Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• Liver Function Tests (LFTs) > 5 X normal

• Magnesium or potassium > 3 X normal

• Qtc => .460 and or a family history of long QT syndrome (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