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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01227044
First Posted: October 22, 2010
Last Update Posted: September 30, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Information provided by (Responsible Party):
Lynn E. Fiellin, Yale University
  Purpose
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.

Condition Intervention Phase
Reduction in Heavy Drinking in Patients With HIV Drug: Naltrexone Other: Placebo + Medication Management/Medication Coaching Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Resource links provided by NLM:

MedlinePlus related topics: HIV/AIDS
Drug Information available for: Naltrexone Naltrexone hydrochloride
U.S. FDA Resources

Further study details as provided by Lynn E. Fiellin, Yale University:

Primary Outcome Measures:
  • To compare the efficacy of NTX +MM/MC versus placebo +MM/MC on adherence to HAART. [ Time Frame: One year ]
    NTX +MM/MC will lead to improved adherence to HAART when compared to placebo + MM/MC.


Secondary Outcome Measures:
  • To compare the efficacy of NTX +MM/MC versus placebo +MM/MC in reducing days of heavy drinking. [ Time Frame: One year ]
    NTX +MM/MC will lead to greater reductions in the number of days of heavy drinking when compared to placebo + MM/MC.
Estimated Enrollment: 154
Study Start Date: April 2011
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: NTX + MM/MC
Naltrexone + Medical Management/Medication Coaching
 Drug: Naltrexone
NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
Other Name: Vivitrol
Placebo Comparator: Placebo + MM/MC
Placebo plus Medical Management/Medication Coaching
 Other: Placebo + Medication Management/Medication Coaching
Placebo + Medication Management/Medication Coaching

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01227044


Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
VACT Healthcare System
New Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Investigators
Principal Investigator: Lynn E Sullivan (Fiellin), MD Yale University
  More Information

Responsible Party: Lynn E. Fiellin, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01227044     History of Changes
Other Study ID Numbers: HIC0909005730
1R01AA018923 ( U.S. NIH Grant/Contract )
First Submitted: October 20, 2010
First Posted: October 22, 2010
Last Update Posted: September 30, 2016
Last Verified: January 2016

Keywords provided by Lynn E. Fiellin, Yale University:
Substance Abuse Counseling
Adherence (medication)
Alcohol Abuse
Highly Active Antiretroviral Therapy (HAART)
 Naltrexone
Vivitrol
HIV

Additional relevant MeSH terms:
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents


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