Pharmacotherapy for HIV Infected Patients With Alcohol Problems

VA Connecticut Healthcare System

Overview

This is a randomized double blind clinical trial to test the effect of Naltrexone on HIV infected heavy drinkers. The study will select 40 HIV positive patients who meet criteria for heavy drinking. Treatments include Naltrexone (25-100mg)and placebo. Patients will be treated, followed up, and assessed for a duration of 12 weeks. The investigators associated hypotheses Hypothesis 1: Naltrexone will reduce the frequency of heavy drinking. Hypothesis 2: Naltrexone will lead to maintenance or improvement in CD4 lymphocyte count and decreased HIV RNA levels. Hypothesis 3: Naltrexone will lead to a reduction in sexual risk behaviors. Hypothesis 4: Naltrexone will lead to improved adherence to HAART. Hypothesis 5 (Exploratory): Naltrexone will be well-tolerated with minimal side effects and patients will exhibit good treatment retention.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

HIV Infection Heavy Alcoholic Consumption HIV Infections

Interventions

NaltrexoneDRUG

Naltrexone dose 25-100mg

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be HIV-positive. 2. Report heavy drinking 4 or more times in the past 4 weeks. Heavy drinking is defined as 4 or more drinks for women and 5 or more drinks for men on any occasion. 3. Not be abstinent from alcohol for greater than 30 days. 4. Be at least 18 years old. 5. Be able to understand English and provide informed consent Exclusion Criteria: 1. Be psychotic or severely psychiatrically disabled. 2. Have medical conditions that would preclude completing or be of harm during the course of the study. 3. Have laboratory or clinical evidence of significant liver dysfunction (alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of the normal range) or cirrhosis. 4. Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain). 5. Be pregnant, nursing or unable to use an effective method of birth control (women). 6. Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.

Outcomes

Primary Outcomes

Frequency of heavy drinking

Time frame: 12 weeks

Secondary Outcomes

HIV biological markers

Time frame: 12 weeks

Sexual risk behavior

Time frame: 12 weeks

Tolerability and retention in alcohol treatment

Time frame: 12 weeks

Data from ClinicalTrials.gov

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