Acute interaction of baclofen in combination with alcohol in heavy social drinkers.
BACKGROUND
There is growing evidence that gamma-amino butyric acid-B receptor agonists may be effective in the treatment of alcohol abuse or dependence. The primary goal of this study was to determine the safety of baclofen in combination with alcohol consumption in heavy drinkers. In addition, the effects of baclofen alone, and in combination with alcohol, on subjective effects, cognitive performance effects, as well as alcohol craving, were assessed.


METHODS
Eighteen non-treatment-seeking heavy social drinkers (mean of 28 drinks per week), who did not meet the criteria for alcohol dependence participated. All individuals were tested using a double-blind double-dummy design with six 2-day inpatient phases. Baclofen (0, 40, and 80 mg) was administered 2.5 hours before alcohol (1.5 g/l body water or approximately 0.75 g/kg) or placebo beverages, given in 4 divided doses every 20 minutes.


RESULTS
Baclofen, either alone or in combination with alcohol, produced only modest increases in heart rate and blood pressure and no adverse effects were reported. Baclofen did not increase positive subjective effects (e.g., Stimulant effects, Drug Liking) but did increase sedation and impair performance. Even though both baclofen and alcohol impaired performance, for the most part performance was not impaired to a greater extent when baclofen was combined with alcohol. Among this population of nondependent drinkers, baclofen did not alter alcohol craving or alcohol-induced positive subjective effects.


CONCLUSIONS
Baclofen alone has minimal abuse liability in heavy social drinkers, and baclofen is relatively well tolerated and safe when given in combination with intoxicating doses of alcohol.
New York State Psychiatric Institute, New York, New York 10032, USA. se18@columbia.edu
Suzette M
SM
Evans
Adam
A
Bisaga
D000328:Adult; D000428:Alcohol Drinking / Q000188:drug therapy / Q000378:metabolism*; D001418:Baclofen / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001944:Breath Tests / Q000379:methods; D004311:Double-Blind Method; D004347:Drug Interactions / Q000502:physiology; D000431:Ethanol / Q000008:administration & dosage / Q000493:pharmacokinetics*; D005260:Female; D006801:Humans; D008297:Male; D011597:Psychomotor Performance / Q000187:drug effects / Q000502:physiology; D012737:Sex Factors; D055815:Young Adult
D000431:Ethanol; D001418:Baclofen