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

Arm | Intervention/treatment |
---|---|
No Intervention: Pre-intervention
Participants will be enrolled prior to the implementation of the community-based buprenorphine treatment (CBBT) intervention.
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Experimental: Post-intervention
Participants will be enrolled after implementing the community-based buprenorphine treatment (CBBT) intervention
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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.
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- 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.
- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

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
United States, New York | |
Washington Heights Corner Project | |
New York, New York, United States, 10033 |
Principal Investigator: | Chinazo Cunningham, MD, MS | Albert Einstein College of Medicine, Inc. |
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 |