Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Completed · Phase 2/Phase 3 · Has a placebo group
Conditions studied: Reduction in Heavy Drinking in Patients With HIV
In brief
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.
Key facts
- Study ID
- NCT01227044
- Run by
- Yale University
- People needed
- 51
- Starts
- 2011-04-01
- Expected to finish
- 2017-08-01
- Last updated by the study team
- 2019-03-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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).
Where it is running
- Yale University School of Medicine — New Haven, Connecticut, United States
- VACT Healthcare System — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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