Status:
WITHDRAWN
Pharmacotherapy for HIV Infected Patients With Alcohol Problems
Lead Sponsor:
VA Connecticut Healthcare System
Collaborating Sponsors:
Yale University
Conditions:
HIV Infection
Heavy Alcoholic Consumption
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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. T...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00854230
Start Date
January 1 2009
End Date
January 1 2010
Last Update
March 28 2012
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