Pilot Test of a Community-based Buprenorphine Treatment Intervention

This study has been completed.

Sponsor:

Collaborators:

National Institute on Drug Abuse (NIDA)

City University of New York, School of Public Health

Washington Heights Corner Project

Information provided by (Responsible Party):

Albert Einstein College of Medicine of Yeshiva University

ClinicalTrials.gov Identifier:

NCT01761110

First received: January 2, 2013

Last updated: June 24, 2015

Last verified: June 2015

History of Changes

Purpose

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. We 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.

Condition	Intervention
Opioid Dependence Injection Drug Use	Behavioral: Community-based buprenorphine treatment (CBBT) intervention


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Development of a Community-based Buprenorphine Treatment Intervention

Resource links provided by NLM:

Drug Information available for: Buprenorphine Buprenorphine hydrochloride

U.S. FDA Resources

Further study details as provided by Albert Einstein College of Medicine of Yeshiva University:

Primary Outcome Measures:

initiation of buprenorphine treatment [ Time Frame: 60 days ] [ Designated as safety issue: No ]
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 [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).

Other Outcome Measures:

HIV risk behaviors [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Drug- and sex-related HIV risk behaviors will be assessed using a standardized risk assessment tool used in NIDA's Clinical Trials Network.


Enrollment:	77
Study Start Date:	December 2012
Study Completion Date:	February 2014
Primary Completion Date:	February 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761110

Locations


United States, New York
Washington Heights Corner Project
New York, New York, United States, 10033

Sponsors and Collaborators

Albert Einstein College of Medicine of Yeshiva University

National Institute on Drug Abuse (NIDA)

City University of New York, School of Public Health

Washington Heights Corner Project

Investigators


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

More Information


Responsible Party:	Albert Einstein College of Medicine of Yeshiva University
ClinicalTrials.gov Identifier:	NCT01761110 History of Changes
Other Study ID Numbers:	R34DA031066
Study First Received:	January 2, 2013
Last Updated:	June 24, 2015
Health Authority:	United States: Institutional Review Board

Keywords provided by Albert Einstein College of Medicine of Yeshiva University:


Opioid dependence Injection drug use Buprenorphine Opioid agonist treatment	Access to care HIV risk behaviors Opioids

Additional relevant MeSH terms:


Opioid-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Buprenorphine Analgesics, Opioid Narcotics	Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists

ClinicalTrials.gov processed this record on September 30, 2016

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