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Aim To review randomized controlled trials to assess efficacy of a prize-based contingency management procedure in reducing substance use (where a drug-free breath or urine sample provides a chance of winning a prize). Methods A meta-analysis was conducted on papers published from January 2000 to February 2013 to determine the effect size of studies comparing prize-based contingency management to a treatment-as-usual control condition (k = 19 studies). Parallel analyses evaluated the efficacy of both short- (k = nine studies) and long-term outcomes (k = six studies) of prize-based contingency management. Results The average end-of-treatment effect size (Cohen’s d) was 0.46 [95% confidence interval (CI) = 0.37, 0.54]. This effect size decreased at the short-term (≤3-month) post-intervention follow-up to 0.33 (95% CI = 0.12, 0.54) and at the 6-month follow-up time-point there was no detectable effect [d = −0.09 (95% CI = −0.28, 0.10)]. Conclusion Adding prize-based contingency management to behavioral support for substance use disorders can increase short-term abstinence, but the effect does not appear to persist to 6 months. [ABSTRACT FROM AUTHOR]

Background and aims A chronic care strategy could potentially enhance the reach and effectiveness of smoking treatment by providing effective interventions for all smokers, including those who are initially unwilling to quit. This paper describes the conceptual bases of a National Cancer Institute-funded research program designed to develop an optimized, comprehensive, chronic care smoking treatment. Methods This research is grounded in three methodological approaches: (1) the Phase-Based Model, which guides the selection of intervention components to be experimentally evaluated for the different phases of smoking treatment (motivation, preparation, cessation, and maintenance); (2) the Multiphase Optimization Strategy (MOST), which guides the screening of intervention components via efficient experimental designs and, ultimately, the assembly of promising components into an optimized treatment package; and (3) pragmatic research methods, such as electronic health record recruitment, that facilitate the efficient translation of research findings into clinical practice. Using this foundation and working in primary care clinics, we conducted three factorial experiments (reported in three accompanying papers) to screen 15 motivation, preparation, cessation and maintenance phase intervention components for possible inclusion in a chronic care smoking treatment program. Results This research identified intervention components with relatively strong evidence of effectiveness at particular phases of smoking treatment and it demonstrated the efficiency of the MOST approach in terms both of the number of intervention components tested and of the richness of the information yielded. Conclusions A new, synthesized research approach efficiently evaluates multiple intervention components to identify promising components for every phase of smoking treatment. Many intervention components interact with one another, supporting the use of factorial experiments in smoking treatment development. [ABSTRACT FROM AUTHOR]

Background and Aims It has been proposed that more use should be made of Bayes factors in hypothesis testing in addiction research. Bayes factors are the ratios of the likelihood of a specified hypothesis (e.g. an intervention effect within a given range) to another hypothesis (e.g. no effect). They are particularly important for differentiating lack of strong evidence for an effect and evidence for lack of an effect. This paper reviewed randomized trials reported in Addiction between January and June 2013 to assess how far Bayes factors might improve the interpretation of the data. Methods Seventy-five effect sizes and their standard errors were extracted from 12 trials. Seventy-three per cent ( n = 55) of these were non-significant (i.e. P > 0.05). For each non-significant finding a Bayes factor was calculated using a population effect derived from previous research. In sensitivity analyses, a further two Bayes factors were calculated assuming clinically meaningful and plausible ranges around this population effect. Results Twenty per cent ( n = 11) of the non-significant Bayes factors were < ⅓ and 3.6% ( n = 2) were > 3. The other 76.4% ( n = 42) of Bayes factors were between ⅓ and 3. Of these, 26 were in the direction of there being an effect (Bayes factor > 1 and < 3); 12 tended to favour the hypothesis of no effect (Bayes factor < 1 and > ⅓); and for four there was no evidence either way (Bayes factor = 1). In sensitivity analyses, 13.3% of Bayes Factors were < ⅓ ( n = 20), 62.7% ( n = 94) were between ⅓ and 3 and 24.0% ( n = 36) were > 3, showing good concordance with the main results. Conclusions Use of Bayes factors when analysing data from randomized trials of interventions in addiction research can provide important information that would lead to more precise conclusions than are obtained typically using currently prevailing methods. [ABSTRACT FROM AUTHOR]

