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

This study has been completed.
Sponsor:
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00622596
First received: February 13, 2008
Last updated: June 30, 2011
Last verified: June 2011
History of Changes
  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: 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:

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 ]

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

  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

Locations
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
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: Frederick L. Altice, MD, Yale University AIDS Program
ClinicalTrials.gov 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
buprenorphine

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Mental Disorders
Buprenorphine
Naloxone
Analgesics, Opioid
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013