Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
Sponsored by Johns Hopkins University
The proposed randomized clinical trial will investigate a novel pharmacotherapy for hazardous drinking, HIV-infected men and women, using the 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.
Subjects will be at least 18 years old and HIV-infected
All subjects will be actively drinking at hazardous levels (1) AUDIT score => 4 for women or =>8 for men, or 2) => 2 binge drinking episodes/month, or 3) >7 drinks/week for women or >14 drinks/week for men)
LFTs > 5 X normal
Magnesium or potassium > 3 X normal
Qtc => .460 and or a family history of LQT
Inability to read and comprehend English
Actively psychotic or other severe mental health symptoms that would prevent appropriate participation
Current enrollment in alcoholism treatment program
Pregnancy; Ondansetron is currently a category B drug. While animal data have not identified any harmful effects to mother or fetus, there have not been adequate human controlled trials to recommend routine use in this population
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