Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

Phase 4

Completed

• Conditions: Alcohol Use Disorder; HIV
• Interventions: Drug: Placebo pill; Drug: oral naltrexone

• Registration Number: NCT01377168
• Lead Sponsor: Fred Hutchinson Cancer Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-06-17
• Study First Submitted QC: 2011-06-17
• Study First Posted: 2011-06-21
• Study Start: 2014-05
• Primary Completion: 2016-06
• Status Verified: 2017-06
• Study Completion: 2017-06
• Last Update Submitted: 2017-06-14
• Last Update Posted: 2017-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 159

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo pill	Placebo pill	Daily oral placebo.
NTX	oral naltrexone	Daily oral naltrexone.

Primary Outcome Measures

Name	Time	Method
HIV Viral Load Suppression	6 months	The primary outcome will be the proportion with a VL\<400 copies/mL at 6 months.

Secondary Outcome Measures

Name	Time	Method
ART Compliance and Alcohol Use Behavior	6 months	Secondary HIV outcomes will include time to ART initiation, retention on ART over 6 months, and HIV sexual risk behaviors. Alcohol use outcomes include the following: 1) Time to relapse to heavy drinking (for men defined as \>5 drinks/drinking day); 2) percent of days drinking (PDD) over the six-month examination period; 3) percent of days abstinent (PDA) over the six month examination period; and 4) alcohol craving using the Obsessive Compulsive Drinking Scale where a mean change in total score will be assessed and compared between treatment groups.

Trial Locations

Locations (1)

Asociación Civil Impacta Salud y Educación; 🇵🇪 Lima, Peru