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

Study Overview
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Brief Summary
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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.

Official Title
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Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

Conditions
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HIV, Alcohol Use Disorder

Intervention / Treatment
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* Drug: oral naltrexone
* Drug: Placebo pill


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo pill<br>Daily oral placebo. | Drug: Placebo pill<br> <br> |
| Active Comparator: NTX<br>Daily oral naltrexone. | Drug: oral naltrexone<br> <br> * Other names: Nalerona;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HIV Viral Load Suppression | The primary outcome will be the proportion with a VL<400 copies/mL at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months |