Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Phase 2

Completed

• Conditions: Reduction in Heavy Drinking in Patients With HIV
• Interventions: Drug: Naltrexone; Other: Placebo + Medication Management/Medication Coaching

• Registration Number: NCT01227044
• Lead Sponsor: Yale University

Brief Summary

This is a double-blind placebo-controlled study to evaluate the effect of Naltrexone (NTX) and counseling on highly active antiretroviral treatment (HAART) medication adherence in a cohort of HIV-infected patients who report heavy drinking, or meet criteria for alcohol abuse and/or dependence, and inadequate (\< 95%) HAART adherence. All patients will receive a behavioral intervention, termed Medical Management/Medication Coaching or MM/MC. MM/MC incorporates the behavioral platform Medical Management (MM) from the National Institute on Alcohol Abuse and Alcoholism (NIAAA)-funded COMBINE Study to reduce heavy alcohol use with Medication Coaching (MC), a manualized treatment designed to improve HAART medication adherence in HIV-infected patients with substance use disorders.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-20
• Study First Submitted QC: 2010-10-20
• Study First Posted: 2010-10-22
• Study Start: 2011-04
• Primary Completion: 2017-08
• Study Completion: 2017-08
• Results First Submitted: 2019-01-24
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-20
• Last Update Submitted: 2019-03-20
• Results First Posted: 2019-03-21
• Last Update Posted: 2019-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

1. Be HIV-infected.
2. Currently be prescribed HAART medication or be eligible to receive HAART medication.
3. Report less than 95% adherence to their HAART medication.
4. Report heavy drinking 4 or more times in the past 4 weeks, or meet current criteria for alcohol abuse or dependence. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on one occasion.
5. Be at least 18 years old.
6. Be able to understand English and provide informed consent.

Exclusion Criteria

1. Be psychotic or severely psychiatrically disabled.

2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)

3. Have medical conditions that would preclude completing or be of harm during the course of the study.

4. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 5 times the upper limit of the normal range) or cirrhosis with a Child-Pugh classification greater than A or B.

5. Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).

6. Be pregnant, nursing or unable to use an effective method of birth control (women).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NTX + MM/MC	Naltrexone	Naltrexone + Medical Management/Medication Coaching
Placebo + MM/MC	Placebo + Medication Management/Medication Coaching	Placebo plus Medical Management/Medication Coaching

Primary Outcome Measures

Name	Time	Method
HAART Adherence	One year	The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.

Secondary Outcome Measures

Name	Time	Method
Heavy Drinking Days	One year	This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.

Trial Locations

Locations (2)

Yale University School of Medicine; 🇺🇸 New Haven, Connecticut, United States

VACT Healthcare System; 🇺🇸 New Haven, Connecticut, United States