Trial reportThe American journal of psychiatry2021
Efficacy of Combining Varenicline and Naltrexone for Smoking Cessation and Drinking Reduction: A Randomized Clinical Trial.
Trial report in The American journal of psychiatry, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
17 citing papers in PubMed, 1 synthesis or guideline pooled it, 36 citations in OpenAlex.
- Evidence-based consensus guidelines for the pharmacological management of substance dependence: Recommendations from the British Association for Psychopharmacology.Journal of psychopharmacology (Oxford, England) · 2026Guideline
- High- and low-dose topiramate for the treatment of persons with alcohol use disorder who smoke cigarettes: A randomized control trial.Alcohol, clinical & experimental research · 2025Trial
- Ibudilast attenuates the association between pain intensity and heavy drinking in alcohol use disorder: A secondary analysis of a randomized clinical trial.Alcohol (Fayetteville, N.Y.) · 2025Trial
- The Effects of Menstrual Cycle Hormones on Responses to Varenicline and Naltrexone Among Female Heavy Drinking Smokers.Alcohol and alcoholism (Oxford, Oxfordshire) · 2022Trial
- Effect of Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Among Smokers Who Drink Heavily: A Randomized Clinical Trial.JAMA network open · 2022Trial
- Combination Treatment With Varenicline and Nicotine Patch on Smoking Cessation Outcomes in Heavy Drinkers at 26-Week Follow-up.Journal of clinical psychopharmacologyTrial
- Missing Data Sensitivity Analyses for Alcohol Research.Alcohol, clinical & experimental research · 2026Article
- Reductions in World Health Organization Risk Drinking Levels as a Primary Efficacy End Point for Alcohol Clinical Trials: A Review.JAMA psychiatry · 2025Review
- Effects of alcohol and cannabis co-use on salience network resting state functional connectivity in individuals who drink alcohol heavily.Drug and alcohol dependence · 2025Article
- The combination of a glucagon-like peptide-1 and amylin receptor agonists reduces alcohol consumption in both male and female rats.Acta neuropsychiatrica · 2024Article
- Enhancing translation: A need to leverage complex preclinical models of addictive drugs to accelerate substance use treatment options.Pharmacology, biochemistry, and behavior · 2024Review
- Trends in cigarette use and health insurance coverage among US adults with mental health and substance use disorders.Addiction (Abingdon, England) · 2023Article
- Review
- TOBACCO USE DISORDER AND DUAL DISORDERS Joint statement by the Spanish Psychiatry Society and the Spanish Dual Disorders Society.Actas espanolas de psiquiatria · 2022Article
- Characteristics associated with treatment seeking for smoking cessation among heavy-drinking research participants.Frontiers in psychiatry · 2022Article
- Combined varenicline and naltrexone attenuates alcohol cue-elicited activation in heavy drinking smokers.Drug and alcohol dependence · 2021Article
- Pharmacological interventions for alcohol use disorder: novel insights from recent clinical trials.Expert review of clinical pharmacologyReview
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Authors and funding
14 authors at 2 institutions in 1 country.
Funding
Abstract
objectivePharmacological treatments that can concomitantly address cigarette smoking and heavy drinking stand to improve health care delivery for these highly prevalent co-occurring conditions. This superiority trial compared the combination of varenicline and naltrexone against varenicline alone for smoking cessation and drinking reduction among heavy-drinking smokers.
methodsThis was a phase 2 randomized double-blind clinical trial. Participants (N=165) who were daily smokers and drank heavily received either 2 mg/day of varenicline plus 50 mg/day of naltrexone or 2 mg/day of varenicline plus matched placebo pills for 12 weeks. Primary outcomes were 7-day point prevalence of nicotine abstinence (bioverified by a breath CO reading ≤5 ppm) at the 26-week follow-up and number of drinks per drinking day during the 12-week treatment phase.
resultsSmoking abstinence at week 26 was significantly higher in the varenicline plus placebo condition than in the varenicline plus naltrexone condition (N=37 [45.1%] compared with N=22 [26.5%]). For drinks per drinking day, there was a medication effect favoring the combination of varenicline and naltrexone over varenicline alone across the 12-week treatment phase, although it did not meet the significance threshold.
conclusionsThese findings suggest that smoking cessation and drinking reduction can be concomitantly targeted with pharmacotherapy and that while varenicline alone may be sufficient as a smoking cessation aid in heavy-drinking smokers, the combination of varenicline and naltrexone may confer benefits with regard to drinking outcomes, particularly during the 12-week period of active medication treatment.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.