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Cited by 340Substance Abuse Treatment and OutcomesAlcohol Consumption and Health EffectsOpioid Use Disorder Treatment

Gabapentin Treatment for Alcohol Dependence: A Randomized Clinical Trial

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Mason, Barbara J., Quello, Susan, Goodell, Vivian, Shadan, Farhad, Kyle, Mark, Begovic, Adnan·2014·JAMA Internal Medicine
DOI 10.1001/jamainternmed.2013.11950PMC PMC3920987
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Abstract

IMPORTANCE: Approved medications for alcohol dependence are prescribed for less than 9% of US alcoholics. OBJECTIVE: To determine if gabapentin, a widely prescribed generic calcium channel/γ-aminobutyric acid-modulating medication, increases rates of sustained abstinence and no heavy drinking and decreases alcohol-related insomnia, dysphoria, and craving, in a dose-dependent manner. DESIGN, PARTICIPANTS AND SETTING: A 12-week, double-blind, placebo-controlled, randomized dose-ranging trial of 150 men and women older than 18 years with current alcohol dependence, conducted from 2004 through 2010 at a single-site, outpatient clinical research facility adjoining a general medical hospital. INTERVENTIONS: Oral gabapentin (dosages of 0 [placebo], 900 mg, or 1800 mg/d) and concomitant manual-guided counseling. MAIN OUTCOMES AND MEASURES: Rates of complete abstinence and no heavy drinking (coprimary) and changes in mood, sleep, and craving (secondary) over the 12-week study. RESULTS Gabapentin significantly improved the rates of abstinence and no heavy drinking. The abstinence rate was 4.1% (95% CI, 1.1%-13.7%) in the placebo group, 11.1% (95% CI, 5.2%-22.2%) in the 900-mg group, and 17.0% (95% CI, 8.9%-30.1%) in the 1800-mg group (P = .04 for linear dose effect; number needed to treat [NNT] = 8 for 1800 mg). The no heavy drinking rate was 22.5% (95% CI, 13.6%-37.2%) in the placebo group, 29.6% (95% CI, 19.1%-42.8%) in the 900-mg group, and 44.7% (95% CI, 31.4%-58.8%) in the 1800-mg group (P = .02 for linear dose effect; NNT = 5 for 1800 mg). Similar linear dose effects were obtained with measures of mood (F2 = 7.37; P = .001), sleep (F2 = 136; P < .001), and craving (F2 = 3.56; P = .03). There were no serious drug-related adverse events, and terminations owing to adverse events (9 of 150 participants), time in the study (mean [SD], 9.1 [3.8] weeks), and rate of study completion (85 of 150 participants) did not differ among groups. CONCLUSIONS AND RELEVANCE: Gabapentin (particularly the 1800-mg dosage) was effective in treating alcohol dependence and relapse-related symptoms of insomnia, dysphoria, and craving, with a favorable safety profile. Increased implementation of pharmacological treatment of alcohol dependence in primary care may be a major benefit of gabapentin as a treatment option for alcohol dependence. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00391716.

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  • Gabapentin reversed sleep disturbances in AUD.

    “Notably, gabapentin reversed sleep disturbances in AUD (Mason et al., 2014).”

    From Drug Addiction: Hyperkatifeia/Negative Reinforcement as a Framework for Medications Development (2021) · cites this paper as Mason et al., 2014

    The Discussion reports that participants’ pretreatment sleep disturbances significantly improved with gabapentin relative to placebo, and the Results report a dose-dependent improvement in sleep quality. Neither passage establishes that the disturbances were fully reversed; the claim is stronger than the reported finding. (LLM, conf=0.85)

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  • Gabapentin blocked craving in non-treatment-seeking AUD subjects and was effective treatment of AUD in a double-blind placebo-controlled clinical trial.

    “In human studies, gabapentin blocked craving in a human laboratory study in non-treatment-seeking AUD subjects (Mason et al., 2009) and was shown to be an effective treatment of AUD in a double-blind placebo-controlled clinical trial (Mason et al., 2014).”

    From Drug Addiction: Hyperkatifeia/Negative Reinforcement as a Framework for Medications Development (2021) · cites this paper as Mason et al., 2014

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Research works printed but not linked: 3

  1. [23]First Michael B. Spitzer Robert L Gibbon Miriam Williams Janet B.W. Structured Clinical Interview for DSM-IV-TR Axis I Disorders, Research Version, Patient Edition. (SCID-I/P) 11 2002 Biometrics Research, New York State Psychiatric Institute New York
  2. [33]FDA Medical Review of Vivitrol: 21-897 2006 U.S. Government Rockville, MD
  3. [40]Norusis MJ SPSS Statistics 17.0 Advanced Statistical Procedures Companion 2008 Prentice Hall Inc. Upper Saddle River, NJ

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Authors
Mason, B. J., Quello, S., Goodell, V., Shadan, F., Kyle, M., & Begovic, A.
Affiliations
  • Scripps Research Institute (US)
  • The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California
Corresponding author
Mason, Barbara J.
Venue
JAMA Internal Medicine
Publisher
American Medical Association (AMA)
Published
2014-01-01
Volume
174
Issue
1
Pages
70
ISSN
2168-6106 (ISSN-L)
DOI
10.1001/jamainternmed.2013.11950
PMC
PMC3920987
OpenAlex
W2159492208
Cited by
340
References
41
Citations by year
2026: 14 · 2025: 16 · 2024: 23 · 2023: 24 · 2022: 25 · 2021: 28 · 2020: 30 · 2019: 41 · 2018: 32 · 2017: 24 · 2016: 27 · 2015: 34 · 2014: 20 · 2013: 2
FWCI
20.20
Type
journal article
Language
en
Open access
Locations
  • JAMA Internal Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute on Alcohol Abuse and Alcoholism (R37AA014028, R01AA014028)
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 › Opioid Use Disorder Treatment
Keywords
gabapentin, alcoholism, sustained abstinence, heavy drinking, alcohol craving, dysphoria, mood, dose-response relationship, calcium channel modulators, number needed to treat, medication adherence, relapse prevention
MeSH terms
Gabapentin, Adult, Ethanol, Alcoholism, Amines, Central Nervous System Depressants, Cyclohexanecarboxylic Acids, Double-Blind Method, Female, gamma-Aminobutyric Acid, Humans, Male, Middle Aged, Substance Withdrawal Syndrome, Treatment Outcome, GABA Modulators, Alcohol Abstinence

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