Phase 3
Completed N=51
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Reduction in Heavy Drinking in Patients With HIV
Source: ClinicalTrials.gov NCT01227044 ↗
Enrolled (actual)
51
Serious AEs
17.7%
Results posted
Mar 2019
Primary outcomePrimary: HAART Adherence — 7; 4; 6; 4 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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-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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY HAART Adherence |
7; 4; 6; 4; 8; 4 | — |
| SECONDARY Heavy Drinking Days |
8.4; 1.7; 5.4; 0.1; 4.2; 0.5 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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).
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Data sourced from ClinicalTrials.gov (NCT01227044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.