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A Double-Blind, Placebo-Controlled Trial Assessing the Efficacy of Varenicline Tartrate for Alcohol Dependence
Open accessAbstract
OBJECTIVES: To assess the efficacy and safety of varenicline (Chantix) for the treatment of alcohol dependence. Varenicline is a partial α4β2 nicotinic acetylcholine agonist approved by the Food and Drug Administration for smoking cessation. It has reduced drinking in animal studies and in small studies of humans who were both heavy drinkers and smokers. This is the first multisite clinical trial of varenicline in a population of smokers and nonsmokers with alcohol dependence. METHODS: Men and women (n = 200) meeting the criteria for alcohol dependence were recruited across 5 clinical sites. Patients received double-blind varenicline or placebo and a computerized behavioral intervention. Varenicline was titrated during the first week to 2 mg/d, which was maintained during weeks 2 to 13. RESULTS: The varenicline group had significantly lower weekly percent heavy drinking days (primary outcome) (adjusted mean difference = 10.4), drinks per day, drinks per drinking day, and alcohol craving compared with the placebo group (P < 0.05). The average treatment effect on alcohol use was similar for smokers and nonsmokers. Varenicline was well-tolerated; adverse events were expected and mild. CONCLUSIONS: Varenicline significantly reduced alcohol consumption and craving, making it a potentially viable option for the treatment of alcohol dependence.
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“There was no evidence of association between nicotinic receptor genes or pathways with DrnkWk, despite the use of nicotinic receptor partial agonists (e.g., varenicline) in the treatment of alcohol dependence33.”
From Association studies of up to 1.2 million individuals yield new insights into the genetic etiology of tobacco and alcohol use (2019) · cites this paper as [33]
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Metadata
- Authors
- Litten, R. Z., Ryan, M. L., Fertig, J. B., Falk, D. E., Johnson, B., Dunn, K. E., Green, A. I., Pettinati, H. M., Ciraulo, D. A., Sarid-Segal, O., Kampman, K., Brunette, M. F., Strain, E. C., Tiouririne, N. A., Ransom, J., Scott, C., & Stout, R.
- Affiliations
- Boston University (US)
- National Institutes of Health (US)
- University of Virginia (US)
- Dartmouth College (US)
- University of Pennsylvania (US)
- Johns Hopkins University (US)
- Fast Track Drugs and Biologics (US)
- Pacific Institute For Research and Evaluation (US)
- Corresponding author
- Litten, Raye Z.
- ORCID
- Venue
- Journal of Addiction Medicine
- Published
- 2013-07
- Volume
- 7
- Issue
- 4
- Pages
- 277-286
- ISSN
- 1932-0620 (ISSN-L)
- PMC
- PMC3914416
- OpenAlex
- W2006833508
- Cited by
- 287
- References
- 47
- Citations by year
- 2026: 7 · 2025: 15 · 2024: 10 · 2023: 25 · 2022: 9 · 2021: 40 · 2020: 21 · 2019: 24 · 2018: 25 · 2017: 26 · 2016: 26 · 2015: 25 · 2014: 26 · 2013: 7
- FWCI
- 20.40
- Type
- journal article
- Language
- en
- Open access
- green
- www.ncbi.nlm.nih.gov
- Locations
- Journal of Addiction Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- National Institutes of Health (4k24da023186-10)
- U.S. Public Health Service (HHSN27200900005C)
- National Institute on Alcohol Abuse and Alcoholism
- National Institute on Drug Abuse (K24-DA023186)
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (HHSN275200900005C)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Smoking Behavior and Cessation
- Keywords
- varenicline, alcoholism, nicotinic agonists, alcohol craving, heavy drinking, smoking cessation, drug efficacy, drug safety
- MeSH terms
- Varenicline, Adult, Alcoholism, Benzazepines, Double-Blind Method, Female, Humans, Male, Middle Aged, Quinoxalines, Treatment Outcome, Medication Adherence
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