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Background and aims: Alcohol use disorder (AUD) is a chronic disorder with high relapse rates. There are currently few clinical trials of high frequency repetitive transcranial magnetic stimulation (HF‐rTMS) to reduce alcohol use among AUD patients, and results are mixed. The current study tested the effect of 10 add‐on sessions of HF‐rTMS over the right dorsolateral pre‐frontal cortex (DLPFC) on alcohol use and craving. Design: Single‐center, single blind sham‐controlled parallel‐group RCT (n = 80), with 3 and 6 months follow‐up. Setting: Clinical treatment center in Amsterdam, the Netherlands. Participants: Eighty detoxified and abstinent AUD inpatients in clinical treatment (20 females, average age = 44.35 years). Intervention: Ten sessions of active or sham HF‐rTMS (60 10 Hz trains of 5 sec at 110% motor threshold) over the right DLPFC on 10 consecutive work‐days. Measurements The primary outcome measure is the number of abstinent days over 6‐month follow‐up (FU). Secondary outcome measures are craving over 6‐month FU (alcohol urge questionnaire and obsessive‐compulsive drinking scale), time to first relapse over 6‐month FU and grams of alcohol consumed over 6‐month FU. Additional outcome measures: full abstinence over 6‐month FU and treatment success over 12‐month FU. Findings HF‐rTMS did not affect the number of abstinent days over 6 months FU [sham = 124 ± 65.9 days, active = 115 ± 69.8 days, difference: 9 days, 95% confidence interval (CI) = Poisson model: 0.578–3.547]. Moreover, HF‐rTMS did not affect craving (AUQ/OCDS) (sham = 15.38/5.28, active = 17.48/4.75, differences = 2.1/−0.53, 95% CI mixed‐effects model = −9.14 to 2.07/−1.44 to 2.40). Conclusions: There was no clear evidence that high‐frequency repetitive transcranial magnetic stimulation over the right dorsolateral pre‐frontal cortex treatment has a long‐term positive effect on alcohol use or craving as add‐on treatment for alcohol use disorder. High treatment response at 6‐month follow‐up could have limited the possibility to find an effect. [ABSTRACT FROM AUTHOR]

Background and aims: Approach bias modification (ApBM) targeting alcohol approach bias has been previously shown to reduce likelihood of relapse during the first 2 weeks following inpatient withdrawal treatment (IWT). We tested whether ApBM's effects endure for a longer period by analysing alcohol use outcomes 3, 6 and 12 months post‐discharge. Design: A double‐blind, sham‐controlled randomized controlled trial. Setting: Four IWT units in Melbourne, Australia. Participants: Three hundred alcohol IWT patients (173 men, 126 women, 1 non‐binary; mean age 43.5 years) were recruited between 4 June 2017 and 14 July 2019. Follow‐up data collection was completed on 22 September 2020. Intervention and control training: Four ApBM sessions were delivered during IWT. ApBM trained participants (n = 147) to avoid alcohol and approach non‐alcohol beverage cues. Controls (n = 153) responded to the same stimuli, but without approach/avoidance training. Measurements Date of first lapse was recorded for non‐abstinent participants to determine time to first lapse. Time‐line follow‐back interviews assessed past‐month alcohol consumption at each follow‐up, with participants reporting no alcohol consumption classified as abstinent. In analyses of past‐month abstinence, non‐abstinence was assumed in participants lost to follow‐up. Number of past‐month drinking days, standard drinks and heavy drinking days (five or more standard drinks for women or non‐binary; six or more standard drinks for men) were calculated for non‐abstinent participants at each follow‐up. Findings ApBM significantly delayed time to first lapse [ApBM median: 53 days, 95% confidence interval (CI) = 21–61; controls = 12 days, 95% CI = 9–21, P = 0.045]. Past‐month abstinence rates at 3‐, 6‐ and 12‐month follow‐ups were 33/153 (21.6%), 30/153 (19.6%), and 24/153 (15.7%) in controls; and 51/147 (34.7%), 30/147 (20.4%) and 29/147 (19.7%) in the ApBM group, respectively. Past‐month abstinence was significantly more likely in ApBM participants than controls at the 3‐month follow‐up [odds ratio (OR) = 1.93, 95% CI = 1.16–3.23, P = 0.012], but not at 6‐ or 12‐month follow‐ups (6‐month OR = 1.05, 95% CI = 0.60–1.95, P = 0.862; 12‐month OR = 1.32, 95% CI = 0.73–2.40, P = 0.360). No significant group differences were found for indices of alcohol consumption in non‐abstinent participants. Conclusions: Approach bias modification for alcohol delivered during inpatient withdrawal treatment helps to prevent relapse, increasing rates of abstinence from alcohol for at least 3 months post‐discharge. [ABSTRACT FROM AUTHOR]

