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OpenTrials
Completed

NCT Number: NCT01227044

Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

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.

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Key information

Conditions

Reduction in Heavy Drinking in Patients With HIV Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Health Behavior Medication Adherence Mental Disorders Patient Acceptance of Health Care Patient Compliance Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

VACT Healthcare System, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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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Treatment and study plan

Naltrexone

Drug

NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.

Other names: Vivitrol

Placebo + Medication Management/Medication Coaching

Other

Placebo + Medication Management/Medication Coaching

Primary outcomes

  1. HAART Adherence

    Time frame: One year

    The intent of this outcome is to compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. It is hypothesized that NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.

Secondary outcomes

  1. Heavy Drinking Days

    Time frame: One year

    This outcome is intended to compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. It is hypothesized that NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Registry information

Acronym: DAWN

Important dates

Study start
2011
Primary completion
2017
Study completion
2017
First posted
Oct 22, 2010
Registry last updated
Mar 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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