Baclofen Efficacy in Reducing Alcohol Craving and Intake: A Preliminary Double-Blind Randomized Controlled Study

Authors: G. Gasbarrini¹; G. Addolorato¹; F. Caputo²; E. Capristo¹; M. Domenicali²; M. Bernardi²; L. Janiri³; R. Agabio⁴; G. Colombo⁵; G.L. Gessa⁴

Source: Alcohol and Alcoholism, Volume 37, Number 5, 1 September 2002 , pp. 504-508(5)

Publisher: Oxford University Press

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Abstract:

— Aims: The gamma

-aminobutyric acid (GABA_B) receptor agonist, baclofen, has recently been shown to reduce alcohol intake in alcohol-preferring rats and alcohol consumption and craving for alcohol in an open study in humans. The present study was aimed at providing a first evaluation of the efficacy of baclofen in inducing and maintaining abstinence and reducing craving for alcohol in alcohol-dependent patients in a double-blind placebo-controlled design. Methods: A total of 39 alcohol-dependent patients were consecutively enrolled in the study. After 12–24 h of abstinence from alcohol, patients were randomly divided into two groups. Twenty patients were treated with baclofen and 19 with placebo. Drug and placebo were orally administered for 30 consecutive days. Baclofen was administered at the dose of 15 mg/day for the first 3 days and 30 mg/day for the subsequent 27 days, divided into three daily doses. Patients were monitored as out-patients on a weekly basis. At each visit alcohol intake, abstinence from alcohol, alcohol craving and changes in affective disorders were evaluated. Results: A higher percentage of subjects totally abstinent from alcohol and a higher number of cumulative abstinence days throughout the study period were found in the baclofen, compared to the placebo, group. A decrease in the obsessive and compulsive components of craving was found in the baclofen compared to the placebo group; likewise, alcohol intake was reduced in the baclofen group. A decrease in state anxiety was found in the baclofen compared to the placebo group. No significant difference was found between the two groups in terms of current depressive symptoms. Baclofen proved to be easily manageable and no patient discontinued treatment due to the presence of side-effects. No patient was affected by craving for the drug and/or drug abuse. Conclusions: Baclofen proved to be effective in inducing abstinence from alcohol and reducing alcohol craving and consumption in alcoholics. With the limits posed by the small number of subjects involved, the results of this preliminary double-blind study suggest that baclofen may represent a potentially useful drug in the treatment of alcohol-dependent patients and thus merits further investigations.

Document Type: Original article

Affiliations: 1: Institute of Internal Medicine and 2: ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna, 3: Institute of Psychiatry, Catholic University of Rome, Rome, 4: ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari, 5: C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and

Publication date: 2002-09-01

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Alcohol and Alcoholism publishes papers on biomedical, psychological and sociological aspects of alcoholism and alcohol research, provided that they make a new and significant contribution to knowledge in the field. Papers include new results obtained experimentally, descriptions of new experimental (including clinical) methods of importance to the field of alcohol research and treatment, or new interpretations of existing results. Theoretical contributions are considered equally with papers dealing with experimental work provided that such theoretical contribution are not of a largely speculative or philosophical nature. Alcohol and Alcoholism is the official journal of the Medical Council on Alcohol.

Baclofen Efficacy in Reducing Alcohol Craving and Intake: A Preliminary Double-Blind Randomized Controlled Study

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