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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01377168

Enrollment

159

Registered

2011-06-21

Start date

2014-05-31

Completion date

2017-06-30

Last updated

2017-06-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV, Alcohol Use Disorder

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.

Interventions

DRUGoral naltrexone

DRUGPlacebo pill

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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.

Countries

Peru

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026