Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Enrollment
Sex
Ages
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
159 participants in 2 patient groups, including a placebo group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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