Pilot Test of a Community-based Buprenorphine Treatment Intervention

April 19, 2018 updated by: Chinazo Cunningham, Albert Einstein College of Medicine

Development of a Community-based Buprenorphine Treatment Intervention

The main goal of this study is to pilot test the community-based buprenorphine treatment (CBBT) intervention, examining buprenorphine treatment initiation, opioid use, and HIV risk behaviors. Two groups of participants will be followed for 60 days, with 3 research visits. One group will be enrolled prior to the CBBT intervention (pre-intervention), and one group after the CBBT intervention (post-intervention). Data sources will include questionnaires, urine toxicology tests, and medical record data. Investigators hypothesize that compared to the participants in the pre-intervention group, participants in the post-intervention group will be more likely to initiate buprenorphine treatment, reduce opioid use, and reduce high-risk HIV risk behaviors.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10033
        • Washington Heights CORNER Project

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • at least 18 years old
  • English or Spanish fluency
  • ever injected drugs
  • not receiving buprenorphine treatment (no prescribed buprenorphine in the previous 6 months)
  • clients of our collaborating community-based organization
  • interested in buprenorphine treatment

Exclusion Criteria:

  • pregnant
  • taking more than 60mg of methadone daily in the previous 30 days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-intervention
Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention.
Experimental: Post-intervention
Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention
Behavioral: Community-based buprenorphine treatment (CBBT) intervention
Community-based buprenorphine treatment (CBBT) intervention consists of three components which are delivered to staff of syringe exchange programs, including: 1) providing buprenorphine education, 2) facilitating access to buprenorphine treatment, and 3) providing support to individuals who initiate buprenorphine treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
initiation of buprenorphine treatment
Time Frame: 60 days
Medical record information will be extracted to determine initiation of buprenorphine treatment, which will be defined as a visit with a medical provider in which buprenorphine is prescribed.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
opioid use
Time Frame: 60 days
Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).
60 days

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HIV risk behaviors
Time Frame: 60 days
Drug- and sex-related HIV risk behaviors will be assessed using a standardized risk assessment tool used in NIDA's Clinical Trials Network.
60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Albert Einstein College of Medicine

Collaborators

National Institute on Drug Abuse (NIDA)
The City University of New York
Washington Heights Corner Project

Investigators

  • Principal Investigator: Chinazo Cunningham, MD, MS, Albert Einstein College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

January 2, 2013

First Submitted That Met QC Criteria

January 2, 2013

First Posted (Estimate)

January 4, 2013

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2012-381
  • R34DA031066 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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