmatizing language in their legislation. Conclusions Patients with opioid dependence are likely to experience specific barriers to accessing opioids in addition to those experienced by other non-dependent patients. [ABSTRACT FROM AUTHOR]

Aims Screening and brief intervention for harmful substance use in medical settings is being promoted heavily in the United States. To justify service provision fiscally, the field needs accurate estimates of the number and type of staff required to provide services, and thus the time taken to perform activities used to deliver services. This study analyzed the time spent in activities for the component services of the substance misuse Screening, Brief Intervention and Referral to Treatment (SBIRT) program implemented in emergency departments, in-patient units and ambulatory clinics. Design Observers timed activities according to 18 distinct codes among SBIRT practitioners. Setting Twenty-six US sites within four grantees. Participants Five hundred and one practitioner-patient interactions; 63 SBIRT practitioners. Measurements Timing of practitioner activities. Interventions Delivery of component services of SBIRT. Findings The mean (standard error) time to deliver services was 1:19 (0:06) for a pre-screen ( n = 210), 4:28 (0:24) for a screen ( n = 97) and 6:51 (0:38) for a brief intervention ( n = 66). Estimates of service duration varied by setting. Overall, practitioners spent 40% of their time supporting SBIRT delivery to patients and 13% of their time delivering services. Conclusions In the United States, support activities (e.g. reviewing the patient's chart, locating the patient, writing case-notes) for substance abuse Screening, Brief Intervention and Referral to Treatment require more staff time than delivery of services. Support time for screens and brief interventions in the emergency department/trauma setting was high compared with the out-patient setting. [ABSTRACT FROM AUTHOR]

Aims To estimate changes in the substance use behaviors of patients who received services as part of the US Substance Abuse and Mental Health Services Administration's (SAMHSA) Screening, Brief Intervention and Referral to Treatment (SBIRT) grant program. Methods We use a pre-post design and performance monitoring data collected by SBIRT organizations. For a sample of 17 575 patients, we compare pre-SBIRT substance use with substance use 6 months after receipt of SBIRT services. SBIRT's correlation with changes in substance use was estimated using generalized linear mixed models to account for the clustering of patients within health-care facility and US state. Results From pre- to post-SBIRT we found large and statistically significant decreases for almost every measure of substance use. Model-adjusted means indicate that the prevalence of alcohol use was lower 6 months later by 35.6%, heavy drinking by 43.4% and illicit drug use by 75.8%. Greater intervention intensity was associated with larger decreases in substance use. The study design does not support causal conclusions and estimated decreases in reported substance use are due, at least in part, to a well-known set of confounders and natural substance use patterns that may be unrelated to any particular SBIRT intervention. Conclusions Compared with previously published findings on the Screening, Brief Intervention and Referral to Treatment grant program, our estimates of substance use reduction were smaller, but still consistently large in absolute magnitude and within ranges of estimates from past trials of Screening, Brief Intervention and Referral to Treatment. [ABSTRACT FROM AUTHOR]

Aims To conduct a cost-effectiveness analysis (CEA) comparing the delivery of brief intervention (BI) with brief treatment (BT) within Screening, Brief Intervention and Referral to Treatment (SBIRT) programs. Design Quasi-experimental differences in observed baseline characteristics between BI and BT patients were adjusted using propensity score techniques. Incremental comparison of costs and health outcomes associated with BI and BT. Setting Health-care settings in four US states participating in Substance Abuse and Mental Health Services Administration SBIRT grant programs. Participants Ninety patients who received BT and 878 who received BI. Measurements Per-patient cost of SBIRT, patient demographics and six measures of substance use: proportion using alcohol, proportion using alcohol to intoxication, days of alcohol use, days of alcohol use to intoxication, proportion using drugs and days using drugs. Findings BI and BT were associated with better outcomes. The cost of SBIRT was significantly higher for BT patients ($75.54 versus 16.32, 95% confidence interval, P < 0.01). BT would be cost-effective if the decision-maker had a willingness to pay of $8.90 for a 1 percentage point reduction in the probability of using any alcohol. For the other five outcomes, BT was less effective and more costly, and BI would be a better use of resources. Conclusions It might be cost-effective to offer brief treatment if the goal is to abstain from alcohol. However, the higher effectiveness of brief treatment for this outcome is associated with considerable uncertainty and, because both brief intervention and brief treatment improve all outcomes, brief treatment does not appear to be a good use of resources. [ABSTRACT FROM AUTHOR]

