Pilot Test of a Community-based Buprenorphine Treatment Intervention

Opioid Dependence Clinical Trial

Official title:

Development of a Community-based Buprenorphine Treatment Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761110
• Other study ID #: 2012-381
• Secondary ID: R34DA031066
• Status: Completed
• Phase: N/A
• First received: January 2, 2013
• Last updated: April 19, 2018
• Start date: December 2012
• Est. completion date: February 2014

Study information

• Verified date: April 2018
• Source: Albert Einstein College of Medicine, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Injection Drug Use
• Opioid Dependence

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.

Locations

Country	Name	City	State
United States	Washington Heights Corner Project	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine, Inc.	National Institute on Drug Abuse (NIDA), The City University of New York, Washington Heights Corner Project

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	HIV risk behaviors	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
Primary	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.	60 days
Secondary	opioid use	Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).	60 days