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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]

Aims This study examines the preliminary outcomes of an intervention targeting service providers in methadone maintenance therapy ( MMT) clinics in China. The intervention effects on both service providers and clients are reported. Design The MMT CARE intervention pilot was developed and implemented collaboratively with local health educators. After three group intervention sessions, trained providers in intervention clinics delivered two individual motivational interviewing sessions with their clients. Settings Six clinics in Sichuan, China, were randomized to either the MMT CARE intervention condition or a standard care condition. Participants A total of 41 providers and 179 clients were sampled from the six clinics. Measurements At baseline and three-, six-, and nine-month assessments, providers completed self-administrated paper/pencil questionnaires regarding provider-client interaction, MMT knowledge, perceived job-related stigma and clinic support. Clients completed a face-to-face survey about their concurrent drug use and drug avoidance self-efficacy. Mixed-effects regression models with clinic-level random effect were used to assess the intervention effects. Findings Significant intervention effects for providers were found in improved MMT knowledge, provider-client interaction and perceived clinic support. For clients, better improvements in drug avoidance self-efficacy and reduced concurrent drug use were observed for the intervention compared with the standard care group. Conclusions The MMT CARE intervention targeting providers in methadone maintenance clinics can improve providers' treatment knowledge and their interaction with clients. The intervention can also reduce clients' drug-using behavior through motivational interviewing sessions conducted by trained providers. [ABSTRACT FROM AUTHOR]

Aims This paper reviews the published literature regarding outcomes following maternal treatment with buprenorphine in five areas: maternal efficacy, fetal effects, neonatal effects, effects on breast milk and longer-term developmental effects. Methods Within each outcome area, findings are summarized first for the three randomized clinical trials and then for the 44 non-randomized studies (i.e. prospective studies, case reports and series and retrospective chart reviews), only 28 of which involve independent samples. Results Results indicate that maternal treatment with buprenorphine has comparable efficacy to methadone, although difficulties may exist with current buprenorphine induction methods. The available fetal data suggest buprenorphine results in less physiological suppression of fetal heart rate and movements than methadone. Regarding neonatal effects, perhaps the single definitive conclusion is that prenatal buprenorphine treatment results in a clinically significant less severe neonatal abstinence syndrome ( NAS) than treatment with methadone. The limited research suggests that, like methadone, buprenorphine is compatible with breastfeeding. Data available thus far suggest that there are no deleterious effects of in utero buprenorphine exposure on infant development. Conclusions While buprenorphine produces a less severe neonatal abstinence syndrome than methadone, both methadone and buprenorphine are important parts of a complete comprehensive treatment approach for opioid-dependent pregnant women. [ABSTRACT FROM AUTHOR]

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

Background and Aims: Treatment of depression‐related psychological factors related to smoking behavior may improve rates of cessation among adults with major depressive disorder (MDD). This study measured the efficacy and safety of 12 weeks of behavioral activation for smoking cessation (BASC), varenicline and their combination. Design, Setting, Participants: This study used a randomized, placebo‐controlled, 2 × 2 factorial design comparing BASC versus standard behavioral treatment (ST) and varenicline versus placebo, taking place in research clinics at two urban universities in the United States. Participants comprised 300 hundred adult smokers with current or past MDD. Interventions: BASC integrated behavioral activation therapy and ST to increase engagement in rewarding activities by reducing avoidance, withdrawal and inactivity associated with depression. ST was based on the 2008 PHS Clinical Practice Guideline. Both treatments consisted of eight 45‐min sessions delivered between weeks 1 and 12. Varenicline and placebo were administered for 12 weeks between weeks 2 and 14. Measurements: Primary outcomes were bioverified intent‐to‐treat (ITT) 7‐day point‐prevalence abstinence at 27 weeks and adverse events (AEs). Findings No significant interaction was detected between behavioral treatment and pharmacotherapy at 27 weeks (χ2(1) = 0.19, P = 0.67). BASC and ST did not differ (χ2(1) = 0.43, P = 0.51). Significant differences in ITT abstinence rates (χ2(1) = 4.84, P = 0.03) emerged among pharmacotherapy arms (16.2% for varenicline, 7.5% for placebo), with results favoring varenicline over placebo (rate ratio = 2.16, 95% confidence interval = 1.08, 4.30). All significant differences in AE rates after start of medication were higher for placebo than varenicline. Conclusion: A randomized trial in smokers with major depressive disorder found that varenicline improved smoking abstinence versus placebo at 27 weeks without elevating rates of adverse events. Behavioral activation for smoking cessation did not outperform standard behavioral treatment, with or without adjunctive varenicline therapy. [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]