Background and aims This is the first study to examine the effect of alcohol marketing exposure on adolescents' drinking in a cross-national context. The aim was to examine reciprocal processes between exposure to a wide range of alcohol marketing types and adolescent drinking, controlled for non-alcohol branded media exposure. Design Prospective observational study (11-12- and 14-17-month intervals), using a three-wave autoregressive cross-lagged model. Setting School-based sample in 181 state-funded schools in Germany, Italy, Netherlands, Poland. Participants A total of 9075 eligible respondents participated in the survey (mean age 14 years, 49.5% male. Measurements Adolescents reported their frequency of past-month drinking and binge drinking. Alcohol marketing exposure was measured by a latent variable with 13 items measuring exposure to online alcohol marketing, televised alcohol advertising, alcohol sport sponsorship, music event/festival sponsorship, ownership alcohol-branded promotional items, reception of free samples and exposure to price offers. Confounders were age, gender, education, country, internet use, exposure to non-alcohol sponsored football championships and television programmes without alcohol commercials. Findings The analyses showed one-directional long-term effects of alcohol marketing exposure on drinking (exposure T1 on drinking T2: β = 0.420 (0.058), P < 0.001, 95% confidence interval (CI) = 0.324-0.515; exposure T2 on drinking T3: β = 0.200 (0.044), P < 0.001, 95% CI = 0.127-0.272; drinking T1 and drinking T2 on exposure: P > 0.05). Similar results were found in the binge drinking model (exposure T1 on binge T2: β = 0.409 (0.054), P < 0.001, 95% CI = 0.320-0.499; exposure T2 on binge T3: β = 0.168 (0.050), P = 0.001, 95% CI = 0.086-0.250; binge T1 and binge T2 on exposure: P > 0.05). Conclusions There appears to be a one-way effect of alcohol marketing exposure on adolescents' alcohol use over time, which cannot be explained by either previous drinking or exposure to non-alcohol-branded marketing. [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]

Background and Aims Supervised injection facilities (legally sanctioned spaces for supervised consumption of illicitly obtained drugs) are controversial public health interventions. We determined the optimal number of facilities in two Canadian cities using health economic methods. Design Dynamic compartmental model of HIV and hepatitis C transmission through sexual contact and sharing of drug use equipment. Setting Toronto and Ottawa, Canada. Participants Simulated population of each city. Interventions Zero to five supervised injection facilities. Measurements Direct health-care costs and quality-adjusted life-years (QALYs) over 20 years, discounted at 5% per year; incremental cost-effectiveness ratios. Findings In Toronto, one facility cost $4.1 million and resulted in a gain of 385 QALYs over 20 years, for an incremental cost-effectiveness ratio (ICER) of $10 763 per QALY [95% credible interval (95CrI): cost-saving to $278 311]. Establishing one facility in Ottawa had an ICER of $6127 per QALY (95CrI: cost-saving to $179 272). At a $50 000 per QALY threshold, three facilities would be cost-effective in Toronto and two in Ottawa. The probability that establishing three, four, or five facilities in Toronto was cost-effective was 17, 21, and 41%, respectively. Establishing one, two, or three facilities in Ottawa was cost-effective with 13, 35, and 41% probability, respectively. Establishing no facility was unlikely to be the most cost-effective option (14% in Toronto and 10% in Ottawa). In both cities, results were robust if the reduction in needle-sharing among clients of the facilities was at least 50% and fixed operating costs were less than $2.0 million. Conclusions Using a $50 000 per quality-adjusted life-years threshold for cost-effectiveness, it is likely to be cost-effective to establish at least three legally sanctioned spaces for supervised injection of illicitly obtained drugs in Toronto, Canada and two in Ottawa, Canada. [ABSTRACT FROM AUTHOR]

Background and Aims Flaws in previous studies mean that findings of J-shaped risk curves for gambling should be disregarded. The current study aims to estimate the shape of risk curves for gambling losses and risk of gambling-related harm (a) for total gambling losses and (b) disaggregated by gambling activity. Design Four cross-sectional surveys. Setting Nationally representative surveys of adults in Australia (1999), Canada (2000), Finland (2011) and Norway (2002). Participants A total of 10 632 Australian adults, 3120 Canadian adults, 4484 people aged 15-74 years in Finland and 5235 people aged 15-74 years in Norway. Measurements Problem gambling risk was measured using the modified South Oaks Gambling Screen, the NORC DSM Screen for Gambling Problems and the Problem Gambling Severity Index. Findings Risk curves for total gambling losses were estimated to be r-shaped in Australia {β losses = 4.7 [95% confidence interval (CI) = 3.8, 6.5], β losses2 = -7.6 (95% CI = -17.5, -4.5)}, Canada [β losses = 2.0 (95% CI = 1.3, 3.9), β losses2 = -3.9 (95% CI = -15.4, -2.2)] and Finland [β losses = 3.6 (95% CI = 2.5, 7.5), β losses2 = -4.4 (95% CI = -34.9, -2.4)] and linear in Norway [β losses = 1.6 (95% CI = 0.6, 3.1), β losses2 = -2.6 (95% CI = -12.6, 1.4)]. Risk curves for different gambling activities showed either linear, r-shaped or non-significant relationships. Conclusions Player loss-risk curves for total gambling losses and for different gambling activities are likely to be linear or r-shaped. For total losses and electronic gaming machines, there is no evidence of a threshold below which increasing losses does not increase the risk of harm. [ABSTRACT FROM AUTHOR]

