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

This study has been completed.
Information provided by:
Yale University Identifier:
First received: February 13, 2008
Last updated: June 30, 2011
Last verified: June 2011

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: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

Resource links provided by NLM:

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 ]

Enrollment: 200
Study Start Date: October 2003
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: buprenorphine
Day 1: 8 mg of buprenorphine, then Day 2 on: 16 mg daily of buprenorphine sublingually


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

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
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Please refer to this study by its identifier: NCT00622596

United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Yale University
Principal Investigator: Frederick L Altice, MD Yale University School of Medicine/AIDS Program
  More Information

No publications provided

Responsible Party: Frederick L. Altice, MD, Yale University AIDS Program Identifier: NCT00622596     History of Changes
Other Study ID Numbers: 0504027630
Study First Received: February 13, 2008
Last Updated: June 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
opiate dependence

Additional relevant MeSH terms:
Opioid-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Analgesics, Opioid
Central Nervous System Agents
Central Nervous System Depressants
Narcotic Antagonists
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses processed this record on November 24, 2014