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OpenTrials
Completed

NCT Number: NCT00622596

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

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.

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Key information

Conditions

Opiate Dependence Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06510, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mobile Access

Other

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 outcomes

  1. Attendance

    Time frame: 10/1/03-9/30/08

    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.

  2. Opioid free urine toxicology

    Time frame: 10/1/03-9/30/08

    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 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.

    Time frame: 10/1/03-9/30/08

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Acronym: Project BEST

Important dates

Study start
2003
Primary completion
2008
Study completion
2008
First posted
Feb 25, 2008
Registry last updated
Aug 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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