Background and Aims Current pharmacotherapies for tobacco dependence are generally well tolerated, but have relatively high rates of relapse. They target primarily the brains' mesocorticolimbic 'reward' pathway. However, recent evidence suggests that the insular cortex, a central cerebral hemispheric region historically overlooked in addiction models, may also play an important role in cognitive and emotional processes that facilitate drug use. We examined whether insular versus non-insular damage from ischemic stroke attenuated acute withdrawal from cigarette smoking and reduced the likelihood of nicotine replacement therapy (NRT) use during hospitalization. Design Data were derived from a longitudinal study with 3 months' follow-up, beginning June 2013 and ending May 2014. Setting Three acute care hospitals in Rochester, NY, USA. Participants One-hundred and fifty-six current smokers hospitalized for acute ischemic stroke (38 with insular infarctions and 118 with non-insular infarctions, assessed by three neuroradiologists). Measurements The Wisconsin Smoking Withdrawal Scale (WSWS) and Minnesota Nicotine Withdrawal Scale (MNWS) were administered during hospitalization (a period of forced abstinence) to assess the frequency and severity of withdrawal symptoms. NRT use was also assessed during hospitalization. Findings On average, smokers with insular damage had a lower WSWS score during admission [mean = 5.89, standard deviation (SD) = 4.72] compared with those with non-insular damage (mean = 9.20, SD = 4.71; P < 0.001) [covariate-adjusted difference in means of -3.12, 95% confidence interval (CI) = -4.97, -1.27]. A similar difference was also noted when the MNWS was used ( P = 0.02). Furthermore, participants with insular lesions appeared to be less likely to use NRT during admission compared with those with non-insular lesions [odds ratio (OR) = 0.72, 95% CI = 0.32, 1.64]. Conclusions Current smokers with damage to their insular cortex brain region appear to experience fewer and less severe tobacco withdrawal symptoms, and appear to be less likely to require nicotine replacement therapy during hospitalization, compared with smokers with non-insular damage. These findings support the potential role of the insular cortex in regulating withdrawal during abstinence, a motivator responsible for the maintenance of addictive behaviors. [ABSTRACT FROM AUTHOR]

Aims Most people who quit smoking for a short term will return to smoking again in 12 months. We tested whether self-help booklets can reduce relapse in short-term quitters after receiving behavioural and pharmacological cessation treatment. Design A parallel-arm, pragmatic individually randomized controlled trial. Setting Smoking cessation clinics in England. Participants People who stopped smoking for 4 weeks after receiving cessation treatment in stop smoking clinics. Intervention Participants in the experimental group (n = 703) were mailed eight booklets, each of which taught readers how to resist urges to smoke. Participants in the control group (n = 704) received a leaflet currently used in practice. Measurements The primary outcome was prolonged, carbon monoxide-verified abstinence from months 4 to 12. The secondary outcomes included 7-day self#x02010;reported abstinence at 3 and 12 months. Mixed-effects logistic regression was used to estimate treatment effects and to investigate possible effect modifying variables. Findings There were no statistically significant differences between the groups in prolonged abstinence from months 4 to 12 (36.9% versus 38.6%; odds ratio 0.93, 95% confidence interval 0.75-1.16; P = 0.524). In addition, there were no significant differences between the groups in any secondary outcomes. However, people who reported knowing risky situations for relapse and using strategies to handle urges to smoke were less likely to relapse. Conclusions In people who stop smoking successfully with behavioural support, a comprehensive self-help educational programme to teach people skills to identify and respond to high-risk situations for return to smoking did not reduce relapse. [ABSTRACT FROM AUTHOR]

Aims To examine whether young adults' alcohol consumption during the course of an evening was affected by the number of friends present, and the interaction between participants' gender and number of friends present. Design Participants used the internet-based cellphone-optimized assessment technique (ICAT) to complete a series of cellphone questionnaires every Thursday, Friday and Saturday evening over five weekends. A multi-level growth curve model (hourly assessments, clustered within evenings, clustered within individuals) with time-invariant and time-varying covariates was estimated. Setting French-speaking Switzerland. Participants A total of 183 young adults (53.0% female, mean age = 23.1) who completed 7205 questionnaires on 1441 evenings. Measurements Alcohol consumption and number of friends present assessed at 8 p.m., 9 p.m., 10 p.m., 11 p.m. and midnight. Findings Drinking pace accelerated notably over the course of the evening on Saturdays ( b = 0.047; P < 0.01). Men consumed more alcohol than women, particularly at the beginning of the evening ( b = 0.152; P < 0.05). However, this effect was no longer significant when the impact of friends was accounted for ( b = 0.096; P = 0.139). The higher the number of friends present, the higher the number of drinks consumed at a given time during the course of the evening ( b = 0.070; P < 0.001). Cross-level interaction effects indicated that this relationship was stronger for men than women ( b = 0.027; P < 0.05). Conclusions Among young adults in Switzerland, the number of friends present is associated positively with hourly drinking frequency during the course of weekend evenings. The impact of the drinking group size on alcohol use is stronger for men than women. [ABSTRACT FROM AUTHOR]

Aims To investigate the association between frequency of visiting shops and noticing of tobacco point-of-sale (PoS) displays and the development of susceptibility to smoking, or smoking uptake, in secondary school students. Design Two surveys of a school based cohort study carried out in 2011 and 2012. Settings Nottinghamshire, UK. Participants A total of 2270 children aged 11-16 years from eight schools in Nottinghamshire. Measurements We investigated changes in susceptibility to smoking and smoking status in relation to frequency of visiting shops and noticing PoS displays and number of tobacco brands recognized, controlling for a range of potential confounders. Susceptibility to smoking was defined using a set of three questions covering intentions to try smoking, to smoke within the next year and likelihood of smoking if a best friend offered a cigarette. For the analysis we used multinomial logistic regression. Findings Among non-susceptible never smokers, noticing PoS displays more frequently was associated independently with an increased risk of becoming susceptible to smoking [adjusted relative risk ratio (RRR) = 1.74; 99% confidence interval (CI) = 1.13-2.69], but was not associated with smoking uptake. Recognizing a higher number of brands among non-susceptible never smokers doubled the risk of becoming susceptible to smoking and of becoming a smoker, but this did not have a significant effect on transition to smoking among susceptible never smokers. Frequency of noticing tobacco PoS displays was not associated significantly with smoking uptake among those who were susceptible never smokers at baseline. Conclusions Noticing tobacco point-of-sale displays more often and recognizing a higher number of tobacco brands is associated with an increased risk of becoming susceptible to smoking among adolescents in the United Kingdom, and recognizing a higher number of brands is associated positively with an increased risk of smoking uptake. [ABSTRACT FROM AUTHOR]

