Trial Information
Extended Release Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
HIV Viral Load Suppression
Outcome Description:
The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
Outcome Time Frame:
6 months
Safety Issue:
No
Principal Investigator
Ann Duerr, MD, PhD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
Fred Hutchinson Cancer Research Center
Authority:
United States: Institutional Review Board
Study ID:
XR-NTX ETOH
NCT ID:
NCT01377168
Start Date:
August 2013
Completion Date:
December 2016
Related Keywords:
- HIV
- Alcohol Use Disorder
- Alcohol Drinking