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

NCT ID: NCT01377168

Last Updated: 2017-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

159 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2017-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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HIV Alcohol Use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo pill

Daily oral placebo.

Group Type PLACEBO_COMPARATOR

Placebo pill

Intervention Type DRUG

NTX

Daily oral naltrexone.

Group Type ACTIVE_COMPARATOR

oral naltrexone

Intervention Type DRUG

Interventions

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oral naltrexone

Intervention Type DRUG

Placebo pill

Intervention Type DRUG

Other Intervention Names

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Nalerona

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Asociación Civil Impacta Salud y Educación, Peru

OTHER

Sponsor Role collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Ann C Duerr

Member

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ann Duerr, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Frederick Altice, MD

Role: STUDY_DIRECTOR

Yale University

Locations

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Asociación Civil Impacta Salud y Educación

Lima, , Peru

Site Status

Countries

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Peru

Other Identifiers

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XR-NTX ETOH

Identifier Type: -

Identifier Source: org_study_id

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