The End of My Addiction
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Low-Dose Baclofen and Craving Reduction
Full Article
Alcohol and Alcoholism vol. 37, no. 5, pp. 504–508, 2002
Baclofen efficacy in reducing alcohol craving and intake: a preliminary double-blind randomized controlled study
Giovanni Addolorato, Fabio Caputo, Esmeralda Capristo, Marco Domenicali, Mauro Bernardi, Luigi Janiri, Roberta Agabio, Giancarlo Colombo, Gian Luigi Gessa, and Giovanni Gasbarrini Institute of Internal Medicine and Institute of Psychiatry, Catholic University of Rome, Rome, ‘G. Fontana’ Centre for the Study and Treatment of the Alcohol Addiction, University of Bologna, Bologna, ‘Bernard B. Brodie’ Department of Neuroscience, University of Cagliari, C.N.R. Institute of Neurogenetics and Neuropharmacology, Cagliari and Neuroscienze S.c.a r.l., Cagliari, Italy
Abstract
Aims: The a-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.
Introduction
In recent years, the use of pharmacotherapy together with psychosocial interventions (including Alcoholics Anonymous and various counselling approaches) has enhanced the percentage of success in maintaining alcoholic patients in remission and assisting the development of a lifestyle compatible with long-term alcohol abstinence. However, to date, drugs with proven efficacy are very few (see Garbutt et al ., 1999; Swift, 1999; Kranzler, 2000) and the discovery of new medications capable of positively affecting the components of alcohol dependence syndrome, such as craving and loss of control on drinking or protracted abstinence symptoms, would represent an important step forward in the treatment of patients with alcohol problems (see Garbutt et al ., 1999).
Baclofen is a potent and stereoselective [.gamma]-aminobutyric acid (GABA B ) receptor agonist used clinically to control spasticity (Davidoff, 1985). Recent preclinical experiments have demonstrated the efficacy of baclofen in suppressing both alcohol withdrawal signs in rats made
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