Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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ClinicalTrials.gov Identifier: NCT01377168
Recruitment Status :
First Posted : June 21, 2011
Last Update Posted : June 16, 2017
Fred Hutchinson Cancer Research Center
Asociación Civil Impacta Salud y Educación, Peru
Information provided by (Responsible Party):
Ann C Duerr, Fred Hutchinson Cancer Research Center
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.
HIV Viral Load Suppression [ Time Frame: 6 months ]
The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
Secondary Outcome Measures :
ART Compliance and Alcohol Use Behavior [ Time Frame: 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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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.