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

NCT ID: NCT03248947

Last Updated: 2021-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-28
• Study Completion Date: 2019-06-27

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.

Conditions

Opioid Use Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Pharmacy opioid use disorder 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.

Group Type: OTHER

buprenorphine/naloxone

Intervention Type: DRUG

To relieve opioid withdrawal symptoms and craving, buprenorphine/naloxone will be prescribed by the study-physician and dispensed by the study-pharmacist on a monthly basis. The median expected dose is 16 mg daily, though adjustment by the study physician may be needed due to increased withdrawal and craving from previous study visits. Medication will be provided in the form of a sublingual film.

Pharmacist-administered buprenorphine/naloxone maintenance care

Intervention Type: OTHER

Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.

Interventions

buprenorphine/naloxone

To relieve opioid withdrawal symptoms and craving, buprenorphine/naloxone will be prescribed by the study-physician and dispensed by the study-pharmacist on a monthly basis. The median expected dose is 16 mg daily, though adjustment by the study physician may be needed due to increased withdrawal and craving from previous study visits. Medication will be provided in the form of a sublingual film.

Intervention Type: DRUG

Pharmacist-administered buprenorphine/naloxone maintenance care

Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

The Emmes Company, LLC

INDUSTRY

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li-Tzy Wu, Sc.D.

Role: PRINCIPAL_INVESTIGATOR

Professor

Paolo Mannelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Locations

Duke Outpatient Clinic

Durham, North Carolina, United States

Josefs Pharmacy

Durham, North Carolina, United States

Changes by Choice

Durham, North Carolina, United States

Clinic Pharmacy

Durham, North Carolina, United States

Carolina Performance

Raleigh, North Carolina, United States

Health Park Pharmacy

Raleigh, North Carolina, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 33428284 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UG1DA040317

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00083544

Identifier Type: -

Identifier Source: org_study_id