Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
Project BEST
1 other identifier
interventional
200
1 country
1
Brief Summary
The purpose of this study was to expand access to buprenorphine using a mobile health care system among marginalized populations with or at high risk for HIV and observe longitudinal effects of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2003
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2003
CompletedFirst Submitted
Initial submission to the registry
February 13, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2008
CompletedAugust 24, 2016
August 1, 2016
4.9 years
February 13, 2008
August 23, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Attendance
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 tracked attendance.
10/1/03-9/30/08
Opioid free urine toxicology
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 incidence of opioid free urine toxicology.
10/1/03-9/30/08
Secondary Outcomes (1)
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.
10/1/03-9/30/08
Study Arms (1)
Mobile Access to Buprenorphine
EXPERIMENTALHigh risk populations accessing a mobile health care system can obtain Buprenorphine for treatment.
Interventions
Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.
Eligibility Criteria
You may qualify if:
- HIV +
- At high risk for HIV (IV drug use, commercial sex worker, partner of HIV+)
- Mental Health (unmanaged or diagnosed mental illness)
You may not qualify if:
- Benzodiazepine use
- Opiate use due to pain management issues only (present or past)
- Non-IDU
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University School of Medicine
New Haven, Connecticut, 06510, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frederick L Altice, MD
Yale University School of Medicine/AIDS Program
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 13, 2008
First Posted
February 25, 2008
Study Start
October 1, 2003
Primary Completion
September 1, 2008
Study Completion
September 1, 2008
Last Updated
August 24, 2016
Record last verified: 2016-08
Data Sharing
- IPD Sharing
- Will not share