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

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

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

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]

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]

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]

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]

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 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 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 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 To assess the effects of adding motivational interviewing ( MI) counseling to nicotine patch for smoking cessation among homeless smokers. Design Two-group randomized controlled trial with 26-week follow-up. Participants and setting A total of 430 homeless smokers from emergency shelters and transitional housing units in Minneapolis/ St Paul, Minnesota, USA. Intervention and measurements All participants received 8-week treatment of 21-mg nicotine patch. In addition, participants in the intervention group received six individual sessions of MI counseling which aimed to increase adherence to nicotine patches and to motivate cessation. Participants in the standard care control group received one session of brief advice to quit smoking. Primary outcome was 7-day abstinence from cigarette smoking at 26 weeks, as validated by exhaled carbon monoxide and salivary cotinine. Findings Using intention-to-treat analysis, verified 7-day abstinence rate at week 26 for the intervention group was non-significantly higher than for the control group (9.3% versus 5.6%, P = 0.15). Among participants who did not quit smoking, reduction in number of cigarettes from baseline to week 26 was equally high in both study groups (−13.7 ± 11.9 for MI versus −13.5 ± 16.2 for standard care). Conclusions Adding motivational interviewing counseling to nicotine patch did not increase smoking rate significantly at 26-week follow-up for homeless smokers. [ABSTRACT FROM AUTHOR]

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

Aims To test the population impact of offering automated smoking cessation interventions via the internet and/or by mobile phone. Design Pragmatic randomized controlled trial with five conditions: offer of (i) minimal intervention control; (ii) QuitCoach personalized tailored internet-delivered advice program; (iii) on Q, an interactive automated text-messaging program; (iv) an integration of both QuitCoach and on Q; and (v) a choice of either alone or the combined program. Setting Australia, via a mix of internet and telephone contacts. Participants A total of 3530 smokers or recent quitters recruited from those interested in quitting, and seeking self-help resources ( n = 1335) or cold-contacted from internet panels ( n = 2195). Measurements The primary outcome was self-report of 6 months sustained abstinence at 7 months post-recruitment. Findings Only 42.5% of those offered one of the interventions took it up to a minimal level. The intervention groups combined had a non-significantly higher 6-month sustained abstinence rate than the control [odds ratio ( OR) = 1.48; 95% confidence interval (CI): 0.98-2.24] (missing cases treated as smokers), with no differences between the interventions. Among those who used an intervention, there was a significant overall increase in abstinence ( OR = 1.95; CI: 1.04-3.67), but not clearly so when analysing only cases with reported outcomes. Success rates were greater among those recruited after seeking information compared to those cold-contacted. Conclusions Smokers interested in quitting who were assigned randomly to an offer of either the QuitCoach internet-based support program and/or the interactive automated text-messaging program had non-significantly greater odds of quitting for at least 6 months than those randomized to an offer of a simple information website. [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]

Aims To determine whether web-based tailored cessation advice, based on social cognitive theory and the perspectives on change model, was more effective in aiding a quit attempt than broadly similar web-based advice that was not tailored. Design Participants were allocated randomly to one of two groups, to receive either a cessation advice report and progress report that were tailored to individual-level characteristics or a cessation advice report that presented standardized (non-tailored) content. Tailoring was based on smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations. Setting Participant enrolment and baseline assessments were conducted remotely online via the study website, with the advice reports presented by the same website. Participants Participants ( n = 1758) were visitors to the QUIT website who were based in the United Kingdom, aged 18 years or over and who smoked cigarettes or hand-rolled tobacco. Measurements Follow-up assessments were made at 6 months by telephone interview. The primary outcome measure was self-reported 3 months prolonged abstinence, and secondary outcomes were 1 month prolonged abstinence, 7-day and 24-hour point prevalence abstinence. Findings The intervention group did not differ from the control group on the primary outcome (9.1% versus 9.3%; odds ratio = 1.02 95% confidence interval 0.73-1.42) or on any of the secondary outcomes. Intervention participants gave more positive evaluations of the materials than control participants. Conclusions A web-based intervention that tailored content according to smoking-related beliefs, personal characteristics and smoking patterns, self-efficacy and outcome expectations, was not more effective than web-based materials presenting broadly similar non-tailored information. [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]

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]

Aim To examine hepatic enzyme test results throughout the course of pregnancy in women maintained on methadone or buprenorphine. Design Participants were randomized to either methadone or buprenorphine maintenance. Blood chemistry tests, including liver transaminases and hepatitis C virus ( HCV) status, were determined every 4 weeks and once postpartum. As part of a planned secondary analysis, generalized mixed linear models were conducted with aspartate aminotransferase ( AST), alanine aminotransferase ( ALT) and gamma-glutamyl transferase ( GGT) as the dependent variables. Setting Six US sites and one European site that provided comprehensive treatment to pregnant opioid-dependent women. Participants A total of 175 opioid-dependent pregnant women enrolled in the Maternal Opioid Treatment: Human Experimental Research ( MOTHER) study. Findings ALT, AST and GGT levels decreased for all subjects across pregnancy trimesters, rising slightly postpartum. HCV-positive subjects exhibited higher transaminases at all time-points compared to HCV-negative subjects, regardless of medication (all Ps < 0.05) condition. Both HCV-positive and negative buprenorphine-maintained participants exhibited lower GGT levels than those who were methadone-maintained ( P < 0.05). Conclusions Neither methadone nor buprenorphine appear to have adverse hepatic effects in the treatment of pregnant opioid-dependent women. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims The purpose of the current study was to evaluate feasibility and efficacy of two promising approaches to indicated prevention of disordered gambling in a college population. Design Randomized clinical trial with assignment to a personalized feedback intervention (PFI), cognitive-behavioral intervention (CBI) or assessment-only control (AOC). PFI was delivered individually in a single session and included feedback regarding gambling behavior, norms, consequences and risk-reduction tips, delivered in a motivational interviewing style. CBI was delivered in small groups over four to six sessions and included functional analysis and brief cognitive correction, as well as identification of and alternatives for responding to gambling triggers. Setting College campus. Participants At-risk or probable pathological gamblers ( n = 147; 65.3% male; group assignment: PFI, n = 52; CBI, n = 44; AOC, n = 51). Measurements Self-reported gambling quantity, frequency, consequences, psychopathology, normative perceptions and beliefs. Findings Relative to control, results at 6-month follow-up indicated reductions in both interventions for gambling consequences (PFI d = 0.48; CBI d = 0.39) and DSM-IV criteria (PFI d = 0.60; CBI d = 0.48), reductions in frequency for PFI ( d = 0.48). CBI was associated with reduced illusions of control, whereas PFI was associated with reduced perceptions of gambling frequency norms. Reductions in perceived gambling frequency norms mediated effects of PFI on gambling frequency. Conclusions A single-session personalized feedback intervention and a multi-session cognitive-behavioral intervention may be helpful in reducing disordered gambling in US college students. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To determine whether collaborative behavioral management (CBM) reduces substance use, crime and re-arrest among drug-involved parolees. Design Step'n Out was a randomized behavioral trial of CBM versus standard parole (SP) during 2004-08. CBM adapted evidence-based role induction, behavioral contracting and contingent reinforcement to provide parole officer/treatment counselor dyads with positive tools in addition to sanctions to manage parolees' behavior over 12 weeks. Setting Six parole offices in five states in the USA. Participants Parolee volunteers with a mandate for addiction treatment and a minimum of 3 months of parole ( n = 476). Follow-up was 94% at 3 months and 86% at 9 months. Measurements Drug use and crime in a given month from calendar interviews 3 and 9 months after parole initiation, and re-arrests from criminal justice administrative data. Findings The CBM group had fewer months in which they used their primary drug [adjusted risk ratio (ARR) 0.20, 95% confidence interval (CI): 0.05, 0.78, P = 0.02] and alcohol (ARR 0.38, 95% CI: 0.22, 0.66, P = 0.006) over follow-up. CBM had its greatest effects among parolees who reported marijuana or another 'non-hard' drug as their primary drug; parolees who preferred stimulants or opiates did not benefit. No differences were seen in total crime, re-arrests or parole revocations. Conclusions Collaborative behavioral management may reduce substance use among primary marijuana or other 'non-hard' drug-using parolees without increasing revocations. Because the majority of drug violation arrests in the United States are for marijuana, these findings have important implications for the management of a substantial proportion of the US community correctional population. