Overview

This trial is active, not recruiting.

Conditions hiv, alcohol use disorder
Treatments oral naltrexone, placebo pill
Phase phase 4
Sponsor Fred Hutchinson Cancer Research Center
Collaborator Yale University
Start date May 2014
End date June 2016
Trial size 159 participants
Trial identifier NCT01377168, XR-NTX ETOH

Summary

This study will recruit 159 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either oral naltrexone for the treatment of alcohol use disorder or placebo. Men with acute, recent or established HIV infection will receive antiretroviral treatment (ART) and be randomized to oral naltrexone or placebo. The purpose of this study is to see whether use of oral naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of oral naltrexone on alcohol use behaviors in this population.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Placebo Comparator)
Daily oral placebo.
placebo pill
(Active Comparator)
Daily oral naltrexone.
oral naltrexone Nalerona

Primary Outcomes

Measure
HIV Viral Load Suppression
time frame: 6 months

Secondary Outcomes

Measure
ART Compliance and Alcohol Use Behavior
time frame: 6 months

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Meets DSM-IV criteria for alcohol dependence or problem drinking. - Age 18 years and older - Confirmed HIV infection, either through positive HIV antibody or detectable HIV-1 RNA level. - No participation in pharmacotherapy trial in the previous 30 days - Not pregnant Exclusion Criteria: - Unable to provide informed consent - Verbally or physically threatening to research staff - Unable to communicate in Spanish - Pending trials for a felony - Childs-Pugh Class C Cirrhosis - Grade 3 Hepatitis (LFTs > 5X normal) - Receiving opioid prescription narcotics or has pain syndrome necessitating future use of opioid prescription narcotics.

Additional Information

Official title Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Principal investigator Ann Duerr, MD, PhD, MPH
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Fred Hutchinson Cancer Research Center.