Background and Aims: Recovery management checkups (RMC) have established efficacy for linking patients to substance use disorder (SUD) treatment. This study tested whether using RMC in combination with screening, brief intervention, and referral to treatment (SBIRT), versus SBIRT alone, can improve linkage of primary care patients referred to SUD treatment. Design: A randomized controlled trial of SBIRT as usual (n = 132) versus SBIRT plus recovery management checkups for primary care (RMC‐PC) (n = 134) with follow‐up assessments at 3 months post‐baseline. Setting: Four federally qualified health centers in the United States serving low‐income populations. Participants: Primary care patients (n = 266, 64% male, 80% Black, mean age, 48.3 [range, 19–53]) who were referred to SUD treatment after SBIRT. Interventions: SBIRT alone (control condition) compared with SBIRT + RMC‐PC (experimental condition). Measurement The primary outcome was any days of SUD treatment in the past 3 months. Key secondary outcomes were days of SUD treatment overall and by level of care, days of alcohol and other drug (AOD) abstinence, and days of using specific substances, all based on self‐report. Findings At 3‐month follow‐up, those assigned to SBIRT + RMC‐PC (n = 134) had higher odds of receiving any SUD treatment (46% vs 20%; adjusted odds ratio = 4.50 [2.49, 8.48]) compared with SBIRT only, including higher rates of entering residential and intensive outpatient treatment. They also reported more days of treatment (14.45, vs 7.13; d = +0.26), more days abstinent (41.3 vs 31.9; d = +0.22), and fewer days of using alcohol (27.14, vs 36.31; d = −0.25) and cannabis (19.49, vs 28.6; d = −0.20). Conclusions: Recovery management checkups in combination with screening, brief intervention, and referral to treatment are an effective strategy for improving linkage of primary care patients in need to substance use disorder treatment over 3 months. [ABSTRACT FROM AUTHOR]

Background and aims Contingency management (CM) is one of the most effective behavioral interventions to promote drug abstinence, but availability of this treatment is limited. We evaluated the efficacy and acceptability of internet-based CM relative to an internet-based monitoring and goal-setting control group in a nationwide sample of cigarette smokers. Design Randomized controlled trial with 3- and 6-month follow-ups. Setting United States. Participants Smokers ( n = 94) from 26 states were enrolled (mean age 36, 56% female). Intervention and comparator Participants were randomized to earn financial incentives (up to $480 over 7 weeks) based on video-verified abstinence using breath carbon monoxide (CO) output ( n = 48; abstinent contingent group, AC), or based on submitting CO samples ( n = 46, submission contingent, SC). Both groups also received the same CO-based goals. A $50 deposit was required in both groups that could be recouped from initial earnings. Measures The primary outcome was point prevalence at week 4. Secondary outcomes were point prevalence at the 3- and 6-month follow-ups, percentages of negative CO samples, adherence to the CO sampling protocol, and treatment acceptability ratings on a 0-100-mm visual analog scale. Findings Abstinence rates differed at 4 weeks between the AC (39.6%) and SC (13.0%) groups [odds ratio (OR) = 4.4, 95% confidence interval (CI) = 1.6-12.3], but not at the 3- (29.2% AC and 19.6% SC, OR = 1.7, 95% CI = 0.6-4.4) or 6- (22.9% AC and 13.0% SC, OR = 2.0, 95% CI = 0.7-5.9) month follow-ups. During the two main treatment phases, there were significant differences in negative COs (53.9% AC and 24.8% SC, OR = 3.5, 95% CI = 3.1-4.0; 43.4% AC and 24.6% SC, OR = 2.3, 95% CI = 1.6-3.4). Adherence to the CO submission protocol was equivalent (78% AC and 85% SC, difference = 7.0%, 95% CI = −10.3 to 23.8 %, F < 1, P = 0.39). The lowest acceptability ratings were for the items assessing the deposit, whereas the highest ratings concerned the ease of the intervention, the graph of CO results, and earning money. Conclusions A contingency management/financial incentive program delivered via the internet improved short-term abstinence rates compared with an internet program without the incentives. [ABSTRACT FROM AUTHOR]

Background and Aims Naloxone is an opioid antagonist used for emergency resuscitation following opioid overdose. Prisoners with a history of heroin injection have a high risk of drug-related death soon after release from prison. The NALoxone InVEstigation (N-ALIVE) pilot trial (ISRCTN34044390) tested feasibility measures for randomized provision of naloxone-on-release (NOR) to eligible prisoners in England. Design. Parallel-group randomized controlled pilot trial. Setting English prisons. Participants A total of 1685 adult heroin injectors, incarcerated for at least 7 days pre-randomization, release due within 3 months and more than 6 months since previous N-ALIVE release. Intervention Using 1 : 1 minimization, prisoners were randomized to receive on release a pack containing either a single 'rescue' injection of naloxone or a control pack with no syringe. Measurements Key feasibility outcomes were tested against prior expectations: on participation (14 English prisons; 2800 prisoners), consent (75% for randomization), returned prisoner self-questionnaires (RPSQs: 207), NOR-carriage (75% in first 4 weeks) and overdose presence (80%). Findings Prisons (16) and prisoners (1685) were willing to participate [consent rate, 95% confidence interval (CI) = 70-74%]; 218 RPSQs were received; NOR-carriage (95% CI = 63-79%) and overdose presence (95% CI = 75-84%) were as expected. We randomized 842 to NOR and 843 to control during 30 months but stopped early, because only one-third of NOR administrations were to the ex-prisoner. Nine deaths within 12 weeks of release were registered for 1557 randomized participants released before 9 December 2014. Conclusions Large randomized trials are feasible with prison populations. Provision of take-home emergency naloxone prior to prison release may be a life-saving interim measure to prevent heroin overdose deaths among ex-prisoners and the wider population. [ABSTRACT FROM AUTHOR]