Aims The Randomized Injectable Opioid Treatment Trial ( RIOTT) compared supervised injectable heroin ( SIH) and supervised injectable methadone ( SIM) with optimized oral methadone ( OOM) ( ISRCTN0133807). Heroin addicts (previously unresponsive to treatment) made significant reductions in street heroin use at 6 months when treated with SIH. We now examine secondary outcomes. Design Multi-site randomized controlled trial ( RCT) comparing SIH versus OOM and SIM versus OOM. Setting Three supervised injectable opiate clinics in England. Participants Chronic refractory heroin addicts continuing to inject street heroin virtually daily despite oral substitution treatment ( n = 127), randomized to either SIH( n = 43), SIM( n = 42) or OOM( n = 42). All received high levels of medical and psychosocial support. Measurements Secondary outcomes: wider drug use, crime, health and social functioning at 6 months. Findings At 6 months, no significant differences were found between treatment groups in wider drug use (crack/cocaine, benzodiazepines, alcohol), physical and mental health ( SF-36) or social functioning. Within each treatment group, significant reductions were observed in crime [ SIH = odds ratio ( OR) 0.05; P < 0.001; SIM = OR 0.11; P = 0.002; OOM = OR 0.11; P = 0.003] and money spent per week on illicit drugs ( SIH = mean change £-289.43; P < 0.001; SIM = mean change £-183.41; P < 0.001; OOM = mean change £-162.80; P < 0.001), with SIH significantly more likely to have reduced money spent on illicit drugs versus OOM (mean difference £-92.04; P < 0.001). Significant improvements were seen in physical health for SIH and SIM ( SIH = mean change 3.97; P = 0.008; SIM = mean change 4.73; P = 0.002) and mental health for OOM (mean change 6.04; P = 0.013). Conclusions Supervised injectable heroin treatment and supervised injectable methadone treatment showed no clearly identified benefit over optimized oral methadone in terms of wider drug use, crime, physical and mental health within a 6-month period, despite reducing street heroin use to a greater extent. However, all interventions were associated with improvements in these outcomes. [ABSTRACT FROM AUTHOR]

Aim To investigate the characteristics of the different club drugs and associated high-risk sexual behaviours in China. Design Multicentre cross-sectional study. Setting Drug Detoxification and Rehabilitation Centres in six provinces, China. Participants A total of 1434 eligible club drug users were included. Measurements Participants were investigated by trained interviewers using a self-designed structured questionnaire to collect information on club drug use and associated behaviours. Findings Methamphetamine was the most commonly abused drug in participants (73.92%), who used it in their or their friends' homes by non-injection for the purpose of feeling euphoria. Among participants with sexual behaviours after club drug use, 75.21% reported having engaged in sex with multiple partners after club drug use during the past year and 79.84% had unprotected sex after using club drug during the past year. A two-level logistic model showed that male gender [adjusted odds ratio ( AOR) = 7.14; 95% confidence interval ( CI) = 4.17-12.5], unmarried ( AOR = 1.71, 95% CI = 1.04-2.79), long duration of club drug use during their life-time ( AOR = 1.76, 95% CI = 1.28-2.42) and severe acute intoxication after using club drugs during the past year ( AOR = 2.11, 95% CI = 1.07-4.15) were independent risk factors of multiple sex partners during the past year. Another two-level model showed that the club drug users who were female ( AOR = 1.79, 95% CI = 1.03-3.11) and had polydrug use during their lifetime ( AOR = 1.55, 95% CI = 1.01-2.34) had more risk for unprotected sex during the past year than without these characteristics. Conclusion High-risk sexual behaviours are common among club drug users in China. The prevention and intervention of club drug use could decrease the risk of sexual behaviours which further prevent HIV transmission and other sexually transmitted infections in China. [ABSTRACT FROM AUTHOR]

Aims To compare three missing data strategies: (i) the latent growth model that assumes the data are missing at random ( MAR) model; (ii) the Diggle- Kenward missing not at random ( MNAR) model, where dropout is a function of previous/concurrent urinalysis ( UA) submissions; and (iii) the Wu- Carroll MNAR model where dropout is a function of the growth factors. Design Secondary data analysis of a National Drug Abuse Treatment Clinical Trials Network trial that examined a 7-day versus 28-day taper (i.e. stepwise decrease in buprenorphine/naloxone) on the likelihood of submitting an opioid-positive UA during treatment. Setting 11 out-patient treatment settings in 10 US cities. Participants A total of 516 opioid-dependent participants. Measurements Opioid UAs provided across the 4-week treatment period. Findings The MAR model showed a significant effect ( B = −0.45, P < 0.05) of trial arm on the opioid-positive UA slope (i.e. 28-day taper participants were less likely to submit a positive UA over time) with a small effect size ( d = 0.20). The MNAR Diggle- Kenward model demonstrated a significant ( B = −0.64, P < 0.01) effect of trial arm on the slope with a large effect size ( d = 0.82). The MNAR Wu- Carroll model showed a significant ( B = −0.41, P < 0.05) effect of trial arm on the UA slope that was relatively small ( d = 0.31). Conclusions This performance comparison of three missing data strategies (latent growth model, Diggle- Kenward selection model, Wu- Carrol selection model) on sample data indicates a need for increased use of sensitivity analyses in clinical trial research. Given the potential sensitivity of the trial arm effect to missing data assumptions, it is critical for researchers to consider whether the assumptions associated with each model are defensible. [ABSTRACT FROM AUTHOR]

Aims To determine comorbidity patterns in treatment-seeking substance use disorder ( SUD) patients with and without adult attention deficit hyperactivity disorder ( ADHD), with an emphasis on subgroups defined by ADHD subtype, taking into account differences related to gender and primary substance of abuse. Design Data were obtained from the cross-sectional International ADHD in Substance use disorder Prevalence ( IASP) study. Setting Forty-seven centres of SUD treatment in 10 countries. Participants A total of 1205 treatment-seeking SUD patients. Measurements Structured diagnostic assessments were used for all disorders: presence of ADHD was assessed with the Conners' Adult ADHD Diagnostic Interview for DSM-IV ( CAADID), the presence of antisocial personality disorder ( ASPD), major depression ( MD) and (hypo)manic episode ( HME) was assessed with the Mini International Neuropsychiatric Interview- Plus ( MINI Plus), and the presence of borderline personality disorder ( BPD) was assessed with the Structured Clinical Interview for DSM-IV Axis II ( SCID II). Findings The prevalence of DSM-IV adult ADHD in this SUD sample was 13.9%. ASPD [odds ratio ( OR) = 2.8, 95% confidence interval ( CI) = 1.8-4.2], BPD ( OR = 7.0, 95% CI = 3.1-15.6 for alcohol; OR = 3.4, 95% CI = 1.8-6.4 for drugs), MD in patients with alcohol as primary substance of abuse ( OR = 4.1, 95% CI = 2.1-7.8) and HME ( OR = 4.3, 95% CI = 2.1-8.7) were all more prevalent in ADHD+ compared with ADHD− patients ( P < 0.001). These results also indicate increased levels of BPD and MD for alcohol compared with drugs as primary substance of abuse. Comorbidity patterns differed between ADHD subtypes with increased MD in the inattentive and combined subtype ( P < 0.01), increased HME and ASPD in the hyperactive/impulsive ( P < 0.01) and combined subtypes ( P < 0.001) and increased BPD in all subtypes ( P < 0.001) compared with SUD patients without ADHD. Seventy-five per cent of ADHD patients had at least one additional comorbid disorder compared with 37% of SUD patients without ADHD. Conclusions Treatment-seeking substance use disorder patients with attention deficit hyperactivity disorder are at a very high risk for additional externalizing disorders. [ABSTRACT FROM AUTHOR]

Aims To examine non-medical use of prescription opioids ( NMUPO) patterns during the transition from adolescence to adulthood, and assess individual characteristics and other substance use behaviors associated with longitudinal patterns of NMUPO. Design Nationally representative samples of high school seniors in the United States (wave 1: modal age 18 years) were followed longitudinally across three biennial follow-up waves (waves 2, 3 and 4: modal ages 19/20, 21/22 and 23/24 years). Setting Data were collected via self-administered questionnaires to high school seniors and young adults. Participants The longitudinal sample consisted of 27 268 individuals in 30 cohorts (high school senior years 1976-2005) who participated in all four waves. Measurements Self-reports of NMUPO and other substance use behaviors. Findings Approximately 11.6% [95% confidence interval ( CI) = 11.2%, 12.0%] of the sample reported past-year NMUPO in at least one of the four waves. Among those who reported past-year NMUPO in at least one wave, 69.0% (67.6%, 70.4%), 20.5% (19.3%, 21.7%), 7.8% (7.1%, 8.6%) and 2.7% (2.3%, 3.1%) reported NMUPO at one, two, three and four waves, respectively. Several wave 1 variables were associated with greater odds of multiple waves of NMUPO and individuals who reported more waves of NMUPO had greater odds of other substance use behaviors. Conclusions Although most non-medical use of prescription opioids among 18-year-olds in the United States appears to be non-continuing, approximately one-third of the sample reporting non-medical use of prescription opioids appear to continue use beyond age 18 and have elevated odds of other substance use behaviors at ages 23/24. [ABSTRACT FROM AUTHOR]

Aims To investigate the relationship between legalization of Sunday alcohol sales and alcohol consumption in the United States. Design State-level per capita consumption of beer, wine and spirits was analyzed using difference-in-differences econometric methods. Setting United States. Participants Five treatment states that repealed their laws restricting Sunday alcohol sales during 1990-2007 and 12 control states that retained their Sunday alcohol laws during the same period. Measurements Outcome measures are state-level per capita consumption of overall alcohol, beer, wine and spirits. Findings Among the states that legalized Sunday sales of alcoholic beverages, Delaware, Pennsylvania and New Mexico experienced significant increases in overall alcohol consumption ( P < 0.05). However, the effect of the legalization of Sunday alcohol sales in Massachusetts and Rhode Island on per capita alcohol consumption was insignificant ( P = 0.964 and P = 0.367). Conclusions Three out of five states in the United States that repealed their laws restricting Sunday sale of alcoholic beverages during 1990-2007 experienced significant increases in per capita alcohol consumption. This finding implies that increased alcohol availability leads to an increase in alcohol consumption. [ABSTRACT FROM AUTHOR]

