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Pilot Test of a Community-based Buprenorphine Treatment Intervention

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ClinicalTrials.gov Identifier: NCT01761110
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The City University of New York
Washington Heights Corner Project
Information provided by (Responsible Party):
Chinazo Cunningham, Albert Einstein College of Medicine, Inc.

January 2, 2013
January 4, 2013
April 23, 2018
December 2012
February 2014   (Final data collection date for primary outcome measure)
initiation of buprenorphine treatment [ Time Frame: 60 days ]
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.
Same as current
Complete list of historical versions of study NCT01761110 on ClinicalTrials.gov Archive Site
opioid use [ Time Frame: 60 days ]
Opioid use will be determined via self-report using the Addiction Severity Index and via urine specimens (e.g., urine toxicology testing).
Same as current
HIV risk behaviors [ Time Frame: 60 days ]
Drug- and sex-related HIV risk behaviors will be assessed using a standardized risk assessment tool used in NIDA's Clinical Trials Network.
Same as current
 
Pilot Test of a Community-based Buprenorphine Treatment Intervention
Development of a Community-based Buprenorphine Treatment Intervention
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Opioid Dependence
  • Injection Drug Use
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.
  • 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
    Intervention: Behavioral: Community-based buprenorphine treatment (CBBT) intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
77
80
February 2014
February 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01761110
2012-381
R34DA031066 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Chinazo Cunningham, Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
  • National Institute on Drug Abuse (NIDA)
  • The City University of New York
  • Washington Heights Corner Project
Principal Investigator: Chinazo Cunningham, MD, MS Albert Einstein College of Medicine, Inc.
Albert Einstein College of Medicine, Inc.
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP