Efficacy and tolerability of baclofen in a U.S. community population with alcohol use disorder: A dose-response, randomized, controlled trial
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agonist, has been identified as a potential pharmacotherapy for AUD. In a 16-week double-blind, randomized, placebo-controlled trial, we investigated 30 and 90 mg/day of baclofen compared to placebo and examined effects of dose, sex, and level of pretreatment drinking. One hundred and twenty participants with DSM-IV alcohol dependence (age 46.1 (sd = 10.1) years, 51.7% male) were randomized after exclusion for unstable medical/psychiatric illness and/or dependence on drugs other than nicotine. Seventy-three participants completed the trial. A main effect of baclofen was found [%HDD (F(2,112) = 4.16, p = 0.018, d = 0.51 95%CI (0.06-0.95), 13.6 fewer HDD) and %ABST (F(2,112) = 3.68, p = 0.028, d = 0.49 95%CI (0.04-0.93), 12.9 more abstinent days)] and was driven by the 90 mg/day dose. A sex × dose interaction effect was present for both %HDD (F(2,110) = 5.48, p = 0.005) and %ABST (F(2,110) = 3.19, p = 0.045). Men showed a marginally positive effect for 90 mg/day compared to PBO (%HDD t(110) = 1.88, p = 0.063, d = 0.36 95%CI (-0.09-0.80), 15.8 fewer HDD days; %ABST t(110) = 1.68 (p = 0.096, d = 0.32 95%CI (-0.12-0.76), 15.7 more ABST)) with no effect for 30 mg/day. Women showed a positive effect for 30 mg/day (%HDD, t(110) = 3.19, p = 0.002, d = 0.61 95%CI (0.16-1.05), 26.3 fewer HDD days; %ABST t(110) = 2.73, p = 0.007, d = 0.52 95%CI (0.07-0.96), 25.4 more ABST days) with marginal effects for 90 mg/day on %ABST (p = 0.06) with drop-outs/dose reduction from sedative side-effects of 59% in women at 90 mg/day compared to 5% for men. These findings support the hypothesis that baclofen has efficacy in AUD and suggest that dose and sex be further explored as potential moderators of baclofen response and tolerability.
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In a 16-week RCT with 120 participants diagnosed with AUD, baclofen at 90 mg/day led to a reduction in the percentage of heavy drinking days and an increase in abstinent days, and higher doses were less well tolerated in female participants.
“The key findings indicated a significant impact of baclofen, particularly at the 90 mg/day dose, leading to a reduction in the percentage of heavy drinking days and an increase in abstinent days. Notably, higher doses were less well tolerated in female participants [56].”
From A Narrative Review of Current and Emerging Trends in the Treatment of Alcohol Use Disorder (2024) · cites this paper as [56]
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- Authors
- Garbutt, J. C., Kampov-Polevoy, A. B., Pedersen, C., Stansbury, M., Jordan, R., Willing, L., & Gallop, R. J.
- Affiliations
- University of North Carolina at Chapel Hill (US)
- West Chester University (US)
- Corresponding author
- Garbutt, James C.
- Venue
- Neuropsychopharmacology
- Published
- 2021-06-21
- Volume
- 46
- Issue
- 13
- Pages
- 2250-2256
- ISSN
- 0893-133X (ISSN-L)
- 1740-634X
- PMC
- PMC8580979
- OpenAlex
- W3176085562
- Cited by
- 68
- References
- 38
- Citations by year
- 2026: 6 · 2025: 11 · 2024: 17 · 2023: 12 · 2022: 21 · 2021: 1
- FWCI
- 9.18
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Locations
- Neuropsychopharmacology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Funders
- University of South Carolina
- National Institute on Alcohol Abuse and Alcoholism (R01AA020824)
- Topics
- Health Sciences › Medicine › Epidemiology › Substance Abuse Treatment and Outcomes
- Health Sciences › Medicine › Pathology and Forensic Medicine › Alcohol Consumption and Health Effects
- Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Neurotransmitter Receptor Influence on Behavior
- Keywords
- baclofen, alcoholism, dose-response relationship, sex differences, alcohol abstinence, heavy drinking days, alcohol withdrawal symptoms, tolerability, community-dwelling adults, alcohol dependence severity, relapse prevention
- MeSH terms
- Alcoholism, Baclofen, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome
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