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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 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: July 5, 2014
Last verified: July 2014

June 17, 2011
July 5, 2014
May 2014
December 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01377168 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • HIV
  • Alcohol Use Disorder
  • Drug: oral naltrexone
    Other Name: Nalerona
  • Drug: Placebo pill
  • Placebo Comparator: Placebo pill
    Daily oral placebo.
    Intervention: Drug: Placebo pill
  • Active Comparator: NTX
    Daily oral naltrexone.
    Intervention: Drug: oral naltrexone
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
152
December 2016
December 2016   (final data collection date for primary outcome measure)

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.
Male
18 Years and older
No
Peru
 
NCT01377168
XR-NTX ETOH
No
Duerr, Ann C, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
  • Yale University
  • Asociación Civil Impacta Salud y Educación, Peru
Principal Investigator: Ann Duerr, MD, PhD, MPH Fred Hutchinson Cancer Research Center
Study Director: Frederick Altice, MD Yale University
Fred Hutchinson Cancer Research Center
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP