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

October 20, 2010
July 8, 2014
April 2011
November 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01227044 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Reduction in Heavy Drinking in Patients With HIV
  • 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
  • Other: Placebo + Medication Management/Medication Coaching
    Placebo + Medication Management/Medication Coaching
  • Active Comparator: NTX + MM/MC
    Naltrexone + Medical Management/Medication Coaching
    Intervention: Drug: Naltrexone
  • Placebo Comparator: Placebo + MM/MC
    Placebo plus Medical Management/Medication Coaching
    Intervention: Other: Placebo + Medication Management/Medication Coaching
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
154
November 2015
November 2014   (final data collection date for primary outcome measure)

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).

    -

Both
18 Years and older
No
Contact: Cheryl M Danton, MHS 203-737-3347 cheryl.danton@yale.edu
Contact: Sarah Caffrey, M.S. 203-314-3674 scaffrey@aptfoundation.org
United States
 
NCT01227044
HIC0909005730, 1RO1AA018923
Yes
Lynn E. Fiellin, Yale University
Yale University
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Principal Investigator: Lynn E Sullivan (Fiellin), MD Yale University
Yale University
July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP