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

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Yale University

Sponsor:

Collaborator:

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Information provided by (Responsible Party):

Lynn E. Fiellin, Yale University

ClinicalTrials.gov Identifier:

NCT01227044

First received: October 20, 2010

Last updated: February 19, 2015

Last verified: February 2015

History of Changes

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:

MedlinePlus related topics: HIV/AIDS

Drug Information available for: Naltrexone Naltrexone hydrochloride

U.S. FDA Resources

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 2015 (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:

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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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: Orli Florsheim, BA	203-314-3674	orli.florsheim@yale.edu

Locations


United States, Connecticut
VACT Healthcare System	Recruiting
New Haven, Connecticut, United States, 06516
Contact: Cheryl Danton, MHS 203-737-3347 cheryl.danton@yale.edu
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Cheryl M Danton, MHS 203-737-3347 cheryl.danton@yale.edu

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

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:	February 19, 2015
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 Central Nervous System Agents Narcotic Antagonists Peripheral Nervous System Agents	Pharmacologic Actions Physiological Effects of Drugs Sensory System Agents Therapeutic Uses

ClinicalTrials.gov processed this record on March 01, 2015

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