Pilot Test of a Community-based Buprenorphine Treatment Intervention
Primary Purpose
Opioid Dependence, Injection Drug Use
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community-based buprenorphine treatment (CBBT) intervention
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Dependence focused on measuring Opioid dependence, Injection drug use, Buprenorphine, Opioid agonist treatment, Access to care, HIV risk behaviors, Opioids
Eligibility Criteria
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
Sites / Locations
- Washington Heights Corner Project
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Pre-intervention
Post-intervention
Arm Description
Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention.
Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention
Outcomes
Primary Outcome Measures
initiation of buprenorphine treatment
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.
Secondary Outcome Measures
opioid use
Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).
Full Information
NCT ID
NCT01761110
First Posted
January 2, 2013
Last Updated
April 19, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Drug Abuse (NIDA), The City University of New York, Washington Heights Corner Project
1. Study Identification
Unique Protocol Identification Number
NCT01761110
Brief Title
Pilot Test of a Community-based Buprenorphine Treatment Intervention
Official Title
Development of a Community-based Buprenorphine Treatment Intervention
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
National Institute on Drug Abuse (NIDA), The City University of New York, Washington Heights Corner Project
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Dependence, Injection Drug Use
Keywords
Opioid dependence, Injection drug use, Buprenorphine, Opioid agonist treatment, Access to care, HIV risk behaviors, Opioids
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pre-intervention
Arm Type
No Intervention
Arm Description
Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention.
Arm Title
Post-intervention
Arm Type
Experimental
Arm Description
Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention
Intervention Type
Behavioral
Intervention Name(s)
Community-based buprenorphine treatment (CBBT) intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
initiation of buprenorphine treatment
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
opioid use
Description
Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).
Time Frame
60 days
Other Pre-specified Outcome Measures:
Title
HIV risk behaviors
Description
Drug- and sex-related HIV risk behaviors will be assessed using a standardized risk assessment tool used in NIDA's Clinical Trials Network.
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chinazo Cunningham, MD, MS
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington Heights Corner Project
City
New York
State/Province
New York
ZIP/Postal Code
10033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Test of a Community-based Buprenorphine Treatment Intervention
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