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

This study is not yet open for participant recruitment.
Verified January 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborators:
Yale University
Asociación Civil Impacta Salud y Educación, Peru
Information provided by (Responsible Party):
Duerr, Ann C, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01377168
First received: June 17, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
HIV
Alcohol Use Disorder
Drug: oral naltrexone
Drug: Placebo pill
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • HIV Viral Load Suppression [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 152
Study Start Date: January 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo pill
Daily oral placebo.
Drug: Placebo pill
Active Comparator: NTX
Daily oral naltrexone.
Drug: oral naltrexone
Other Name: Nalerona

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01377168

Locations
Peru
Asociación Civil Impacta Salud y Educación Not yet recruiting
Lima, Peru
Principal Investigator: Pedro Gonzales, MD         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Yale University
Asociación Civil Impacta Salud y Educación, Peru
Investigators
Principal Investigator: Ann Duerr, MD, PhD, MPH Fred Hutchinson Cancer Research Center
Study Director: Frederick Altice, MD Yale University
  More Information

No publications provided

Responsible Party: Duerr, Ann C, Member, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01377168     History of Changes
Other Study ID Numbers: XR-NTX ETOH
Study First Received: June 17, 2011
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board
Peru: Ethics Committee

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 14, 2014