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Randomized Controlled Trial
. 2015 Jan;232(1):233-43.
doi: 10.1007/s00213-014-3652-9. Epub 2014 Jun 29.

A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

Lorenzo Leggio  1 , William H Zywiak, Steven M Edwards, Jennifer W Tidey, Robert M Swift, George A Kenna
Affiliations
Randomized Controlled Trial

A preliminary double-blind, placebo-controlled randomized study of baclofen effects in alcoholic smokers

Lorenzo Leggio et al. Psychopharmacology (Berl). 2015 Jan.

Erratum in

Abstract

Rationale: There is presently no approved single treatment for dual alcohol and nicotine dependencies.

Objective: This pilot study investigated baclofen effects in alcoholic smokers.

Methods: This was a preliminary double-blind placebo-controlled randomized clinical study with 30 alcoholic smokers randomized to baclofen at 80 mg/day or placebo. A subgroup (n=18) participated in an alcohol cue-reactivity experiment.

Results: Baclofen, compared with placebo, significantly decreased the percent days of abstinence from alcohol-tobacco co-use (p=0.004). Alcohol dependence severity moderated baclofen effects, with the higher severity group having the greater baclofen response (p<0.001). Although the percent days of alcohol-tobacco co-use declined in both groups, this decline was greater after placebo than baclofen (p<0.001). Secondary analyses on alcohol or tobacco use alone suggested that the increase in percent days of co-abstinence was driven by the medication differences on heavy drinking days and on percent days smoking. In the cue-reactivity substudy, baclofen slightly decreased alcohol urge (p=0.058) and significantly reduced salivation (p=0.001), but these effects were not related to cue type.

Conclusions: This study provides preliminary evidence suggesting a possible role of baclofen in the treatment of alcoholic smokers. However, the mixed results and the small sample require larger confirmatory studies.

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Conflict of interest statement

Conflict of interest Dr. Swift has received travel and honorarium from D&A Pharma, and consultant fees from CT Laboratories. Dr. Kenna has received consultant fees from CT Laboratories. The other authors report no biomedical financial interests or potential conflicts of interest.

Figures

Fig. 1
Fig. 1
Effects of baclofen vs. placebo on the percent days of abstinence from alcohol-tobacco co-use (a), tobacco (b), and alcohol (c)
Fig. 2
Fig. 2
Effects of baclofen vs. placebo on the percent days of alcohol-tobacco co-use
Fig. 3
Fig. 3
Effects of baclofen vs. placebo on salivation following water vs. alcohol cues
See this image and copyright information in PMC

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