NCT01761110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 2, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

April 23, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

January 2, 2013

Last Update Submit

April 19, 2018

Conditions

Opioid DependenceInjection Drug Use

Keywords

Opioid dependenceInjection drug useBuprenorphineOpioid agonist treatmentAccess to careHIV risk behaviorsOpioids

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • opioid use

    60 days

Other Outcomes (1)

  • HIV risk behaviors

    60 days

Study Arms (2)

Pre-intervention

NO INTERVENTION

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

Post-intervention

EXPERIMENTAL

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

Behavioral: Community-based buprenorphine treatment (CBBT) intervention

Interventions

Community-based buprenorphine treatment (CBBT) interventionBEHAVIORAL

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.

Post-intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington Heights Corner Project

New York, New York, 10033, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Methods

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Chinazo Cunningham, MD, MS

    Albert Einstein College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 2, 2013

First Posted

January 4, 2013

Study Start

December 1, 2012

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

April 23, 2018

Record last verified: 2018-04

Locations

US(1)