Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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|ClinicalTrials.gov Identifier: NCT01377168|
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 16, 2017
|Condition or disease||Intervention/treatment||Phase|
|HIV Alcohol Use Disorder||Drug: oral naltrexone Drug: Placebo pill||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||159 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder|
|Study Start Date :||May 2014|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2017|
Placebo Comparator: Placebo pill
Daily oral placebo.
|Drug: Placebo pill|
Active Comparator: NTX
Daily oral naltrexone.
Drug: oral naltrexone
Other Name: Nalerona
- HIV Viral Load Suppression [ Time Frame: 6 months ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01377168
|Asociación Civil Impacta Salud y Educación|
|Principal Investigator:||Ann Duerr, MD, PhD, MPH||Fred Hutchinson Cancer Research Center|
|Study Director:||Frederick Altice, MD||Yale University|