Aims To compare the use of alternative nicotine products, smoking behavior and tobacco biomarker exposure in smokers unwilling to quit who were assigned randomly to normal nicotine content (NNC) cigarettes or very low nicotine content (VLNC) cigarettes. Design Randomized, parallel-arm 8-week study with assignment to VLNC (VLNC 1, n = 53) or NNC (NNC, n = 27) with access to non-cigarette combusted and non-combusted tobacco/nicotine products or to VLNC with access to only non-combusted products (VLNC2, n = 56). Setting Clinics in Minnesota, USA. Participants Smokers uninterested in quitting smoking with a mean [± standard deviation (SD)] age of 44 (± 14) years and smoking 16 (± seven) cigarettes/day; 51% female, 72% white. Measurements During the experimental period, the measures taken included: rate of alternative products used, amount of and abstinence from combusted tobacco used and tobacco exposure biomarkers. Findings There were higher rates of non-combusted alternative tobacco/nicotine product use in both VLNC conditions versus the NNC condition [rate ratio (RR) = 2.18, 95% confidence interval (CI) = 1.94, 2.46 and RR = 1.64, 95% CI = 1.46, 1.85, respectively] and in VLNC1 versus VLNC2 condition (RR = 1.33, 95% CI = 1.23, 1.44), accompanied by reduced biomarkers of exposure primarily in VLNC2 condition compared to NNC condition ( Ps < 0.05). Fewer combusted products were smoked at almost all visits ( Ps ≤ 0.02) and there were higher rates of abstinence for both VLNC conditions compared with the NNC condition (VLNC1 versus NNC: RR = 9.96, 95% CI = 5.01, 19.81; VLNC2 versus NNC: RR = 11.23, 95% CI = 5.74, 21.97). Conclusion The offer of, and instructions to use, reduced nicotine content cigarettes during an 8-week period led to greater use of alternative tobacco/nicotine products compared with continued use of normal nicotine cigarettes and also reductions in smoking rates. [ABSTRACT FROM AUTHOR]

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

Aims We tested two aims: (1) the teachable moment (TM): whether second-hand smoke exposure (SHSe) feedback motivates cessation in parents of children with asthma versus parents of healthy children (HC); and (2) whether greater intervention intensity [enhanced-precaution adoption model (PAM)] produces greater cessation than a previously tested intervention (PAM). Design and interventions Aim 1: two home visits (asthma education or child wellness), and cessation induction using motivational interviewing and SHSe feedback. Aim 2: post-home-visits, parents with asthmatic children were randomized to PAM (n = 171; six asthma education calls) or enhanced-PAM (n = 170; six asthma education/smoking cessation calls + repeat SHSe feedback). Setting Rhode Island, USA. Participants Parents of asthmatic (n = 341) or healthy (n = 219) children who did not have to want to quit smoking to enroll. Measurements Measurements were given at baseline, 2, 4, 6 and 12 months. Abstinence was bioverified. Outcomes were 7-day and 30-day point prevalence abstinence (ppa) and SHSe (primary) and asthma morbidity (secondary). Findings Aim 1: the TM was supported: parents of asthmatic children were more than twice as likely to achieve 30-day [odds ratio (OR) = 2.60, 95% confidence interval (CI) = 1.22-5.54] and 7-day ppa (OR = 2.26, 95% CI = 1.13-4.51) at 2 months (primary end-point) and have non-detectable levels of SHSe than HCs. Greater treatment intensity yielded stronger TM effects (OR = 3.60; 95% CI = 1.72-7.55). Aim 2: enhanced-PAM was more likely to achieve 30-day ppa at the primary end-point, 4 months (OR = 2.12, 95% CI 1.09-4.12) and improved asthma outcomes versus PAM. Conclusions Smoking cessation intervention (Motivational Interviewing plus biomarker feedback) appear to motivate smoking cessation more strongly among parents of asthmatic children than among parents of healthy children. Increased intervention intensity yields greater smoking cessation among parents of asthmatic children and better asthma outcomes. [ABSTRACT FROM AUTHOR]

