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Original Investigation |

Gabapentin Treatment for Alcohol Dependence:  A Randomized Clinical Trial

Barbara J. Mason, PhD1; Susan Quello, BA, BS1; Vivian Goodell, MPH1; Farhad Shadan, MD2; Mark Kyle, MD2; Adnan Begovic, MD2
[+] Author Affiliations
1The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California
2Scripps Clinic and Scripps Green Hospital, La Jolla, California
JAMA Intern Med. 2014;174(1):70-77. doi:10.1001/jamainternmed.2013.11950.
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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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Figures

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Figure 1.
Flow of Participants Through the Trial

PI indicates principal investigator.

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Figure 2.
Gabapentin Effects on Rates of No Heavy Drinking and Complete Abstinence During the 12-Week Study in the Intention-to-Treat Population

A, No heavy drinking; B, complete abstinence. Error bars indicate 95% confidence intervals (N = 150).

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Figure 3.
Gabapentin Effects on Number of Drinks per Week and Number of Heavy Drinking Days per Week During the 12-Week Study in the Intention-to-Treat Population

A, Number of drinks per week; B, number of heavy drinking days per week. Error bars indicate SEM (N = 150).

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Figure 4.
Gabapentin Effects on Standardized Measures of Craving, Sleep, and Mood During the 12-Week Study in the Intention-to-Treat Population

A, Alcohol Craving Questionnaire; B, Pittsburgh Sleep Quality Index; C, Beck Depression Inventory II. Error bars indicate SEM (N = 150).

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