Clinical efficacy of the 5-HT3 antagonist ondansetron in alcohol abuse and dependence.
Medications that act on the serotonergic system have been found to be of benefit in the treatment of alcohol-dependent individuals. In a randomized, placebo-controlled study, the efficacy of 6 weeks of ondansetron, a 5-HT3 antagonist (0.25 mg bid or 2.0 mg bid), in the treatment of 71 nonseverely alcohol-dependent males was tested. The results showed reduction of drinking differences were steadily increasing toward the end of the treatment period approached significance at week 7 in the 0.25 mg group (p = 0.06). Twice as many patients in this group showed > or = 2 standard deviations decrease in drinking compared with the other groups. When patients drinking > 10 drinks/drinking day at baseline (n = 11) were excluded from the analysis, significant group differences were found at both treatment and follow-up, with the lower ondansetron dose producing the greatest reduction from baseline (i.e., 2.8 standard drinks; -35% compared with baseline and -21% compared with placebo; p < 0.02-0.001). Within this group, there was an almost 4-fold greater number of patients showing a clinically meaningful decrease in drinking. Lower baseline drinking and higher level of education were significant and strong predictors of drinking reduction during treatment. Ondansetron was very well tolerated; hence, further long-term studies with 5-HT3 antagonists alone or in combination with other treatment components may offer promise for treatment of alcoholism.
Mental Health Unit, University of Toronto, Ontario, Canada.
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Sellers
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Toneatto
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Romach
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Somer
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Sobell
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Sobell
D000328:Adult; D000437:Alcoholism / Q000534:rehabilitation*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D017294:Ondansetron / Q000008:administration & dosage* / Q000009:adverse effects; D011985:Receptors, Serotonin / Q000145:classification / Q000187:drug effects
D011985:Receptors, Serotonin; D017294:Ondansetron