Aims To determine whether the provision of contingencymanagement using financial incentives to improve hepatitis B vaccine completion in people who inject drugs entering community treatment represents a cost-effective use of healthcare resources. Design A probabilistic cost-effectiveness analysis was conducted, using a decision-tree to estimate the short-term clinical and health-care cost impact of the vaccination strategies, followed by a Markov process to evaluate the long-term clinical consequences and costs associated with hepatitis B infection. Settings and participants Data on attendance to vaccination from a UK cluster randomized trial. Intervention Two contingency management options were examined in the trial: fixed versus escalating schedule financial incentives. Measurement Life-time health-care costs and quality-adjusted life years discounted at 3.5% annually; incremental cost-effectiveness ratios. Findings The resulting estimate for the incremental life-time health-care cost of the contingency management strategy versus usual care was £21.86 [95% confidence interval (CI) = -£12.20 to 39.86] per person offered the incentive. For 1000 people offered the incentive, the incremental reduction in numbers of hepatitis B infections avoided over their lifetime was estimated at 19 (95% CI = 8-30). The probabilistic incremental cost per quality adjusted life-year gained of the contingency management programmewas estimated to be £6738 (95% CI = £6297-7172),with an 89% probability of being considered cost-effective at a threshold of £20 000 per quality-adjusted life years gained (97.60% at £30 000). Conclusions Using financial incentives to increase hepatitis B vaccination completion in people who inject drugs could be a cost-effective use of health-care resources in the UK as long as the incidence remains above 1.2%. [ABSTRACT FROM AUTHOR]

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

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

Background and Aims While there is broad recognition of the high societal costs of substance use disorders (SUD), treatment rates are low. We examined whether, in the United States, participants with substance or alcohol use disorder would report a greater willingness to enter SUD treatment located in a primary care setting (primary care) or more commonly found specialty care setting in the United States (usual care). Design Randomized survey-embedded experiment. Setting US web-based research panel in which participants were randomized to read one-paragraph vignettes describing treatment in usual care (specialty drug or alcohol treatment center), primary care or collaborative care within a primary care setting. Participants A total of 42 451 panelists aged 18+ were screened for substance or alcohol use disorder using validated diagnostic criteria. Participants included 344 with a substance use disorder and 634 with an alcohol use disorder not in treatment with no prior treatment history. Measures Willingness to enter treatment across vignettes by condition. Findings Among participants with a substance use disorder, 24.6% of those randomized to usual care reported being willing to enter drug treatment compared with 37.2% for primary care [12.6 percentage point difference; 95% confidence interval (CI) = 0.8, 24.4) and 34.0% for collaborative care (9.4 percentage point difference; 95% CI = -2.0, 20.8). Among participants with an alcohol use disorder, 17.6% of those randomized to usual care reported being willing to enter alcohol treatment compared with 20.3% for primary care (2.6 percentage point difference; 95% CI = -4.9, 10.1) and 20.8% for collaborative care (3.1 percentage point difference; 95% CI = -4.3, 10.6). The most common reason for not being willing to enter drug (63%) and alcohol (78%) treatment was the belief that treatment was not needed. Conclusions In the United States, people diagnosed with substance or alcohol use disorders appear to be more willing to enter treatment in a primary care setting than in a specialty drug treatment center. Expanding availability of primary care-based substance use disorder treatment could increase treatment rates in the United States. [ABSTRACT FROM AUTHOR]

Background and Aims Previous studies have reported that people who use a smoking cessation medication while smoking and reduce cigarette consumption spontaneously are three times more likely to stop smoking after a quit date. The aim was to replicate this and assess whether it arises because of willed effortful reduction rather than unwilled reduced drive to smoke caused by medication. Design Secondary analysis of a trial where participants were randomised to smoke as normal or reduce by 75% over 2 weeks prior to quit date, using nicotine replacement therapy (NRT) in both arms. Setting Thirty-one UK primary care practices. Participants A total of 517 adult smokers seeking quitting support in the carbon monoxide (CO) analyses and 421 in the cigarettes/day analyses. Measurements Russell Standard abstinence was recorded 4 weeks after quit date. The randomized groups were combined and the association between reduction and abstinence examined. The second analysis assessed whether this association differed by whether smokers were, or were not, instructed to reduce. Findings In all participants, there was no evidence that reducing cigarettes/day or CO by at least half compared with not reducing predicted abstinence at 4 weeks [risk ratio (RR) = 0.88; 95% confidence interval (CI) = 0.68-1.14 and RR = 1.20; 95% CI = 1.00-1.44, respectively]. However, in smokers instructed to reduce, CO reduction was associated with 4-week abstinence (RR = 1.52; 95% CI = 1.16-2.00), but not among people advised not to reduce (RR = 0.91; 95% CI = 0.67-1.24). Conclusions Smoking reduction prior to a target quit date while on a smoking cessation medication may only predict subsequent abstinence when smokers are consciously attempting to reduce. [ABSTRACT FROM AUTHOR]

