Pilot Test of a Community-based Buprenorphine Treatment Intervention

NCT ID: NCT01761110

Last Updated: 2018-04-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2014-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Opioid Dependence Injection Drug Use

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-intervention

Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Post-intervention

Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention

Group Type EXPERIMENTAL

Community-based buprenorphine treatment (CBBT) intervention

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

City University of New York

OTHER

Sponsor Role collaborator

Washington Heights Corner Project

UNKNOWN

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Chinazo Cunningham

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chinazo Cunningham, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Washington Heights Corner Project

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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R34DA031066

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2012-381

Identifier Type: -

Identifier Source: org_study_id

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