Back to resultsProspective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance (Project BEST)
Primary Purpose
Opiate Dependence
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Access
Sponsored by
About this trial
This is an interventional treatment trial for Opiate Dependence focused on measuring opiate dependence, buprenorphine
Eligibility 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
Sites / Locations
- Yale University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mobile Access to Buprenorphine
Arm Description
High risk populations accessing a mobile health care system can obtain Buprenorphine for treatment.
Outcomes
Primary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00622596
Brief Title
Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
Acronym
Project BEST
Official Title
Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opiate Dependence
Keywords
opiate dependence, buprenorphine
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mobile Access to Buprenorphine
Arm Type
Experimental
Arm Description
High risk populations accessing a mobile health care system can obtain Buprenorphine for treatment.
Intervention Type
Other
Intervention Name(s)
Mobile Access
Intervention Description
Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.
Primary Outcome Measure Information:
Title
Attendance
Description
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.
Time Frame
10/1/03-9/30/08
Title
Opioid free urine toxicology
Description
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.
Time Frame
10/1/03-9/30/08
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frederick L Altice, MD
Organizational Affiliation
Yale University School of Medicine/AIDS Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance
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