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

Sponsor
Fred Hutchinson Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT01377168
Collaborator
Yale University (Other), Asociación Civil Impacta Salud y Educación, Peru (Other)
159
Enrollment
1
Location
2
Arms
37
Duration (Months)
4.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Drug: oral naltrexone
  • Drug: Placebo pill
 Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
159 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Study Start Date :
May 1, 2014
Actual Primary Completion Date :
Jun 1, 2016
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo pill

Daily oral placebo.

Drug: Placebo pill
Active Comparator: NTX

Daily oral naltrexone.

Drug: oral naltrexone
Other Names:
  • Nalerona

    		•

    Outcome Measures

    Primary Outcome Measures

    1. HIV Viral Load Suppression [6 months]

      The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.

    Secondary Outcome Measures

    1. ART Compliance and Alcohol Use Behavior [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Asociación Civil Impacta Salud y Educación Lima Peru

    Sponsors and Collaborators

    • Fred Hutchinson Cancer Center
    • Yale University
    • Asociación Civil Impacta Salud y Educación, Peru

    Investigators

    • Principal Investigator: Ann Duerr, MD, PhD, MPH, Fred Hutchinson Cancer Center
    • Study Director: Frederick Altice, MD, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ann C Duerr, Member, Fred Hutchinson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT01377168
    Other Study ID Numbers:
    • XR-NTX ETOH
    First Posted:
    Jun 21, 2011
    Last Update Posted:
    Jun 16, 2017
    Last Verified:
    Jun 1, 2017
    Additional relevant MeSH terms:
    Alcoholism
    Alcohol Drinking
    Naltrexone

    Study Results

    No Results Posted as of Jun 16, 2017