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

Early Phase 1

Completed

Interventions: Drug: buprenorphine/naloxone
Other: Pharmacist-administered buprenorphine/naloxone maintenance care

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Pharmacy opioid use disorder care	Pharmacist-administered buprenorphine/naloxone maintenance care	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.
Pharmacy opioid use disorder care	buprenorphine/naloxone	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.

Primary Outcome Measures

Name	Time	Method
Recruitment Rate	Up to six months	Measured by a composite of the number of participants with opioid use disorder recruited (i.e., signed the informed consent form) per month, and by site and the average monthly rate of participants enrolled among potential participants who were screened.
Treatment Retention	Up to six months	Number of scheduled visits completed.
Number of Participants With Opioid and Other Substance Use	Up to six months	Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.
Number of Medication-Compliant Months Across All Participants	Up to six months	Medication compliance is defined as taking any of the dispensed medication during the past month as measured by pill count/dose reconciliation at each study visit. Medication compliance is calculated as the percentage of compliant months out of the overall number of expected study months.

Secondary Outcome Measures

Name	Time	Method
Treatment Fidelity	Up to six months	Number of monitored study visits with physicians and pharmacists showing 80% adherence or higher to study specific tasks and responsibilities. Adherence will be calculated as the number of items completed on the Buprenorphine Visit Checklist divided by the sum of the number of complete and incomplete items.
Treatment Satisfaction	Up to six months	Indicators of satisfaction with treatment delivery measured by participants, pharmacists, and physicians using the Treatment Satisfaction Scale after each study visit. A score of 5=very satisfied, 4=satisfied, 3=neither satisfied or dissatisfied, 2=dissatisfied, and 1=very dissatisfied.
Participant Safety	Up to six months	A composite of self-report and medical record abstraction to measure any fatal or non-fatal opioid overdose and any opioid or other substance-related emergency department visit or hospitalization.
Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)	Up to six months	Measured at each study visit via an action item checklist to confirm whether the PDMP was inquired to identify the following for each participant: measures of multiple buprenorphine prescriptions, any prescriptions for class II and III medications, and any other information that may be useful for the participant's treatment such as documented drug-related medical interventions or disciplinary charges.

Locations (6): Carolina Performance
🇺🇸
Raleigh, North Carolina, United States
Clinic Pharmacy
🇺🇸
Durham, North Carolina, United States
Duke Outpatient Clinic
🇺🇸
Durham, North Carolina, United States
Josefs Pharmacy
🇺🇸
Durham, North Carolina, United States
Changes by Choice
🇺🇸
Durham, North Carolina, United States
Health Park Pharmacy
🇺🇸
Raleigh, North Carolina, United States