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

Primary Purpose

HIV, Alcohol Use Disorder

Status
Completed
Phase
Phase 4
Locations
Peru
Study Type
Interventional
Intervention
oral naltrexone
Placebo pill
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Asociación Civil Impacta Salud y Educación

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo pill

NTX

Arm Description

Daily oral placebo.

Daily oral naltrexone.

Outcomes

Primary Outcome Measures

HIV Viral Load Suppression
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
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.

Full Information

First Posted
June 17, 2011
Last Updated
June 14, 2017
Sponsor
Fred Hutchinson Cancer Center
Collaborators
Yale University, Asociación Civil Impacta Salud y Educación, Peru
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1. Study Identification

Unique Protocol Identification Number
NCT01377168
Brief Title
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Official Title
Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
Yale University, Asociación Civil Impacta Salud y Educación, Peru

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HIV, Alcohol Use Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
159 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo pill
Arm Type
Placebo Comparator
Arm Description
Daily oral placebo.
Arm Title
NTX
Arm Type
Active Comparator
Arm Description
Daily oral naltrexone.
Intervention Type
Drug
Intervention Name(s)
oral naltrexone
Other Intervention Name(s)
Nalerona
Intervention Type
Drug
Intervention Name(s)
Placebo pill
Primary Outcome Measure Information:
Title
HIV Viral Load Suppression
Description
The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
ART Compliance and Alcohol Use Behavior
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Duerr, MD, PhD, MPH
Organizational Affiliation
Fred Hutchinson Cancer Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Frederick Altice, MD
Organizational Affiliation
Yale University
Official's Role
Study Director
Facility Information:
Facility Name
Asociación Civil Impacta Salud y Educación
City
Lima
Country
Peru

12. IPD Sharing Statement

Learn more about this trial

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

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