Status:
COMPLETED
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Reduction in Heavy Drinking in Patients With HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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-infe...
Eligibility Criteria
Inclusion
- 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
- 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).
- \-
Key Trial Info
Start Date :
April 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
51 Patients enrolled
Trial Details
Trial ID
NCT01227044
Start Date
April 1 2011
End Date
August 1 2017
Last Update
March 21 2019
Active Locations (2)
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1
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
2
VACT Healthcare System
New Haven, Connecticut, United States, 06516