Clinical trial NCT03248947: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075
Official title: Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: Clinical Trials Network 0075
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Opioid Use Disorder
Keywords: opioid use disorder
Medication-assisted treatment
Buprenorphine treatment
Collaborative care model
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2017-08-15
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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) 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.

Eligibility 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.

Primary outcomes:
measure: Recruitment Rate
timeFrame: Up to six months
measure: Treatment Retention
timeFrame: Up to six months
measure: Number of Participants With Opioid and Other Substance Use
timeFrame: Up to six months
measure: Number of Medication-Compliant Months Across All Participants
timeFrame: Up to six months
Secondary outcomes:
measure: Treatment Fidelity
timeFrame: Up to six months
measure: Treatment Satisfaction
timeFrame: Up to six months
measure: Participant Safety
timeFrame: Up to six months
measure: Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)
timeFrame: Up to six months
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Outpatient Clinic
state: North Carolina
city: Durham
country: United States
facility: Josefs Pharmacy
state: North Carolina
city: Durham
country: United States
facility: Changes by Choice
state: North Carolina
city: Durham
country: United States
facility: Clinic Pharmacy
state: North Carolina
city: Raleigh
country: United States
facility: Carolina Performance
state: North Carolina
city: Raleigh
country: United States
facility: Health Park Pharmacy
state: North Carolina
Study officials:
affiliation: Professor
name: Li-Tzy Wu, Sc.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor
name: Paolo Mannelli, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu LT, John WS, Ghitza UE, Wahle A, Matthews AG, Lewis M, Hart B, Hubbard Z, Bowlby LA, Greenblatt LH, Mannelli P; Pharm-OUD-Care Collaborative Investigators. Buprenorphine physician-pharmacist collaboration in the management of patients with opioid use disorder: results from a multisite study of the National Drug Abuse Treatment Clinical Trials Network. Addiction. 2021 Jul;116(7):1805-1816. doi: 10.1111/add.15353. Epub 2021 Jan 11.