Aim: To determine whether cytisine was at least as effective as varenicline in supporting smoking abstinence for ≥ 6 months in New Zealand indigenous Māori or whānau (extended‐family) of Māori, given the high smoking prevalence in this population. Design Pragmatic, open‐label, randomized, community‐based non‐inferiority trial. Setting: Bay of Plenty, Tokoroa and Lakes District Health Board regions of New Zealand. Participants: Adult daily smokers who identified as Māori or whānau of Māori, were motivated to quit in the next 2 weeks, were aged ≥ 18 years and were eligible for subsidized varenicline. Recruitment used multi‐media advertising. Interventions: A total of 679 people were randomly assigned (1 : 1) to receive a prescription for 12 weeks of cytisine or varenicline, plus low‐intensity cessation behavioural support from the prescribing doctor and community stop‐smoking services or a research assistant. Day 5 of treatment was the designated quit date. Measurements The primary outcome was carbon monoxide‐verified continuous abstinence at 6 months, analysed as intention‐to‐treat (with multiple imputation for missing data). Secondary outcomes measured at 1, 3, 6 and 12 months post‐quit date included: self‐reported continuous abstinence, 7‐day point prevalence abstinence, cigarettes per day, time to (re)lapse, adverse events, treatment adherence/compliance and acceptability, nicotine withdrawal/urge to smoke and health‐care utilization/health‐related quality of life. Findings Verified continuous abstinence rates at 6 months post‐quit date were 12.1% (41 of 337) for cytisine versus 7.9% (27 of 342) for varenicline [risk difference 4.29%, 95% confidence interval (CI) = –0.22 to 8.79; relative risk 1.55; 95% CI = 0.97–2.46]. Sensitivity analyses confirmed that the findings were robust. Self‐reported adverse events over 6 months occurred significantly more frequently in the varenicline group (cytisine: 313 events in 111 participants; varenicline: 509 events in 138 participants, incidence rate ratio 0.56, 95% CI = 0.49–0.65, P < 0.001) compared with the cytisine group. Common adverse events were headache, nausea and difficulty sleeping. Conclusion: A randomized controlled trial found that cytisine was at least as effective as varenicline at supporting smoking abstinence in New Zealand indigenous Māori or whānau (extended‐family) of Māori, with significantly fewer adverse events. [ABSTRACT FROM AUTHOR]

