Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
This trial is active, not recruiting.
|Conditions||hiv, alcohol use disorder|
|Treatments||oral naltrexone, placebo pill|
|Sponsor||Fred Hutchinson Cancer Research Center|
|Start date||May 2014|
|End date||June 2016|
|Trial size||159 participants|
|Trial identifier||NCT01377168, XR-NTX ETOH|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Daily oral placebo.
Daily oral naltrexone.
HIV Viral Load Suppression
time frame: 6 months
ART Compliance and Alcohol Use Behavior
time frame: 6 months
Male participants at least 18 years old.
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.
|Official title||Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder|
|Principal investigator||Ann Duerr, MD, PhD, MPH|
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