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

Fred Hutchinson Cancer Center159 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

159

Conditions

HIV Alcohol Use Disorder

Interventions

Eligibility

Sex: MALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

HIV Viral Load Suppression

The primary outcome will be the proportion with a VL\<400 copies/mL at 6 months.

Time frame: 6 months

Secondary Outcomes

ART Compliance and Alcohol Use Behavior

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.