Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

Opiate Dependence Clinical Trial

— Project BEST  

Official title:

Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00622596
• Other study ID #: 0504027630
• Status: Completed
• Phase: N/A
• First received: February 13, 2008
• Last updated: August 23, 2016
• Start date: October 2003
• Est. completion date: September 2008

Study information

• Verified date: August 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opiate Dependence
• Opioid-Related Disorders

Intervention

Other:
• Mobile Access
Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	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	No