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims This study aimed to determine the relative effectiveness of 12 months of interim methadone (IM; supervised methadone with emergency counseling only for the first 4 months of treatment), standard methadone treatment (SM; with routine counseling) and restored methadone treatment (RM: routine counseling with smaller case-loads). Design A randomized controlled trial was conducted comparing IM, SM and RM treatment. IM lasted for 4 months, after which participants were transferred to SM. Setting The study was conducted in two methadone treatment programs in Baltimore, MD, USA. Participants The study included 230 adult methadone patients newly admitted through waiting-lists. Measurements We administered the Addiction Severity Index and a supplemental questionnaire at baseline, 4 and 12 months post- baseline. Measurements included retention in treatment, self-reported days of heroin and cocaine use, criminal behavior and arrests and urine tests for heroin and cocaine metabolites. Findings At 12 months, on an intent-to-treat basis, there were no significant differences in retention in treatment among the IM, SM and RM groups (60.6%, 54.8% and 37.0%, respectively). Positive urine tests for the three groups declined significantly from baseline ( Ps < 0.001 and 0.003, for heroin and cocaine metabolites, respectively) but there were no significant group x time interactions for these measures. At least one arrest was reported by 30.6% of the sample during the year, but there were no significant between-group effects. Conclusions Limited availability of drug counseling services should not be a barrier to providing supervised methadone to adults dependent on heroin-at least for the first 4 months of treatment. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Dual epidemics of human immunodeficiency virus (HIV) and alcohol use disorders, and a dearth of professional resources for behavioral treatment in sub-Saharan Africa, suggest the need for development of culturally relevant and feasible interventions. The purpose of this study was to test the preliminary efficacy of a culturally adapted six-session gender-stratified group cognitive-behavioral therapy (CBT) intervention delivered by paraprofessionals to reduce alcohol use among HIV-infected out-patients in Eldoret, Kenya. Design Randomized clinical trial comparing CBT against a usual care assessment-only control. Setting A large HIV out-patient clinic in Eldoret, Kenya, part of the Academic Model for Providing Access to Healthcare collaboration. Participants Seventy-five HIV-infected out-patients who were antiretroviral (ARV)-initiated or ARV-eligible and who reported hazardous or binge drinking. Measurements Percentage of drinking days (PDD) and mean drinks per drinking days (DDD) measured continuously using the Time line Follow back method. Findings There were 299 ineligible and 102 eligible out-patients with 12 refusals. Effect sizes of the change in alcohol use since baseline between the two conditions at the 30-day follow-up were large [ d = 0.95, P = 0.0002, mean difference = 24.93, 95% confidence interval (CI): 12.43, 37.43 PDD; d = 0.76, P = 0.002, mean difference = 2.88, 95% CI: 1.05, 4.70 DDD]. Randomized participants attended 93% of the six CBT sessions offered. Reported alcohol abstinence at the 90-day follow-up was 69% (CBT) and 38% (usual care). Paraprofessional counselors achieved independent ratings of adherence and competence equivalent to college-educated therapists in the United States. Treatment effect sizes were comparable to alcohol intervention studies conducted in the United States. Conclusions Cognitive-behavioral therapy can be adapted successfully to group paraprofessional delivery in Kenya and may be effective in reducing alcohol use among HIV-infected Kenyan out-patients. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims Smoking cessation trials generally record information on daily smoking behavior, but base analyses on measures of smoking status at the end of treatment (EOT). We present an alternative approach that analyzes the entire sequence of daily smoking status observations. Methods We analyzed daily abstinence data from a smoking cessation trial, using two longitudinal logistic regression methods: a mixed-effects (ME) model and a generalized estimating equations (GEE) model. We compared results to a standard analysis that takes abstinence status at EOT as outcome. We evaluated time-varying covariates (smoking history and time-varying drug effect) in the longitudinal analysis and compared ME and GEE approaches. Results We observed some differences in the estimated treatment effect odds ratios across models, with narrower confidence intervals under the longitudinal models. GEE yields similar results to ME when only baseline factors appear in the model, but gives biased results when one includes time-varying covariates. The longitudinal models indicate that the quit probability declines and the drug effect varies over time. Both the previous day's smoking status and recent smoking history predict quit probability, independently of the drug effect. Conclusion When analysing outcomes of studies from smoking cessation interventions, longitudinal models with multiple outcome data points, rather than just end of treatment, can makes efficient use of the data and incorporate time-varying covariates. The generalized estimating equations approach should be avoided when using time-varying predictors. [ABSTRACT FROM AUTHOR]

