Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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.
Alcohol Use Disorder
Drug: oral naltrexone
Drug: Placebo pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder|
- HIV Viral Load Suppression [ Time Frame: 6 months ] [ Designated as safety issue: No ]The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
- ART Compliance and Alcohol Use Behavior [ Time Frame: 6 months ] [ Designated as safety issue: No ]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.
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo pill
Daily oral placebo.
|Drug: Placebo pill|
Active Comparator: NTX
Daily oral naltrexone.
Drug: oral naltrexone
Other Name: Nalerona
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377168
|Asociación Civil Impacta Salud y Educación||Recruiting|
|Contact: Pedro Gonzales, MD firstname.lastname@example.org|
|Contact: Javier Lama, MD, MPH email@example.com|
|Principal Investigator: Pedro Gonzales, MD|
|Principal Investigator:||Ann Duerr, MD, PhD, MPH||Fred Hutchinson Cancer Research Center|
|Study Director:||Frederick Altice, MD||Yale University|