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Ritanserin in the treatment of alcohol dependence--a multi-center clinical trial. Ritanserin Study Group
B A Johnson1, D R Jasinski, G P Galloway
1Clinical Laboratory, University of Texas, Health Science Center at Houston 77030, USA.
Psychopharmacology
|November 1, 1996
Summary
This study found that while ritanserin did not significantly reduce alcohol intake or craving compared to placebo, all participants showed clinical improvement in a structured treatment program. Further research is needed for effective alcohol dependence therapies.
Area of Science:
- Neuroscience
- Psychiatry
- Clinical Pharmacology
Background:
- Alcohol dependence is a significant public health issue with ongoing needs for effective pharmacological interventions.
- The 5-HT2 receptor antagonist ritanserin has been investigated for potential therapeutic effects in various conditions.
Purpose of the Study:
- To evaluate the safety and efficacy of ritanserin in reducing alcohol consumption and craving among alcohol-dependent individuals.
- To compare different dosages of ritanserin against a placebo within a cognitive-behavioral therapy framework.
Main Methods:
- A 12-week randomized, double-blind, placebo-controlled trial involving 423 alcohol-dependent subjects.
- Subjects received a 1-week single-blind placebo phase followed by an 11-week double-blind treatment phase with ritanserin (2.5 mg/day or 5 mg/day) or placebo.
- All participants received weekly manual-guided cognitive-behavioral therapy sessions.
Main Results:
- All treatment groups demonstrated significant reductions in drinks per day, drinking days per week, drinks per drinking day, and alcohol craving.
- No statistically significant differences were observed between ritanserin treatment groups and the placebo group for any primary outcome measures.
- Ritanserin treatment was associated with a dose-related prolongation of the QTc interval, indicating a potential safety concern.
Conclusions:
- While ritanserin did not show superior efficacy over placebo in reducing alcohol intake or craving, the study highlights the potential for marked clinical improvement in alcohol-dependent subjects within structured treatment programs.
- The findings do not support a significant role for ritanserin as a primary treatment for alcohol dependence, particularly given the observed QTc prolongation.