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

Primary Purpose

Reduction in Heavy Drinking in Patients With HIV

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naltrexone
Placebo + Medication Management/Medication Coaching
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Reduction in Heavy Drinking in Patients With HIV focused on measuring Substance Abuse Counseling, Adherence (medication), Alcohol Abuse, Highly Active Antiretroviral Therapy (HAART), Naltrexone, Vivitrol, HIV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

    -

Sites / Locations

  • Yale University School of Medicine
  • VACT Healthcare System

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

NTX + MM/MC

Placebo + MM/MC

Arm Description

Naltrexone + Medical Management/Medication Coaching

Placebo plus Medical Management/Medication Coaching

Outcomes

Primary Outcome Measures

HAART Adherence
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 Outcome Measures

Heavy Drinking Days
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.

Full Information

First Posted
October 20, 2010
Last Updated
March 20, 2019
Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
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1. Study Identification

Unique Protocol Identification Number
NCT01227044
Brief Title
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Acronym
DAWN
Official Title
Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute on Alcohol Abuse and Alcoholism (NIAAA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reduction in Heavy Drinking in Patients With HIV
Keywords
Substance Abuse Counseling, Adherence (medication), Alcohol Abuse, Highly Active Antiretroviral Therapy (HAART), Naltrexone, Vivitrol, HIV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
51 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NTX + MM/MC
Arm Type
Active Comparator
Arm Description
Naltrexone + Medical Management/Medication Coaching
Arm Title
Placebo + MM/MC
Arm Type
Placebo Comparator
Arm Description
Placebo plus Medical Management/Medication Coaching
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
Vivitrol
Intervention Description
NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
Intervention Type
Other
Intervention Name(s)
Placebo + Medication Management/Medication Coaching
Intervention Description
Placebo + Medication Management/Medication Coaching
Primary Outcome Measure Information:
Title
HAART Adherence
Description
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.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Heavy Drinking Days
Description
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.
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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). -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lynn E Sullivan (Fiellin), MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
VACT Healthcare System
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30073637
Citation
Edelman EJ, Moore BA, Holt SR, Hansen N, Kyriakides TC, Virata M, Brown ST, Justice AC, Bryant KJ, Fiellin DA, Fiellin LE. Efficacy of Extended-Release Naltrexone on HIV-Related and Drinking Outcomes Among HIV-Positive Patients: A Randomized-Controlled Trial. AIDS Behav. 2019 Jan;23(1):211-221. doi: 10.1007/s10461-018-2241-z.
Results Reference
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Reducing Heavy Drinking to Optimize HIV/AIDS Treatment and Prevention

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