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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 : February 2, 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.

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Opioid Dependence Injection Drug Use Behavioral: Community-based buprenorphine treatment (CBBT) intervention Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 77 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Development of a Community-based Buprenorphine Treatment Intervention
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/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
 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.


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).


Other Outcome Measures:
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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, Inc.
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, Inc.
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Chinazo Cunningham, Professor, Albert Einstein College of Medicine, Inc.
ClinicalTrials.gov Identifier: NCT01761110     History of Changes
Other Study ID Numbers: R34DA031066 ( U.S. NIH Grant/Contract )
First Posted: January 4, 2013    Key Record Dates
Last Update Posted: February 2, 2018
Last Verified: January 2018

Keywords provided by Chinazo Cunningham, Albert Einstein College of Medicine, Inc.:
Opioid dependence
Injection drug use
Buprenorphine
Opioid agonist treatment
 Access to care
HIV risk behaviors
Opioids

Additional relevant MeSH terms:
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
 Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists