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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01377168
Recruitment Status : Completed
First Posted : June 21, 2011
Last Update Posted : June 16, 2017
Yale University
Asociación Civil Impacta Salud y Educación, Peru
Information provided by (Responsible Party):
Ann C Duerr, Fred Hutchinson Cancer Research Center

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

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Study Type : Interventional  (Clinical Trial)
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 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol HIV/AIDS

Arm Intervention/treatment
Placebo Comparator: Placebo pill
Daily oral placebo.
Drug: Placebo pill
Active Comparator: NTX
Daily oral naltrexone.
Drug: oral naltrexone
Other Name: Nalerona

Primary Outcome Measures :
  1. HIV Viral Load Suppression [ Time Frame: 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 [ Time Frame: 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01377168

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Asociación Civil Impacta Salud y Educación
Lima, Peru
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Yale University
Asociación Civil Impacta Salud y Educación, Peru
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Principal Investigator: Ann Duerr, MD, PhD, MPH Fred Hutchinson Cancer Research Center
Study Director: Frederick Altice, MD Yale University
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Responsible Party: Ann C Duerr, Member, Fred Hutchinson Cancer Research Center Identifier: NCT01377168    
Other Study ID Numbers: XR-NTX ETOH
First Posted: June 21, 2011    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017
Additional relevant MeSH terms:
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Alcohol Drinking
Drinking Behavior
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Alcohol Deterrents
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents