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Background Alcoholics Anonymous (AA) is a world-wide recovery mutual-help organization that continues to arouse controversy. In large part, concerns persist because of AA's ostensibly quasi-religious/spiritual orientation and emphasis. In 1990 the United States' Institute of Medicine called for more studies on AA's effectiveness and its mechanisms of behavior change (MOBC) stimulating a flurry of federally funded research. This paper reviews the religious/spiritual origins of AA and its program and contrasts its theory with findings from this latest research. Method Literature review, summary and synthesis of studies examining AA's MOBC. Results While AA's original main text ('the Big Book', 1939) purports that recovery is achieved through quasi-religious/spiritual means ('spiritual awakening'), findings from studies on MOBC suggest this may be true only for a minority of participants with high addiction severity. AA's beneficial effects seem to be carried predominantly by social, cognitive and affective mechanisms. These mechanisms are more aligned with the experiences reported by AA's own larger and more diverse membership as detailed in its later social, cognitive and behaviorally oriented publications (e.g. Living Sober, 1975) written when AA membership numbered more than a million men and women. Conclusions Alcoholics Anonymous appears to be an effective clinical and public health ally that aids addiction recovery through its ability to mobilize therapeutic mechanisms similar to those mobilized in formal treatment, but is able to do this for free over the long term in the communities in which people live. [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]

Background and aims: Culturally relevant and feasible interventions are needed to address limited professional resources in sub‐Saharan Africa for behaviorally treating the dual epidemics of HIV and alcohol use disorder. This study tested the efficacy of a cognitive–behavioral therapy (CBT) intervention to reduce alcohol use among HIV‐infected outpatients in Eldoret, Kenya. Design Randomized clinical trial. Setting: A large HIV outpatient clinic in Eldoret, Kenya, affiliated with the Academic Model Providing Access to Healthcare collaboration. Participants: A total of 614 HIV‐infected outpatients [312 CBT; 302 healthy life‐styles (HL); 48.5% male; mean age: 38.9 years; mean education 7.7 years] who reported a minimum of hazardous or binge drinking. Intervention and comparator: A culturally adapted six‐session gender‐stratified group CBT intervention compared with HL education, each delivered by paraprofessionals over six weekly 90‐minute sessions with a 9‐month follow‐up. Measurements Primary outcome measures were percentage of drinking days (PDD) and mean drinks per drinking day (DDD) computed from retrospective daily number of drinks data obtained by use of the time‐line follow‐back from baseline to 9 months post‐intervention. Exploratory analyses examined unprotected sex and number of partners. Findings Median attendance was six sessions across condition. Retention at 9 months post‐intervention was high and similar by condition: CBT 86% and HL 83%. PDD and DDD marginal means were significantly lower in CBT than HL at all three study phases. Maintenance period, PDD – CBT = 3.64 (0.696), HL = 5.72 (0.71), mean difference 2.08, 95% confidence interval (CI) = 0.13 – 4.04; DDD – CBT = 0.66 (0.96), HL = 0.98 (0.098), mean difference = 0.31, 95% CI = 0.05 – 0.58. Risky sex decreased over time in both conditions, with a temporary effect for CBT at the 1‐month follow‐up. Conclusions: A cognitive–behavioral therapy intervention was more efficacious than healthy lifestyles education in reducing alcohol use among HIV‐infected Kenyan outpatient drinkers. [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: The United States Food and Drug Administration has proposed regulation to require that cigarettes contain very low nicotine content (VLNC). In contrast, reducing the number of cigarettes per day (CPD) is the most common current method to reduce nicotine. This trial aims to explore whether gradually transitioning to VLNC cigarettes plus nicotine patch or reducing CPD plus nicotine patch is more effective at decreasing nicotine dependence. Design A two‐arm, individually randomized open‐label trial. Setting Community setting, Vermont, USA. Participants: Sixty‐eight adult daily smokers (40% female) of ≥ 10 cigarettes/day who were not planning to quit in the next 30 days. Interventions: All participants smoked study cigarettes with a nicotine yield similar to most commercial cigarettes ad libitum for 1 week (baseline). Participants then gradually reduced to 70, 35, 15 and 3% of baseline nicotine over 4 weeks by either (a) transitioning to lower nicotine content cigarettes (n = 36) or (b) reducing the number of full nicotine cigarettes (n = 32). All participants received nicotine patches. Measurements The primary outcome was change in nicotine dependence assessed at baseline and weekly during the intervention with the Nicotine Dependence Syndrome Scale. Findings Dependence declined over time for both VLNC and CPD participants, but declined more for VLNC (mean decrease in Z‐score of 1.0) than CPD (mean decrease in Z‐score of 0.5) participants over time (interaction P = 0.018). Conclusions: Transitioning to very low nicotine content cigarettes reduced nicotine dependence over a 4‐week period to a greater extent than reducing cigarettes per day when both conditions were aided by nicotine patch. [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]

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 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]

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]

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]

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]

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]