Phase 2
N=205
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
Alcohol Abuse · Alcohol Dependence
Bottom Line
View on ClinicalTrials.gov: NCT01254877 ↗Enrolled (actual)
205
Serious AEs
20.0%
Results posted
Apr 2018
Primary outcome: Primary: Number of Alcoholic Containing Drinks Per Drinking Day — 5.9; 6.1; 5.9 Standard alcohol drinks per drinking day
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ondansetron (Drug); placebo ondansetron (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johns Hopkins University
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Alcoholic Containing Drinks Per Drinking Day |
5.9; 6.1; 5.9 | — |
| PRIMARY Number of Days/Week Abstinent From Alcohol |
4.7; 4.9; 4.8 | — |
| SECONDARY Medication Safety |
11.4; 12.4; 11.0 | — |
| SECONDARY Number of Subjects Who Discontinue Due to Side Effects |
0; 0; 0 | — |
| SECONDARY Alcohol-related Problems |
6.6; 7.5; 8.3 | — |
| SECONDARY HIV Medication Adherence |
92.4; 87.6; 85.4 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01254877). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.