Aims Investigators of the COMBINE ( Combining Medications and Behavioral Interventions for Alcoholism) study examined whether combining medications with a behavioral intervention would improve outcomes over monotherapies. Unexpectedly, the combination did not offer any advantage over either treatment alone. This study aimed to explain the lack of incremental benefit offered by the combination over either monotherapy by assessing the role of cravings as a treatment mediator and moderator. Design Secondary mediation and moderation analyses of COMBINE study data. Setting Eleven United States academic sites. Participants A total of 863 patients randomized to one of four treatment groups: naltrexone (100 mg/day; n = 209), the combined behavioral intervention ( CBI, n = 236), naltrexone and CBI combined ( n = 213) and placebo naltrexone ( n = 205). Measurements Percentage of days abstinent ( PDA) measured between 13 and 16 weeks post-baseline. Cravings, the potential mediator/moderator, were measured at baseline, weeks 4 and 12 using the Obsessive- Compulsive Drinking Scale. Findings Compared with placebo, naltrexone, CBI and the combination all increased PDA by an additional 6-10 percentage points for those with high cravings ( P < 0.05 for all three treatment groups). None had significant effects on PDA for those with low cravings. The effects of all three treatments were mediated at least partially by cravings; craving reduction explained 48-53% of treatment effects ( P < 0.05 for all three treatment groups). Furthermore, naltrexone appeared to reduce cravings at 4 weeks, while CBI did not reduce cravings until 12 weeks. Conclusions The Combining Medications and Behavioral Interventions for Alcoholism ( COMBINE) naltrexone + CBI combination may not be more beneficial than either monotherapy because craving reduction is a common mechanism of both. [ABSTRACT FROM AUTHOR]

Aims Like many indigenous peoples, New Zealand Māori bear a heavy burden of alcohol-related harm relative to their non-indigenous compatriots, and disparities are greatest among young adults. We tested the effectiveness of web-based alcohol screening and brief intervention (e- SBI) for reducing hazardous drinking among Māori university students. Design Parallel, double-blind, multi-site, randomized controlled trial. Setting Seven of New Zealand's eight universities. Participants In April 2010, we sent e-mail invitations to all 6697 17-24-year-old Māori students to complete a brief web questionnaire including the Alcohol Use Disorders Identification Test ( AUDIT)- C, a screening tool for hazardous and harmful drinking. Those screening positive were computer randomized to: <10 minutes of web-based alcohol assessment and personalized feedback (intervention) or screening alone (control). Measurements We conducted a fully automated 5-month follow-up assessment with observers and participants blinded to study hypotheses, design and intervention delivery. Pre-determined primary outcomes were: (i) frequency of drinking, (ii) amount consumed per typical drinking occasion, (iii) overall volume of alcohol consumed and (iv) academic problems. Findings Of the participants, 1789 were hazardous or harmful drinkers ( AUDIT- C ≥ 4) and were randomized: 850 to control, 939 to intervention. Follow-up assessments were completed by 682 controls (80%) and 733 intervention group members (78%). Relative to controls, participants receiving intervention drank less often [ RR = 0.89; 95% confidence interval (CI): 0.82-0.97], less per drinking occasion ( RR = 0.92; 95% CI: 0.84-1.00), less overall ( RR = 0.78; 95% CI: 0.69-0.89) and had fewer academic problems ( RR = 0.81; 95% CI: 0.69-0.95). Conclusions Web-based screening and brief intervention reduced hazardous and harmful drinking among non-help-seeking Māori students in a large-scale pragmatic trial. The study has wider implications for behavioural intervention in the important but neglected area of indigenous health. [ABSTRACT FROM AUTHOR]

Aim To evaluate smokeless tobacco cessation in communities of South Asian origin. Design Multi-centre prospective cohort study. Setting Three tobacco cessation services offering specialist smokeless tobacco cessation outreach clinic support to South Asians ( Bangladeshi, Indian and Pakistani) resident in England. Participants A total of 239 South Asian participants seeking to stop smokeless tobacco use between November 2010 and December 2011. Measurements Socio-demographics, tobacco use and dependence, self-reported abstinence at 4 weeks and satisfaction measures. Findings Participants' mean age was 45 [standard deviation ( SD) = 13] years, were predominantly female (76%), of Bangladeshi origin (74%), either home carers (53%) or not working (29%). Sixty-three per cent were recruited from community locations, 21% through a clinical contact and 16% through friends and family. Mean daily number of smokeless tobacco intakes was 10 ( SD = 7) and the mean dependence score was 4.5 ( SD = 1.9). Sixty-three per cent of participants achieved continuous abstinence 4 weeks after quitting. Using nicotine replacement therapy ( NRT) versus not using it [ OR = 3.47, 95% confidence interval ( CI): 1.25, 9.62] and below median (≤8) daily smokeless tobacco intakes ( OR = 1.91, 95% CI: 1.07, 3.40) predicted successful abstinence. Conclusion South Asian smokeless tobacco users resident in England accessing services to help them stop appear to have short-term success rates comparable with smokers attending stop-smoking services, with higher success rates being reported by those using nicotine replacement therapy. [ABSTRACT FROM AUTHOR]

