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Gabapentin treatment for alcohol dependence: a randomized clinical trial.
JAMA Intern Med. 2014 Jan; 174(1):70-7.JIM

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.

Authors+Show Affiliations

The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California.The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California.The Scripps Research Institute, Pearson Center for Alcoholism and Addiction Research, La Jolla, California.Scripps Clinic and Scripps Green Hospital, La Jolla, California.Scripps Clinic and Scripps Green Hospital, La Jolla, California.Scripps Clinic and Scripps Green Hospital, La Jolla, California.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

24190578

Citation

Mason, Barbara J., et al. "Gabapentin Treatment for Alcohol Dependence: a Randomized Clinical Trial." JAMA Internal Medicine, vol. 174, no. 1, 2014, pp. 70-7.
Mason BJ, Quello S, Goodell V, et al. Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Intern Med. 2014;174(1):70-7.
Mason, B. J., Quello, S., Goodell, V., Shadan, F., Kyle, M., & Begovic, A. (2014). Gabapentin treatment for alcohol dependence: a randomized clinical trial. JAMA Internal Medicine, 174(1), 70-7. https://doi.org/10.1001/jamainternmed.2013.11950
Mason BJ, et al. Gabapentin Treatment for Alcohol Dependence: a Randomized Clinical Trial. JAMA Intern Med. 2014;174(1):70-7. PubMed PMID: 24190578.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Gabapentin treatment for alcohol dependence: a randomized clinical trial. AU - Mason,Barbara J, AU - Quello,Susan, AU - Goodell,Vivian, AU - Shadan,Farhad, AU - Kyle,Mark, AU - Begovic,Adnan, PY - 2013/11/6/entrez PY - 2013/11/6/pubmed PY - 2014/3/13/medline SP - 70 EP - 7 JF - JAMA internal medicine JO - JAMA Intern Med VL - 174 IS - 1 N2 - 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. SN - 2168-6114 UR - https://www.unboundmedicine.com/medline/citation/24190578/Gabapentin_treatment_for_alcohol_dependence:_a_randomized_clinical_trial_ L2 - https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/10.1001/jamainternmed.2013.11950 DB - PRIME DP - Unbound Medicine ER -