Status:
COMPLETED
Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This pilot study examines the feasibility and acceptability of transitioning office-based buprenorphine treatment of opioid use disorder from physicians to pharmacists. Results from this study will in...
Detailed Description
The overall objective of this study is to explore the feasibility of transitioning the care of adult patients with opioid use disorder (OUD) who receive office-based buprenorphine treatment (OBBT) fro...
Eligibility Criteria
Inclusion
- Be adults aged 18 years or older.
- If female, use adequate birth control methods.
- Meet DSM-5 criteria for past-year OUD and have completed buprenorphine induction for OUD.
- Have expressed the intention to receive maintenance (≥6 months) buprenorphine treatment.
- Be willing to receive pharmacist administered buprenorphine maintenance treatment
- Be willing and able to provide written informed consent and HIPAA authorization.
- Be able to read and communicate in English.
- Be able to comply with buprenorphine treatment policies.
Exclusion
- Have a serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, compromise study findings, or prevent the participant from completing the study.
- Have known allergy or hypersensitivity to buprenorphine, naloxone, or other components of the buprenorphine/naloxone formulation.
- Have aspartate aminotransferase (AST) or alanine aminotransferase (ALT) liver enzymes greater than 5 times the upper limit of normal on screening phlebotomy performed within 60 days prior to the date of the last stabilization visit.
- Have chronic pain requiring ongoing pain management with opioid analgesics.
- Pending legal action or other reasons that might prevent an individual from completing the study (i.e., unable to complete 6 months of pharmacy-based OUD management).
- Pregnant or breastfeeding at the time of screening.
Key Trial Info
Start Date :
March 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 27 2019
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT03248947
Start Date
March 28 2018
End Date
June 27 2019
Last Update
July 28 2021
Active Locations (6)
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1
Duke Outpatient Clinic
Durham, North Carolina, United States, 27704
2
Josefs Pharmacy
Durham, North Carolina, United States, 27704
3
Changes by Choice
Durham, North Carolina, United States, 27705
4
Clinic Pharmacy
Durham, North Carolina, United States, 27705