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

This study is not yet open for participant recruitment.

Verified December 2012 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: December 28, 2012

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2011

Last Updated Date

December 28, 2012

Start Date ^ICMJE

March 2013

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01377168 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

This study will recruit 152 HIV-infected men with alcohol use disorders (AUDs). Men will be randomized to receive either extended release-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 extended release-naltrexone or placebo. The purpose of this study is to see whether use of extended release-naltrexone improves medication compliance, and therefore HIV viral load suppression, among men with alcohol use disorder. The study will also assess the impact of extended release-naltrexone on alcohol use behaviors in this population.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

HIV
Alcohol Use Disorder

Intervention ^ICMJE

Drug: Extended release-naltrexone
Other Name: Vivitrol
Drug: Placebo injection

Study Arm (s)

Placebo Comparator: Placebo injection
Monthly placebo injection.

Intervention: Drug: Placebo injection
Active Comparator: NTX-XR
Monthly depo-naltrexone injection.

Intervention: Drug: Extended release-naltrexone

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

152

Estimated Completion Date

December 2016

Estimated Primary Completion Date

December 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Not Provided

Location Countries ^ICMJE

Peru

Administrative Information

NCT Number ^ICMJE

NCT01377168

Other Study ID Numbers ^ICMJE

XR-NTX ETOH

Has Data Monitoring Committee

Responsible Party

Duerr, Ann C, Fred Hutchinson Cancer Research Center

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

Yale University
Asociación Civil Impacta Salud y Educación, Peru

Investigators ^ICMJE

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

Information Provided By

Fred Hutchinson Cancer Research Center

Verification Date

December 2012

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

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