Aims To examine the relationship of anxiety and depression symptoms with treatment outcomes (treatment discontinuation, rates of ongoing use of illicit drugs and likelihood of preterm delivery) in opioid-dependent pregnant women and describe their use of psychotropic medications. Design and setting Secondary data analysis from a randomized clinical trial of treatment for opioid dependence during pregnancy. Participants A total of 175 opioid-dependent pregnant women, of whom 131 completed treatment. Measurements Symptoms of anxiety and depression were captured with the 15-item Mini International Neuropsychiatric Interview ( MINI) screen. Use of illicit drugs was measured by urine drug screening. Preterm delivery was defined as delivery prior to 37 weeks' gestation. Self-reported use of concomitant psychotropic medication at any point during the study was recorded. Findings Women reporting only anxiety symptoms at study entry were more likely to discontinue treatment [adjusted odds ratio ( OR) = 4.56, 95% confidence interval ( CI): 1.91-13.26, P = 0.012], while those reporting only depression symptoms were less likely to discontinue treatment (adjusted OR = 0.14, 95% CI: 0.20-0.88, P = 0.036) compared to women who reported neither depression nor anxiety symptoms. No statistically significant between-group differences were observed for ongoing illicit drug use or preterm delivery. A majority (61.4%) of women reported use of concomitant psychotropic medication at some point during study participation. Conclusions Opioid agonist-treated pregnant patients with co-occurring symptoms of anxiety require additional clinical resources to prevent premature discontinuation. [ABSTRACT FROM AUTHOR]

Aims To compare the profile of signs of neonatal abstinence syndrome ( NAS) in methadone- versus buprenorphine-exposed infants. Design, setting and participants Secondary analysis of NAS data from a multi-site, double-blind, double-dummy, flexible-dosing, randomized clinical trial. Data from a total of 129 neonates born to opioid-dependent women who had been assigned to receive methadone or buprenorphine treatment during pregnancy were examined. Measurements For 10 days after delivery, neonates (methadone = 72, buprenorphine = 57) were assessed regularly using a 19-item modified Finnegan scale. Data from neonates who required pharmacological treatment (methadone = 41, buprenorphine = 27) were included up to the time treatment was initiated. The incidence and mean severity of the total NAS score and each individual sign of NAS were calculated and compared between medication conditions, as was the median time until morphine treatment initiation among treated infants in each condition. Findings Two NAS signs (undisturbed tremors and hyperactive Moro reflex) were observed significantly more frequently in methadone-exposed neonates and three (nasal stuffiness, sneezing, loose stools) were observed more frequently in buprenorphine-exposed neonates. Mean severity scores on the total NAS score and five individual signs (disturbed and undisturbed tremors, hyperactive Moro reflex, excessive irritability, failure to thrive) were significantly higher among methadone-exposed neonates, while sneezing was higher among buprenorphine-exposed neonates. Among treated neonates, methadone-exposed infants required treatment significantly earlier than buprenorphine-exposed infants (36 versus 59 hours postnatal, respectively). Conclusions The profile of neonatal abstinence syndrome differs in methadone- versus buprenorphine-exposed neonates, with significant differences in incidence, severity and treatment initiation time. Overall, methadone-exposed neonates have a more severe neonatal abstinence syndrome. [ABSTRACT FROM AUTHOR]

Aim To determine pre- and post-dosing effects of prenatal methadone compared to buprenorphine on fetal wellbeing. Design A secondary analysis of data derived from the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study, a double-blind, double-dummy, randomized clinical trial. Setting Six United States sites and one European site that provided comprehensive opioid-dependence treatment to pregnant women. Participants Eighty-one of the 131 opioid-dependent pregnant women completing the MOTHER clinical trial, assessed between 31 and 33 weeks of gestation. Measurements Two fetal assessments were conducted, once before and once after study medication dosing. Measures included mean fetal heart rate ( FHR), number of FHR accelerations, FHR reactivity in the fetal non-stress test ( NST) and biophysical profile ( BPP) score. Findings Significant group differences were found for number of FHR accelerations, non-reactive NST and BPP scores (all Ps < 0.05). There were no significant group differences before time of dosing. Significant decreases (all Ps < 0.05) occurred from pre- to post-dose assessment for mean FHR, FHR accelerations, reactive NST and fetal movement. The decrease in accelerations and reactive NST were significant only for fetuses in the methadone group, and this resulted in a significantly lower likelihood of a reactive NST compared to fetuses in the buprenorphine group. Conclusion Buprenorphine compared with methadone appears to result in less suppression of mean fetal heart rate, fetal heart rate reactivity and the biophysical profile score after medication dosing and these findings provide support for the relative safety of buprenorphine when fetal indices are considered as part of the complete risk-benefit ratio. [ABSTRACT FROM AUTHOR]

