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NCT01227044 · ClinicalTrials.gov registry record · Phase 2
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 51
- Enrollment target
NCT01227044: Completed Phase 2 study, sponsored by Yale University.
NCT01227044 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 51 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01227044, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 51 participants
- Enrollment target
Study Summary
This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (\< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.
Primary Outcome
The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.
Interventions
- DRUG Naltrexone
- OTHER Placebo + Medication Management/Medication Coaching
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2011-04 |
| Est. Completion | 2017-08 |
| Phase | Phase 2 |
What the finished NCT01227044 record still lists
NCT01227044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Naltrexone is the first listed.
NCT01227044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01227044 about?
NCT01227044 is a clinical study titled "Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention". This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and i...
What is the current status of trial NCT01227044?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2011-04. Estimated completion is 2017-08.
What interventions are being tested in trial NCT01227044?
The interventions under investigation include: Naltrexone (DRUG), Placebo + Medication Management/Medication Coaching (OTHER).
Who is sponsoring clinical trial NCT01227044?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01227044's enrollment target sits among peer trials
51 1190th of 2000 higher than 806 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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