Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Study Overview
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Brief Summary
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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.

Official Title
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Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Conditions
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Reduction in Heavy Drinking in Patients With HIV

Intervention / Treatment
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* Drug: Naltrexone
* Other: Placebo + Medication Management/Medication Coaching


Participation Criteria
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Eligibility Criteria
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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). -

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NTX + MM/MC<br>Naltrexone + Medical Management/Medication Coaching | Drug: Naltrexone<br>* NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.<br>* Other names: Vivitrol;|
| Placebo Comparator: Placebo + MM/MC<br>Placebo plus Medical Management/Medication Coaching | Other: Placebo + Medication Management/Medication Coaching<br>* Placebo + Medication Management/Medication Coaching<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HAART Adherence | 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. | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heavy Drinking Days | 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. | One year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Substance Abuse Counseling, Adherence (medication), Alcohol Abuse, Highly Active Antiretroviral Therapy (HAART), Naltrexone, Vivitrol, HIV