Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Sponsor

VA Connecticut Healthcare System (U.S. Fed)

Overall Status

Withdrawn

CT.gov ID

NCT00854230

Collaborator

Yale University (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
HIV Infection Heavy Alcoholic Consumption HIV Infections	Drug: Naltrexone	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pharmacotherapy for HIV Infected Patients With Alcohol Problems

Study Start Date :

Jan 1, 2009

Actual Primary Completion Date :

Jan 1, 2010

Actual Study Completion Date :

Jan 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Naltrexone	Drug: Naltrexone Naltrexone dose 25-100mg Other Names: Revia
Placebo Comparator: 2	Drug: Naltrexone Naltrexone dose 25-100mg Other Names: Revia

Arm

Intervention/Treatment

Experimental: 1

Naltrexone

Drug: Naltrexone

Naltrexone dose 25-100mg

Other Names:

Revia

Placebo Comparator: 2

Drug: Naltrexone

Naltrexone dose 25-100mg

Other Names:

Revia

Outcome Measures

Primary Outcome Measures

Frequency of heavy drinking [12 weeks]

Secondary Outcome Measures

HIV biological markers [12 weeks]
Sexual risk behavior [12 weeks]
Tolerability and retention in alcohol treatment [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Be HIV-positive.
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.
Not be abstinent from alcohol for greater than 30 days.
Be at least 18 years old.
Be able to understand English and provide informed consent

Exclusion Criteria:

Be psychotic or severely psychiatrically disabled.
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 3 times the upper limit of the normal range) or cirrhosis.
Have a known contraindication to naltrexone therapy (e.g. taking opioid medication for pain).
Be pregnant, nursing or unable to use an effective method of birth control (women).
Subjects who are taking or use narcotics will not be included because naltrexone will precipitate withdrawal.