BACKGROUND: Recent preclinical and clinical studies have shown that the gamma-aminobutyric acid-B agonist baclofen may be an effective treatment for reducing alcohol consumption. This preliminary open-label investigation examined the tolerability and effect of a 30-mg daily baclofen dose for reducing drinking, subclinical anxiety and depressive symptoms, and cravingin alcohol-dependent subjects. METHODS:Nine men and three women participated in a 12-week trial during which they took baclofen on a 10 mg thrice-daily regimen and received four sessions of motivational enhancement therapy. Each participant received a comprehensive physical and psychiatric screening before being enrolled. At each visit, side effects were monitored with a revised version of the Systematic Assessment of Treatment Emergent Events-General Inquiry, and drinking data were collected via the timeline follow-back interview. Participants also completed the Beck Depression Inventory, the Beck Anxiety Inventory, and the Penn Alcohol Craving Scale at each visit. RESULTS:Baclofen was reasonably tolerated. Two participants discontinued because of side effects. No serious adverse events were noted. Six other individuals did not complete the trial. Overall, there were statistically significant reductions in the number of drinks per drinking day and the number of heavy-drinking days, and there was an increase in the number of abstinent days. Significant decreases in anxiety and craving were also shown. CONCLUSIONS: These findings suggest that baclofen is reasonably tolerated in an alcohol-dependent population, although the high dropout rate in the study is of concern. Baclofen may be effective for the reduction of drinking, anxiety, and craving for some alcohol-dependent individuals. A larger-scale placebo-controlled study is needed to further explore these effects and to determine the characteristics of those who respond to this medication.
RCT Entities:
BACKGROUND: Recent preclinical and clinical studies have shown that the gamma-aminobutyric acid-B agonist baclofen may be an effective treatment for reducing alcohol consumption. This preliminary open-label investigation examined the tolerability and effect of a 30-mg daily baclofen dose for reducing drinking, subclinical anxiety and depressive symptoms, and craving in alcohol-dependent subjects. METHODS: Nine men and three women participated in a 12-week trial during which they took baclofen on a 10 mg thrice-daily regimen and received four sessions of motivational enhancement therapy. Each participant received a comprehensive physical and psychiatric screening before being enrolled. At each visit, side effects were monitored with a revised version of the Systematic Assessment of Treatment Emergent Events-General Inquiry, and drinking data were collected via the timeline follow-back interview. Participants also completed the Beck Depression Inventory, the Beck Anxiety Inventory, and the Penn Alcohol Craving Scale at each visit. RESULTS:Baclofen was reasonably tolerated. Two participants discontinued because of side effects. No serious adverse events were noted. Six other individuals did not complete the trial. Overall, there were statistically significant reductions in the number of drinks per drinking day and the number of heavy-drinking days, and there was an increase in the number of abstinent days. Significant decreases in anxiety and craving were also shown. CONCLUSIONS: These findings suggest that baclofen is reasonably tolerated in an alcohol-dependent population, although the high dropout rate in the study is of concern. Baclofen may be effective for the reduction of drinking, anxiety, and craving for some alcohol-dependent individuals. A larger-scale placebo-controlled study is needed to further explore these effects and to determine the characteristics of those who respond to this medication.
Authors: Zachary A Rodd; Kristin K Anstrom; Darin J Knapp; Ildiko Racz; Andreas Zimmer; Salvatore Serra; Richard L Bell; Donald J Woodward; George R Breese; Giancarlo Colombo Journal: Alcohol Clin Exp Res Date: 2005-07 Impact factor: 3.455
Authors: Giovanni Addolorato; Antonio Mirijello; Lorenzo Leggio; Anna Ferrulli; Raffaele Landolfi Journal: CNS Drugs Date: 2013-04 Impact factor: 5.749