At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Ondansetron Pharmacotherapy for Hazardous Drinking in HIV+, African-American Women
In Brief
A Phase 2 clinical trial evaluating ondansetron, placebo ondansetron, and 1 other intervention for Alcohol Abuse and Alcohol Dependence. Completed, enrolled 357 participants across 1 site.
Detailed Summary
The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous drinking, HIV-infected men and women, using the serotonin receptor (5-HT3) antagonist ondansetron. The investigators predict that participants who are treated with active doses of ondansetron will reduce their drinking more and show better HIV treatment participation and progress compared to participants who are treated with placebo. This study will provide important new safety and efficacy results on drinking and HIV outcomes following alcohol pharmacotherapy in HIV-infected persons.
Study Details
Timeline
Interventions
ondansetron 0.2 mg bid, oral preparation, 16 weeks
Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.
Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration