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

HIV Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01377168
• Other study ID #: XR-NTX ETOH
• Status: Completed
• Phase: Phase 4
• First received: June 17, 2011
• Last updated: June 14, 2017
• Start date: May 2014
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 159
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Disease
• HIV

Intervention

Drug:
• oral naltrexone

• Placebo pill

Locations

Country	Name	City	State
Peru	Asociación Civil Impacta Salud y Educación	Lima

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	Asociación Civil Impacta Salud y Educación, Peru, Yale University

Country where clinical trial is conducted

Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HIV Viral Load Suppression	The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.	6 months
Secondary	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.	6 months