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NCT01254877 · ClinicalTrials.gov registry record · Phase 2
Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons
A Phase 2 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 2
- Development phase
- 357
- Enrollment target
NCT01254877: Completed Phase 2 study, sponsored by Johns Hopkins University.
NCT01254877 is a Phase 2 study that has completed, run by Johns Hopkins University. The registered enrollment target is 357 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01254877, a Phase 2 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 357 participants
- Enrollment target
Study 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.
Primary Outcome
The Time-line Follow-back (TLFB; Sobell, Sobell, Leo \& Cancilla, 1988) is conducted as an interview administered by trained and certified research staff. The interview obtains participant self-reports of daily drinking, including number and type of alcoholic beverages. These data are used to quantify an individual's drinking pattern including the number of drinks per drinking day and drinking frequency. The TLFB was completed biweekly and quantified over the 16-week medication period
Interventions
- DRUG Ondansetron
- DRUG ondansetron
- DRUG placebo ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 357 participants |
| Start Date | 2010-12 |
| Est. Completion | 2017-01 |
| Phase | Phase 2 |
What the finished NCT01254877 record still lists
NCT01254877 is an interventional study that assigns participants to a tested intervention. The registered 357 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (168% higher).
The record links to 0 conditions, and to 3 interventions - of which Ondansetron is the first listed.
NCT01254877 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01254877 about?
NCT01254877 is a clinical study titled "Ondansetron, Alcohol Use, and Alcohol-Related Symptoms In HIV+ Persons". 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 th...
What is the current status of trial NCT01254877?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 357 participants. The study started on 2010-12. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01254877?
The interventions under investigation include: Ondansetron (DRUG), ondansetron (DRUG), placebo ondansetron (DRUG).
Who is sponsoring clinical trial NCT01254877?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01254877's enrollment target sits among peer trials
357 127th of 2000 higher than 1,873 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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