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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 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 51 participants.

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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.

Interventions

  • DRUG Naltrexone
  • OTHER Placebo + Medication Management/Medication Coaching

Trial Details

FieldValue
Enrollment Target 51 participants
Start Date 2011-04
Est. Completion 2017-08
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT01227044

The ClinicalTrials.gov registry entry for NCT01227044 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Naltrexone is the first listed.

NCT01227044 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.