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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00622596
Other study ID # 0504027630
Secondary ID
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


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
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