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

Aims Syringe exchange has been suggested as a potential conduit to treatment for drug dependence, but this has never been documented in Europe. The primary aim was to compare the effectiveness of strength-based case management intervention (CMI) against referral only to facilitate treatment attendance in a syringe exchange programme. We also assessed the effectiveness of a syringe exchange programme for referral of heroin-dependent patients to evidence-based treatment with methadone or buprenorphine (buprenorphine-naloxone). Design Single-site, two-group randomized controlled trial. Setting The syringe exchange programme in Malmö, Sweden and an out-patient clinic (research treatment facility) for maintenance treatment, situated outside the hospital area and run by Malmö Addiction Centre. Participants Heroin-dependent patients willing to participate ( n = 75) were referred to maintenance treatment and randomized to either a strength-based case management intervention aiming to facilitate referral ( n = 36) or to referral-only ( n = 39). Intervention The intervention group received an appointment for maintenance treatment and a CMI adjusted to individual patient needs. The CMI was semi-structured, assessing the patients' strengths and needs and identifying what practical help they might need to get to the appointment for maintenance treatment. The control group received an appointment for maintenance treatment. Measures The primary outcome was treatment entry. Findings Among patients who turned up for recruitment interview and randomization, the percentage of patients who started treatment was 95% in the intervention group and 94% in the control group. Treatment entry was unrelated to intervention status [unadjusted odds ratio (OR) = 0.92 (0.12-6.89), P = 1.00 and adjusted OR = 0.96 (0.12-7.83)]. Conclusions A randomized controlled trial in a syringe exchange programme showed no evidence that a strength-based case management intervention improved attendance for treatment over referral alone. Attendance rates were high in both groups. [ABSTRACT FROM AUTHOR]

Aims To screen promising intervention components designed to reduce smoking and promote abstinence in smokers initially unwilling to quit. Design A balanced, four-factor, randomized factorial experiment. Setting Eleven primary care clinics in southern Wisconsin, USA. Participants A total of 517 adult smokers (63.4% women, 91.1% white) recruited during primary care visits who were willing to reduce their smoking but not quit. Interventions Four factors contrasted intervention components designed to reduce smoking and promote abstinence: (1) nicotine patch versus none; (2) nicotine gum versus none; (3) motivational interviewing (MI) versus none; and (4) behavioral reduction counseling (BR) versus none. Participants could request cessation treatment at any point during the study. Measurements The primary outcome was percentage change in cigarettes smoked per day at 26 weeks post-study enrollment; the secondary outcomes were percentage change at 12 weeks and point-prevalence abstinence at 12 and 26 weeks post-study enrollment. Findings There were few main effects, but a significant four-way interaction at 26 weeks post-study enrollment ( P = 0.01, β = 0.12) revealed relatively large smoking reductions by two component combinations: nicotine gum combined with BR and BR combined with MI. Further, BR improved 12-week abstinence rates ( P = 0.04), and nicotine gum, when used without MI, increased 26-week abstinence after a subsequent aided quit attempt ( P = 0.01). Conclusions Motivation-phase nicotine gum and behavioral reduction counseling are promising intervention components for smokers who are initially unwilling to quit. [ABSTRACT FROM AUTHOR]

Aim s To identify promising intervention components intended to help smokers to attain and maintain abstinence in their quit smoking attempts. Design A fully crossed, six-factor randomized fractional factorial experiment. Setting Eleven primary care clinics in southern Wisconsin, USA. Participants A total of 637 adult smokers (55% women, 88% white) motivated to quit smoking who visited primary care clinics. Interventions Six intervention components designed to prepare smokers to quit, and achieve and maintain abstinence (i.e. for the preparation, cessation and maintenance phases of smoking treatment): (1) preparation nicotine patch versus none; (2) preparation nicotine gum versus none; (3) preparation counseling versus none; (4) intensive cessation in-person counseling versus minimal; (5) intensive cessation telephone counseling versus minimal; and (6) 16 versus 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine gum). Measurements Seven-day self-reported point-prevalence abstinence at 16 weeks. Findings Preparation counseling significantly improved week 16 abstinence rates ( P = .04), while both forms of preparation nicotine replacement therapy interacted synergistically with intensive cessation in-person counseling ( P < 0.05). Conversely, intensive cessation phone counseling and intensive cessation in-person counseling interacted antagonistically ( P < 0.05)-these components produced higher abstinence rates by themselves than in combination. Conclusions Preparation counseling and the combination of intensive cessation in-person counseling with preparation nicotine gum or patch are promising intervention components for smoking and should be evaluated as an integrated treatment package. [ABSTRACT FROM AUTHOR]

