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Pilot Test of a Community-based Buprenorphine Treatment Intervention

This study is currently recruiting participants.
Verified January 2013 by Albert Einstein College of Medicine of Yeshiva University
Sponsor:
Collaborators:
National Institute on Drug Abuse (NIDA)
The City University of New York
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: NA
Last verified: January 2013
History: No changes posted
  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:

MedlinePlus related topics: HIV/AIDS
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.


Estimated Enrollment: 80
Study Start Date: December 2012
Estimated Study Completion Date: February 2014
Estimated 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
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01761110

Contacts
Contact: Chinazo Cunningham, MD.MS 718-944-3860 ccunning@montefiore.org
Contact: Mia Brisbane, MPH 718-944-3840 mbrisban@montefiore.org

Locations
United States, New York
Washington Heights Corner Project Recruiting
New York, New York, United States, 10033
Contact: Taeko Frost, MPH     212-923-7600        
Principal Investigator: Taeko Frost, MPH            
Sponsors and Collaborators
Albert Einstein College of Medicine of Yeshiva University
National Institute on Drug Abuse (NIDA)
The City University of New York
Washington Heights Corner Project
Investigators
Principal Investigator: Chinazo Cunningham, MD, MS Albert Einstein College of Medicine of Yeshiva University
  More Information

No publications provided

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: January 2, 2013
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
Mental Disorders
Buprenorphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
 Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotic Antagonists
Narcotics

ClinicalTrials.gov processed this record on June 18, 2013