- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01377168
Naltrexone for Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
June 14, 2017 updated by: Ann C Duerr, Fred Hutchinson Cancer Center
Oral Naltrexone for Improved Medication Compliance Among HIV-infected Men With Alcohol Use Disorder
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
159
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Lima, Peru
- Asociacion Civil IMPACTA Salud y Educacion
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: Placebo pill
Daily oral placebo.
|
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ACTIVE_COMPARATOR: NTX
Daily oral naltrexone.
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Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HIV Viral Load Suppression
Time Frame: 6 months
|
The primary outcome will be the proportion with a VL<400 copies/mL at 6 months.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
ART Compliance and Alcohol Use Behavior
Time Frame: 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ann Duerr, MD, PhD, MPH, Fred Hutchinson Cancer Center
- Study Director: Frederick Altice, MD, Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2014
Primary Completion (ACTUAL)
June 1, 2016
Study Completion (ACTUAL)
June 1, 2017
Study Registration Dates
First Submitted
June 17, 2011
First Submitted That Met QC Criteria
June 17, 2011
First Posted (ESTIMATE)
June 21, 2011
Study Record Updates
Last Update Posted (ACTUAL)
June 16, 2017
Last Update Submitted That Met QC Criteria
June 14, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- XR-NTX ETOH
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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