Aims To identify promising intervention components that help smokers attain and maintain abstinence during a quit attempt. Design A 2 × 2 × 2 × 2 × 2 randomized factorial experiment. Setting Eleven primary care clinics in Wisconsin, USA. Participants A total of 544 smokers (59% women, 86% white) recruited during primary care visits and motivated to quit. Interventions Five intervention components designed to help smokers attain and maintain abstinence: (1) extended medication (26 versus 8 weeks of nicotine patch + nicotine gum); (2) maintenance (phone) counseling versus none; (3) medication adherence counseling versus none; (4) automated (medication) adherence calls versus none; and (5) electronic medication monitoring with feedback and counseling versus electronic medication monitoring alone. Measurements The primary outcome was 7-day self-reported point-prevalence abstinence 1 year after the target quit day. Findings Only extended medication produced a main effect. Twenty-six versus 8 weeks of medication improved point-prevalence abstinence rates (43 versus 34% at 6 months; 34 versus 27% at 1 year; P = 0.01 for both). There were four interaction effects at 1 year, showing that an intervention component's effectiveness depended upon the components with which it was combined. Conclusions Twenty-six weeks of nicotine patch + nicotine gum (versus 8 weeks) and maintenance counseling provided by phone are promising intervention components for the cessation and maintenance phases of smoking treatment. [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]

Aim To evaluate the effectiveness of a nurse intervention aimed at helping college student smokers quit smoking. Design Single-blind, pragmatic randomized controlled trial which compares a multi-component intervention, tailored specifically to college students, with a brief advice session with a 6-month follow-up. Settings This study was conducted at the University of Navarra, Spain. Participants A total of 255 college student smokers (age range = 18-24 years) were randomized to an intervention group ( n = 133) or to a control group ( n = 122). Intervention A multi-component intervention based on the Theory of Triadic Influence of Flay was developed. The intervention consisted of a 50-minute motivational interview conducted by a nurse and online self-help material. The follow-up included a reinforcing e-mail and group therapy. Measurements The primary outcome was self-reported abstinence, with biochemical verification at 6 months. The secondary outcomes consisted of the mean number of cigarettes smoked per day, self-reported attempts to quit smoking and stage of change at 6 months. Findings At the 6-month follow-up, the smoking cessation incidence was 21.1% in the intervention group compared with 6.6% in the control group (difference = 14.5 confidence interval = 6.1-22.8; relative risk = 3.41, 95% confidence interval = 1.62-7.20). The difference in the mean number of cigarettes at 6 months was significantly different (difference = -2.2, confidence interval = -3.6 to -0.9). Conclusions A multi-component intervention tailored to college students and managed by a nurse is effective in increasing smoking cessation among college students. [ABSTRACT FROM AUTHOR]

Background and Aims A broadly mandated reduction of the nicotine content (RNC) of cigarettes has been proposed in the United States to reduce the addictiveness of cigarettes, to prevent new smokers from becoming addicted and to facilitate quitting in established smokers. The primary aim of this study was to determine whether following 7 months of smoking very low nicotine content cigarettes (VLNC), and then returning to their own cigarettes, smokers would demonstrate persistently reduced nicotine intake compared with baseline or quit smoking. Methods In a community-based clinic 135 smokers not interested in quitting were randomized to one of two groups. A research group smoked their usual brand of cigarettes, followed by five types of research cigarettes with progressively lower nicotine content, each for 1 month, followed by 6 months at the lowest nicotine level (0.5 mg/cigarette) (53 subjects) and then 12 months with no intervention (30 subjects completed). A control group smoked their usual brand for the same period of time (50 subjects at 6 months, 38 completed). Smoking behavior, biomarkers of nicotine intake and smoke toxicant exposure were measured. Results After 7 months smoking VLNC, nicotine intake remained below baseline (plasma cotinine 149 versus 250 ng/ml, P<0.005) with no significant change in cigarettes per day or expired carbon monoxide (CO). During the 12-month follow-up, cotinine levels in RNC smokers rose to baseline levels and to those of control smokers. Quit rates among RNC smokers were very low [7.5 versus 2% in controls, not significant). Conclusions In smokers not interested in quitting, reducing the nicotine content in cigarettes over 12 months does not appear to result in extinction of nicotine dependence, assessed by persistently reduced nicotine intake or quitting smoking over the subsequent 12 months. [ABSTRACT FROM AUTHOR]

