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

NCT01377168 | Completed Phase 4

• 1 other identifier: XR-NTX ETOH
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

HIV; Alcohol Use Disorder

Outcome Measures

Primary Outcomes (1)

• HIV Viral Load Suppression

  The primary outcome will be the proportion with a VL\<400 copies/mL at 6 months.

  6 months

Secondary Outcomes (1)

• ART Compliance and Alcohol Use Behavior

  6 months

Study Arms (2)

Placebo pill

PLACEBO COMPARATOR

Daily oral placebo.

Drug: Placebo pill

NTX

ACTIVE COMPARATOR

Daily oral naltrexone.

Drug: oral naltrexone

Interventions

oral naltrexone DRUG

Also known as: Nalerona

NTX

Placebo pill DRUG

Placebo pill

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead
• Yale University: collaborator
• Asociación Civil Impacta Salud y Educación, Peru: collaborator

Study Sites (1)

Asociación Civil Impacta Salud y Educación

Lima, Peru

Location

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Ann Duerr, MD, PhD, MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

• Frederick Altice, MD

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Member

Study Record Dates

• First Submitted: June 17, 2011
• First Posted: June 21, 2011
• Study Start: May 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2017
• Last Updated: June 16, 2017

Record last verified: 2017-06

Locations

PE (1)