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

Background and aim: To address the widespread severe problems with opioid use disorder, buprenorphine–naloxone treatment provided by primary care physicians has greatly expanded treatment access; however, treatment is often provided with minimal or no behavioral interventions. Whether or which behavioral interventions are feasible to implement in various settings and improve treatment outcomes has not been established. This study aimed to evaluate two behavioral interventions to improve buprenorphine–naloxone treatment. Design A 2 × 2 factorial, repeated‐measures, open‐label, randomized clinical trial. Settings General medical practice offices in Muar, Malaysia. Participants: Opioid‐dependent individuals (n = 234). Interventions: Participants were randomly assigned to one of four treatment conditions and received study interventions for 24 weeks: (1) physician management with or without behavioral counseling and (2) physician management with or without abstinence‐contingent buprenorphine–naloxone (ACB) take‐home doses. Measurements The primary outcomes were proportions of opioid‐negative urine tests and HIV risk behaviors [assessed by audio computer‐assisted AIDS risk inventory (ACASI‐ARI)]. Findings The rates of opioid‐negative urine tests over 24 weeks of treatment were significantly higher with [68.2%, 95% confidence interval (CI) = 65–71] than without behavioral counseling (59.2%, 95% CI = 56–62, P < 0.001) and with (71.0%, 95% CI = 68–74) than without ACB (56.4%, 95% CI = 53–59, P < 0.001); interaction effects between and among behavioral interventions and time were not statistically significant. Scores on ACASI‐ARI decreased significantly from baseline across all treatment groups (P < 0.001) and did not differ significantly with or without behavioral counseling (P = 0.099) or with or without ACB (P = 0.339). Conclusions: Providing opioid‐dependent patients in Muar, Malaysia with buprenorphine–naloxone and physician management plus behavioral counseling or abstinence‐contingent buprenorphine–naloxone (ACB) resulted in greater reductions of opioid use compared with providing buprenorphine–naloxone and physician management without behavioral counseling or ACB. [ABSTRACT FROM AUTHOR]

Aims: To assess the effectiveness of training stop smoking services providers in Malaysia to deliver support for smoking cessation based on the UK National Centre for Smoking Cessation and Training (NCSCT) standard treatment programme compared with usual care. Design Two‐arm cluster‐randomized controlled effectiveness trial across 19 sites with follow‐up at 4‐week, 3‐month, and 6‐month. Setting: Stop smoking services operating in public hospitals in Malaysia. Participants: Five hundred and two smokers [mean ± standard deviation (SD), age 45.6 (13.4) years; 97.4% male] attending stop smoking services in hospital settings in Malaysia: 330 in 10 hospitals in the intervention condition and 172 in nine hospitals in the control condition. Intervention and comparator: The intervention consisted of training stop‐smoking practitioners to deliver support and follow‐up according to the NCSCT Standard Treatment Programme. The comparator was usual care (brief support and follow‐up). Measurements: The primary outcome was continuous tobacco smoking abstinence up to 6 months in smokers who received smoking cessation treatment, verified by expired‐air carbon monoxide (CO) concentration. Secondary outcomes were continuous CO‐verified tobacco smoking abstinence up to 4 weeks and 3 months. Results: Follow‐up rates at 4 weeks, 3 months and 6 months were 80.0, 70.6 and 53.3%, respectively, in the intervention group and 48.8, 30.8 and 23.3%, respectively, in the control group. At 6‐month follow‐up, 93 participants in the intervention group and 19 participants in the control group were abstinent from smoking, representing 28.2 versus 11.0% in an intention‐to‐treat (ITT) analysis assuming that participants with missing data had resumed smoking, and 52.8 versus 47.5% in a follow‐up‐only (FUO) analysis. Unadjusted odds ratios (accounting for clustering) were 5.04, (95% confidence interval (CI) = 1.22–20.77, P = 0.025) and 1.70, (95% CI = 0.25–11.53, P = 0.589) in the ITT and FUO analyses, respectively. Abstinence rates at 4 week and 3 month follow‐ups were significantly higher in the intervention versus control group in the ITT but not the FUO analysis. Conclusions: On an intention‐to‐treat analysis with missing‐equals‐smoking imputation, training Malaysian stop smoking service providers in the UK National Centre for Smoking Cessation and Training standard treatment programme appeared to increase 6 month continuous abstinence rates in smokers seeking help with stopping compared with usual care. However, the effect may have been due to increasing follow‐up rates. [ABSTRACT FROM AUTHOR]