Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 (Pharm-OUD-Care)

Duke University

Status and phase: Completed; Early Phase 1

Conditions: Opioid Use Disorder

Treatments: Other: Pharmacist-administered buprenorphine/naloxone maintenance care; Drug: buprenorphine/naloxone

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT03248947

UG1DA040317 (U.S. NIH Grant/Contract)

Pro00083544

Details and patient eligibility

About

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.

Full 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) from physicians to pharmacists. Physicians will induce buprenorphine treatment and complete the stabilization phase before referring patients to pharmacists for the management of monthly maintenance visits. This study will assess the feasibility and acceptability of a collaborative care model between physician and pharmacist by measuring recruitment rate, treatment retention rate, treatment compliance rate, and participants' substance use. Other assessments measured will include treatment fidelity, participant, physician, and pharmacist satisfaction with OUD care, participant safety, and the pharmacists' use of electronic health records and the Prescription Drug Monitoring Program.

Enrollment: 71 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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71 participants in 1 patient group

Pharmacy opioid use disorder care

Other group

Description:

A single-arm study to evaluate the feasibility and acceptability of transitioning office-based buprenorphine treatment of adult patients with opioid use disorder from physicians to pharmacists.

Treatment:

Other: Pharmacist-administered buprenorphine/naloxone maintenance care

Drug: buprenorphine/naloxone