Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075

• Status: Completed
• Trial end date: 2019-06-27
• Target enrollment: 0
• Participant gender: All

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 inform the development of a future multi-site randomized clinical trial.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Duke University
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC; The EMMES Corporation
• Treatments: Analgesics, Opioid; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.