Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention (DAWN)

Yale University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Reduction in Heavy Drinking in Patients With HIV

Treatments: Drug: Naltrexone; Other: Placebo + Medication Management/Medication Coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01227044

1R01AA018923 (U.S. NIH Grant/Contract)

0909005730

Details and patient eligibility

About

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.

Enrollment: 51 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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51 participants in 2 patient groups, including a placebo group

NTX + MM/MC

Active Comparator group

Description:

Naltrexone + Medical Management/Medication Coaching

Treatment:

Drug: Naltrexone

Placebo + MM/MC

Placebo Comparator group

Description:

Placebo plus Medical Management/Medication Coaching

Treatment:

Other: Placebo + Medication Management/Medication Coaching