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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alcohol Abuse, Alcohol Dependence

In brief

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.

Key facts

Study ID

NCT01254877

Run by

Johns Hopkins University

People needed

357

Starts

2010-12-01

Expected to finish

2017-01-01

Last updated by the study team

2018-04-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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