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

Sponsored by Johns Hopkins University

Phase Quota
Phase 2

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.

Study Start Date: December 2010

Estimated Completion Date: August 2016

Specialties: Infectious Disease: HIV/Immunodeficiency Pharmacy: Drug Trials,Neuro/Psych pharmacology Psychiatry: Neuro/Psych Pharmacol,Substance Abuse

Interventions

  • Drug: placebo ondansetron
  • Drug: ondansetron
  • Drug: Ondansetron

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

  • 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

Study Locations And Contact Information

  • Johns Hopkins Hospital, Baltimore Maryland
  • Johns Hopkins Hospital, Baltimore Maryland

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