Clinical efficacy of the 5-HT3 antagonist ondansetron in alcohol abuse and dependence

• Published in: Alcoholism, clinical and experimental research Vol. 18; no. 4; p. 879
• Main Authors: Sellers, E M, Toneatto, T, Romach, M K, Somer, G R, Sobell, L C, Sobell, M B
• Format: Journal Article
• Language: English
• Published: England 01.08.1994
• Subjects: Adult; Alcoholism - rehabilitation; Dose-Response Relationship, Drug; Double-Blind Method; Follow-Up Studies; Humans; Male; Middle Aged; Ondansetron - administration & dosage; Ondansetron - adverse effects; Receptors, Serotonin - classification; Receptors, Serotonin - drug effects
• ISSN: 0145-6008
• DOI: 10.1111/j.1530-0277.1994.tb00054.x

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.