Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Overview
- Phase
- Phase 2
- Intervention
- Placebo + Medication Management/Medication Coaching
- Conditions
- Reduction in Heavy Drinking in Patients With HIV
- Sponsor
- Yale University
- Enrollment
- 51
- Locations
- 2
- Primary Endpoint
- HAART Adherence
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Be HIV-infected.
- •Currently be prescribed HAART medication or be eligible to receive HAART medication.
- •Report less than 95% adherence to their HAART medication.
- •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.
- •Be at least 18 years old.
- •Be able to understand English and provide informed consent.
Exclusion Criteria
- •Be psychotic or severely psychiatrically disabled.
- •Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g. Alcoholics Anonymous)
- •Have medical conditions that would preclude completing or be of harm during the course of the study.
- •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.
- •Have a known contraindication to NTX therapy (e.g. requiring opioid medication for pain).
- •Be pregnant, nursing or unable to use an effective method of birth control (women).
Arms & Interventions
Placebo + MM/MC
Placebo plus Medical Management/Medication Coaching
Intervention: Placebo + Medication Management/Medication Coaching
NTX + MM/MC
Naltrexone + Medical Management/Medication Coaching
Intervention: Naltrexone
Outcomes
Primary Outcomes
HAART Adherence
Time Frame: 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 Outcomes
- Heavy Drinking Days(One year)