Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
| Status: | Completed |
|---|---|
| Conditions: | HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/23/2019 |
| Start Date: | April 2011 |
| End Date: | August 2017 |
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.
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.
Inclusion Criteria:
1. Be HIV-infected.
2. Currently be prescribed HAART medication or be eligible to receive HAART medication.
3. Report less than 95% adherence to their HAART medication.
4. 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.
5. Be at least 18 years old.
6. Be able to understand English and provide informed consent.
Exclusion Criteria:
1. Be psychotic or severely psychiatrically disabled.
2. Be currently enrolled in formal treatment for alcohol (excluding self-help, e.g.
Alcoholics Anonymous)
3. Have medical conditions that would preclude completing or be of harm during the course
of the study.
4. 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.
5. Have a known contraindication to NTX therapy (e.g. requiring opioid medication for
pain).
6. Be pregnant, nursing or unable to use an effective method of birth control (women).
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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