This trial is active, not recruiting.

Condition reduction in heavy drinking in patients with hiv
Treatments naltrexone, placebo + medication management/medication coaching
Phase phase 2/phase 3
Sponsor Yale University
Collaborator National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Start date April 2011
End date August 2017
Trial size 154 participants
Trial identifier NCT01227044, 1R01AA018923, HIC0909005730


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
Naltrexone + Medical Management/Medication Coaching
naltrexone Vivitrol
NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
(Placebo Comparator)
Placebo plus Medical Management/Medication Coaching
placebo + medication management/medication coaching
Placebo + Medication Management/Medication Coaching

Primary Outcomes

To compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART.
time frame: One year

Secondary Outcomes

To compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking.
time frame: One year

Eligibility Criteria

Male or female participants at least 18 years old.

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).

Additional Information

Official title Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Principal investigator Lynn E Sullivan (Fiellin), MD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Yale University.