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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Yale University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lynn E. Fiellin, Yale University
ClinicalTrials.gov Identifier:
NCT01227044
First received: October 20, 2010
Last updated: July 8, 2014
Last verified: July 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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: November 2015
Estimated Primary Completion Date: November 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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).

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01227044

Contacts
Contact: Cheryl M Danton, MHS 203-737-3347 cheryl.danton@yale.edu
Contact: Sarah Caffrey, M.S. 203-314-3674 scaffrey@aptfoundation.org

Locations
United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Contact: Cheryl M Danton, MHS    203-737-3347    cheryl.danton@yale.edu   
VACT Healthcare System Recruiting
New Haven, Connecticut, United States, 06516
Contact: Sarah Caffrey, MS    203-314-3674    scaffrey@aptfoundation.org   
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Lynn E Sullivan (Fiellin), MD Yale University
  More Information

No publications provided

Responsible Party: Lynn E. Fiellin, Associate Professor, Yale University
ClinicalTrials.gov Identifier: NCT01227044     History of Changes
Other Study ID Numbers: HIC0909005730, 1RO1AA018923
Study First Received: October 20, 2010
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by 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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 28, 2014