Status:
COMPLETED
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Alcohol Abuse
Alcohol Dependence
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 inv...
Detailed Description
Hazardous drinking is particularly harmful in HIV-infected persons. It impairs the immune system, accelerates HIV disease progression, slows initiation of antiretroviral therapy (ART) and decreases ad...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT01254877
Start Date
December 1 2010
End Date
January 1 2017
Last Update
April 17 2018
Active Locations (1)
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1
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205