Aim To identify factors that predict the expression of neonatal abstinence syndrome ( NAS) in infants exposed to methadone or buprenorphine in utero. Design and Setting Multi-site randomized clinical trial in which infants were observed for a minimum of 10 days following birth, and assessed for NAS symptoms by trained raters. Participants A total of 131 infants born to opioid dependent mothers, 129 of whom were available for NAS assessment. Measurements Generalized linear modeling was performed using maternal and infant characteristics to predict: peak NAS score prior to treatment, whether an infant required NAS treatment, length of NAS treatment and total dose of morphine required for treatment of NAS symptoms. Findings Of the sample, 53% (68 infants) required treatment for NAS. Lower maternal weight at delivery, later estimated gestational age ( EGA), maternal use of selective serotonin re-uptake inhibitors ( SSRIs), vaginal delivery and higher infant birthweight predicted higher peak NAS scores. Higher infant birthweight and greater maternal nicotine use at delivery predicted receipt of NAS treatment for infants. Maternal use of SSRIs, higher nicotine use and fewer days of study medication received also predicted total dose of medication required to treat NAS symptoms. No variables predicted length of treatment for NAS. Conclusions Maternal weight at delivery, estimated gestational age, infant birthweight, delivery type, maternal nicotine use and days of maternal study medication received and the use of psychotropic medications in pregnancy may play a role in the expression of neonatal abstinence syndrome severity in infants exposed to either methadone or buprenorphine. [ABSTRACT FROM AUTHOR]

Aims The Maternal Opioid Treatment: Human Experimental Research ( MOTHER) project, an eight-site randomized, double-blind, double-dummy, flexible-dosing, parallel-group clinical trial is described. This study is the most current-and single most comprehensive-research effort to investigate the safety and efficacy of maternal and prenatal exposure to methadone and buprenorphine. Methods The MOTHER study design is outlined, and its basic features are presented. Conclusions At least seven important lessons have been learned from the MOTHER study: (i) an interdisciplinary focus improves the design and methods of a randomized clinical trial; (ii) multiple sites in a clinical trial present continuing challenges to the investigative team due to variations in recruitment, patient populations and hospital practices that, in turn, differentially impact recruitment rates, treatment compliance and attrition; (iii) study design and protocols must be flexible in order to meet the unforeseen demands of both research and clinical management; (iv) staff turnover needs to be addressed with a proactive focus on both hiring and training; (v) the implementation of a protocol for the treatment of a particular disorder may identify important ancillary clinical issues worthy of investigation; (vi) timely tracking of data in a multi-site trial is both demanding and unforgiving; and (vii) complex multi-site trials pose unanticipated challenges that complicate the choice of statistical methods, thereby placing added demands on investigators to effectively communicate their results. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smokers who lapse during a cessation attempt are at particularly high risk of relapse, so interventions to help smokers recover from lapses are urgently needed. Two recent studies have suggested continuing to use nicotine patches following a lapse may be a beneficial relapse prevention strategy. However, to date no study that uses approved doses of nicotine patches under real-world conditions has tested this hypothesis. Design and setting Clinical trial conducted across eight US study sites. Participants and measurements Using data from 509 subjects (240 active; 269 placebo) who lapsed during weeks 3-5 of treatment in a randomized, double-blind placebo-controlled trial of 21-mg nicotine patches, we examined whether active nicotine patch use improved the chances of recovering abstinence (7-day point-prevalence) at weeks 6 and 10. Findings Active patch use (versus placebo) increased the likelihood of recovery from a lapse both at 6 weeks [8.3% versus 0.8%; relative risk (RR) = 11.0, P < 0.001] and at 10 weeks (9.6% versus 2.6%; RR = 3.7, P < 0.001). Conclusions Continuing treatment to aid smoking cessation with active patches promotes recovery from lapses. Smokers should be encouraged to persist with patch treatment if they lapse to smoking. [ABSTRACT FROM AUTHOR]

ABSTRACT Aim While drinking in the event is an important factor in injury occurrence, the pattern of usual drinking may also be important in risk of injury. Explored here is the relationship of an alcohol-related injury with an individual usual drinking pattern. Design Alcohol-related injury is examined using hierarchical linear models, taking into account individual usual volume of consumption over the past 12 months, as well as aggregate-level detrimental drinking pattern (DDP) and alcohol policy measures. Setting Data analyzed are from emergency departments (EDs) in 19 countries, comprising three collaborative studies on alcohol and injury, all of which used a similar methodology. Participants The sample comprised 14 132 injured drinkers across 46 emergency room (ER) studies. Measurements Alcohol-related injury was measured, separately, by any self-reported drinking prior to injury, a blood alcohol concentration (BAC) ≥ 0.08 and self-reported causal attribution of injury to drinking. Findings While individual usual volume strongly predicted an alcohol-related injury for all three measures, usual drinking pattern also predicted an alcohol-related injury (controlling for volume), with episodic heavy and frequent heavy drinking both more predictive of alcohol-related injury than other drinking patterns. When individual usual volume and drinking pattern were controlled, DDP was no longer a significant predictor of alcohol-related injury. Alcohol policy measures were predictive of both BAC and causal attribution (the stronger the policy the lower the rates of alcohol-related injury). Conclusions Volume of alcohol typically consumed and occurrence of heavy drinking episodes are associated independently with incidence of alcohol-related injury. The stronger the anti-alcohol policies in a country, the lower the rates of alcohol-related injury. [ABSTRACT FROM AUTHOR]