Aims To examine the effectiveness of a personality-targeted intervention program (Adventure trial) delivered by trained teachers to high-risk (HR) high-school students on reducing marijuana use and frequency of use. Design A cluster-randomized controlled trial. Setting Secondary schools in London, UK. Participants Twenty-one secondary schools were randomized to intervention ( n = 12) or control ( n = 9) conditions, encompassing a total of 1038 HR students in the ninth grade [mean (standard deviation) age = 13.7 (0.33) years]. Interventions Brief personality-targeted interventions to students with one of four HR profiles: anxiety sensitivity, hopelessness, impulsivity and sensation-seeking. Measurements Primary outcome: marijuana use. Secondary outcome: frequency of use. Assessed using the Reckless Behaviour Questionnaire at intervals of 6 months for 2 years. Personality risk was measured with the Substance Use Risk Profile Scale. Findings Logistic regression analysis revealed significant intervention effects on cannabis use rates at the 6-month follow-up in the intent-to-treat sample [odds ratio (OR) = 0.67, P = 0.05, 95% confidence interval (CI) = 0.45-1.0] and significant reductions in frequency of use at 12- and 18-month follow-up (β = -0.14, P ≤ 0.05, 95% CI = -0.6 to -0.01; β = -0.12, P ≤ 0.05, 95% CI = -0.54 to 0.0), but this was not supported in two-part latent growth models. Subgroup analyses (both logistic and two-part models) reveal that the sensation-seeking intervention delayed the onset of cannabis use among sensation seekers (OR = 0.25, β = -0.833, standard error = 0.342, P = 0.015). Conclusions Personality-targeted interventions can be delivered effectively by trained school staff to delay marijuana use onset among a subset of high-risk teenagers: sensation-seekers. [ABSTRACT FROM AUTHOR]

Aims The extent of variation attributable to regional differences for the efficacy of brief intervention (BI) to reduce hazardous and harmful alcohol consumption is unclear. The primary aim of this study was to determine overall efficacy of BI at 6- and 12-month follow-up in primary health care (PHC) and emergency department (ED) studies. The secondary aim was to examine whether variance in study outcome can be explained by the geographical region in which trials have taken place (European versus non-European). Methods A systematic review and meta-analysis of randomized controlled trials (RCTs) published before August 2014 was undertaken. Twenty RCTs conducted in PHC settings with a total of 8226 participants (European = 4564/non-European = 3662) and eight RCTs conducted in ED settings with a total of 4799 participants (European = 2465/non-European = 2334) were eligible. Primary outcome measure was reduction in grams of alcohol consumed per week for BI and control groups at 6- and 12-month follow-up. An inverse variance model was applied to measure the effect of treatment in mean differences for BI and control groups at 6- and 12-month follow-up. Variance between study outcomes was explored using subgroup analysis of European versus non-European countries. Results For PHC trials at 6-month follow-up, statistically significant benefits of BI were indicated [mean difference (MD) = −21.98 g/week; 95% confidence interval (CI) = −37.40 to −6.57; P = 0.005]. At 12-month follow-up, statistically significant benefit of BI was evident (MD = −30.86 g/week; 95% CI = −46.49 to −15.23; P = 0.0001). For ED trials at 6-month follow-up, statistically significant benefits of BI were indicated (MD = −17.97 g/week; 95% CI = −29.69 to −6.24; P = 0.003). At 12-month follow-up, statistically significant benefit in favour of BI was evident (MD = −18.21 g/week; 95% CI = −26.71 to −9.70; P < 0.0001). No statistically significant differences were detected in subgroup analyses of outcomes for European versus non-European studies. Conclusions Brief intervention (BI) to reduce alcohol consumption is associated with reducing grams of alcohol consumed per week among hazardous and harmful drinkers at 6- and 12-month follow-up in primary health care and emergency department trials. The geographical region in which trials are undertaken does not appear to explain the variance in trial outcomes for reducing alcohol consumption. [ABSTRACT FROM AUTHOR]