ABSTRACT Aims To determine whether 18 months of telephone continuing care improves 24-month outcomes for patients with alcohol dependence. Subgroup analyses were performed to identify patients who would benefit most from continuing care. Design Comparative effectiveness trial of continuing care that consisted of monitoring and feedback only (TM) or monitoring and feedback plus counseling (TMC). Patients were randomized to treatment as usual (TAU), TAU plus TM or TAU plus TMC, and followed quarterly for 24 months. Setting Publicly funded intensive out-patient programs (IOP). Participants A total of 252 alcohol-dependent patients (49% with current cocaine dependence) who completed 3 weeks of IOP. Measurements Percentage of days drinking, any heavy drinking and a composite good clinical outcome. Findings In the intent-to-treat sample, group differences in alcohol outcomes out to 18 months favoring TMC over TAU were no longer present in months 19-24. There was also a non-significant trend for TMC to perform better than usual care on the good clinical outcome measure (60% vs. 46% good clinical outcome in months 19-24). Overall significant effects favoring TMC and TM over TAU were seen for women; and TMC was also superior to TAU for participants with social support for drinking, low readiness to change and prior alcohol treatments. Most of these effects were obtained on at least two of three outcomes. However, no effects remained significant at 24 months. Conclusions The benefits of an extended telephone-based continuing care programme to treat alcohol dependence did not persist after the end of the intervention. A post-hoc analysis suggested that women and individuals with social support for drinking, low readiness to change or prior alcohol treatments may benefit from the intervention. [ABSTRACT FROM AUTHOR]

To determine the effect of offering smokers who want to quit easy access to nicotine replacement therapy (NRT), a period of familiarization and choice of product on smoking abstinence at 6 months. Single-blind, randomized controlled trial. New Zealand. A total of 1410 adult smokers who called the national Quitline for quitting support were randomized to usual Quitline care or a box containing different NRT products (patch, gum, inhaler, sublingual tablet, oral pouch) to try for a week prior to quitting, and then to choose one or two of these products for 8 weeks' use. The primary outcome was 7-day point prevalence smoking abstinence 6 months after quit day. Secondary outcomes included continuous abstinence, cigarette consumption, withdrawal, NRT choice and serious adverse events at 1 and 3 weeks and 3 and 6 months. No differences in 6-month quit rates (7-day point prevalence or continuous abstinence) were observed between the groups. However, smokers allocated to the intervention group were more likely to have quit smoking at 3 months [self-reported point prevalence, relative risk (RR) = 1.17, 95% confidence interval (CI): 1.02, 1.35, P = 0.03], had a longer time to relapse (median 70 days versus 28 days, P < 0.01) and used significantly more NRT. The selection box concept was highly acceptable to users, with the patch and inhaler combination the most popular choice (34%). In terms of smoking abstinence at 6 months, offering smokers who want to quit free access to a wide range of nicotine replacement therapy, including a 1-week period of familiarization and choice of up to two products, appears no different to offering reduced cost and choice of nicotine replacement therapy, with no familiarization period. [ABSTRACT FROM AUTHOR]