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Extended Release Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder


Phase 4
18 Years
N/A
Not Enrolling
Male
HIV, Alcohol Use Disorder

Thank you

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

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