Aim The effectiveness of Preventure was tested on drinking behaviour of young adolescents in secondary education in the Netherlands. Design A cluster randomized controlled trial was carried out, with participants assigned randomly to a two-session coping skills intervention or a control no-intervention condition. Setting Fifteen secondary schools throughout the Netherlands; seven schools in the intervention and eight schools in the control condition. Participants A total of 699 adolescents aged 13-15 years participated, 343 allocated to the intervention and 356 to the control condition, with drinking experience and elevated scores in either negative thinking, anxiety sensitivity, impulsivity or sensation-seeking. Intervention and comparator Preventure is a selective school-based alcohol prevention programme targeting personality risk factors. The comparator was a no-intervention control. Measurements The effects of the intervention on the primary outcome past-month binge drinking, and the secondary outcomes binge drinking frequency, alcohol use, alcohol frequency and problem drinking, were examined. The primary analyses of interest were intervention main effects at 12 months post-intervention. In addition, intervention effects on the linear development of binge drinking using a latent-growth curve approach were examined. Findings Binge drinking rates were not significantly different between the intervention (42.9%) and control group (49.2%) at 12 months follow-up [odds ratio (OR) = 1.05, confidence interval (CI) = 0.99, 1.11]. Intention-to-treat analyses revealed no significant intervention effects on alcohol use (53.9 versus 61.5%; OR = 0.99, CI = 0.86, 1.14) and problem drinking (37.0 versus 44.7%; OR = 1.03, CI = 0.92, 1.10) at 12 months follow-up. The post-hoc latent-growth analyses revealed significant effects on the development of binge drinking ( β = -0.16, P = 0.05), and binge drinking frequency ( β = -0.14, P = 0.05). Conclusion The alcohol prevention programme, Preventure, appears to have little or no effect on overall prevalence of binge drinking in adolescents in the Netherlands but may reduce the development of binge drinking over time. [ABSTRACT FROM AUTHOR]

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

Aims Within a parent study examining ovarian hormone effects on smoking cessation in women, we conducted an exploratory short-term trial of varenicline versus transdermal nicotine patch. Design Double-blind double-dummy randomized trial. Setting Single-site out-patient research clinic in the United States. Participants Female smokers, ages 18-45 years and averaging ≥10 cigarettes per day for at least 6 months ( n = 140). Interventions Participants were randomized to receive a 4-week course of (a) varenicline tablets and placebo patches ( n = 67) or (b) placebo tablets and nicotine patches ( n = 73). Two brief cessation counseling sessions were provided for all participants. Measurements The outcome of primary clinical interest was 2-week end-of-treatment abstinence. Secondary outcomes included 1- and 4-week end-of treatment abstinence and abstinence at a post-treatment follow-up visit occurring 4 weeks after treatment conclusion. Breath carbon monoxide (≤ 10 parts per million) was used to confirm biochemically self-reported abstinence. Findings Two-week end-of-treatment abstinence was achieved by 37.3% (25 of 67) of varenicline participants and by 17.8% (13 of 73) of nicotine patch participants [odds ratio (OR) = 2.7, 95% confidence interval (CI) = 1.3-6.0, P = 0.011]. One-week (44.8 versus 20.6%, OR = 3.1, 95% CI = 1.5-6.6, P = 0.003) and 4-week (22.4 versus 9.6%, OR = 2.7, 95% CI = 1.0-7.2, P = 0.043) end-of-treatment abstinence similarly favored varenicline, although post-treatment follow-up Russell Standard abstinence was not significantly different between groups (23.9 versus 13.7%, OR = 2.0, 95% CI = 0.8-4.7, P = 0.126). Conclusion In an exploratory 4-week head-to-head trial in female smokers, varenicline, compared with nicotine patch, more than doubled the odds of end-of-treatment abstinence, although this diminished somewhat at post-treatment follow-up. [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]

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

Aims To determine the efficacy of motivational enhancement therapy (MET) on alcohol use in patients with the hepatitis C virus ( HCV) and an alcohol use disorder ( AUD). Design Randomized, single-blind, controlled trial comparing MET to a control education condition with 6-month follow-up. Setting Patients were recruited from hepatitis clinics at the Minneapolis, Minnesota and Portland, Oregon Veterans Affairs Health Care Systems, USA. Participants and Intervention Patients with HCV, an AUD and continued alcohol use ( n = 139) were randomized to receive either MET ( n = 70) or a control education condition ( n = 69) over 3 months. Measurements Data were self-reported percentage of days abstinent from alcohol and number of standard alcohol drinks per week 6 months after randomization. Findings At baseline, subjects in MET had 34.98% days abstinent, which increased to 73.15% at 6 months compared to 34.63 and 59.49% for the control condition. Multi-level models examined changes in alcohol consumption between MET and control groups. Results showed a significant increase in percentage of days abstinent overall ( F(1120.4) = 28.04, P < 0.001) and a significant group × time effect ( F(1119.9) = 5.23, P = 0.024) with the MET group showing a greater increase in percentage of days abstinent at 6 months compared with the education control condition. There were no significant differences between groups for drinks per week. The effect size of the MET intervention was moderate (0.45) for percentage of days abstinent. Conclusion Motivational enhancement therapy ( MET) appears to increase the percentage of days abstinent in patients with chronic hepatitis C, alcohol use disorders and ongoing alcohol use. [ABSTRACT FROM AUTHOR]