Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance - Full Text View

Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance (Project BEST)

This study is currently recruiting participants.

Verified by Yale University, April 2008

First Received: February 13, 2008 Last Updated: April 21, 2008 History of Changes

Sponsored by:	Yale University
Information provided by:	Yale University
ClinicalTrials.gov Identifier:	NCT00622596

Purpose

To expand access to buprenorphine among marginalized populations with or at high risk for HIV and observe longitudinal effects of treatment. To assess the feasibility and efficacy of the use of buprenorphine to treat opioid dependence in these high risk populations.

Condition	Intervention
Opiate Dependence	Drug: buprenorphine

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment
Official Title:	Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride Naloxone

U.S. FDA Resources

Further study details as provided by Yale University:

Primary Outcome Measures:

To assess the feasibility and efficacy of the use of buprenorphine to treat opioid dependence in high risk populations accessing a mobile health care system using attendance and opioid free urine toxicology. [ Time Frame: 10/1/03-9/30/08 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Access to other health care, incarceration, hospitalization acceptability of the site of care from both patient and provider perspectives, and attendance and adherence to counseling. [ Time Frame: 10/1/03-9/30/08 ] [ Designated as safety issue: No ]

Estimated Enrollment:	200
Study Start Date:	October 2003
Estimated Study Completion Date:	October 2008
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: buprenorphine Day 1: 8 mg of buprenorphine, then Day 2 on: 16 mg daily of buprenorphine sublingually

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

HIV +
At high risk for HIV (IV drug use, commercial sex worker, partner of HIV+)
Mental Health (unmanaged or diagnosed mental illness)

Exclusion Criteria:

Benzodiazepine use
Opiate use due to pain management issues only (present or past)
Non-IDU

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00622596

Contacts

Contact: Mary R Walton, MHS, PA-C	203-314-9170	mary.walton@yale.edu
Contact: Doug Bruce, MD, MA	203-314-2860	robert.bruce@yale.edu

Locations

United States, Connecticut
Yale University School of Medicine	Recruiting
New Haven, Connecticut, United States, 06510
Contact: Mary R Walton, MHS, PA-C
Principal Investigator: Frederick L Altice, MD

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:

Frederick L Altice, MD

Yale University School of Medicine/AIDS Program

More Information

No publications provided

Responsible Party:	Yale University AIDS Program ( Frederick L. Altice, MD )
Study ID Numbers:	0504027630
Study First Received:	February 13, 2008
Last Updated:	April 21, 2008
ClinicalTrials.gov Identifier:	NCT00622596 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Yale University:

opiate dependence
buprenorphine

Study placed in the following topic categories:

Buprenorphine
Mental Disorders
Narcotic Antagonists
Substance-Related Disorders
Central Nervous System Depressants
Disorders of Environmental Origin

Narcotics
Peripheral Nervous System Agents
Analgesics
Opioid-Related Disorders
Analgesics, Opioid
Naloxone

Additional relevant MeSH terms:

Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Disorders of Environmental Origin
Narcotics
Opioid-Related Disorders
Pharmacologic Actions
Buprenorphine

Mental Disorders
Sensory System Agents
Therapeutic Uses
Substance-Related Disorders
Analgesics
Peripheral Nervous System Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on September 03, 2009