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

NCT03248947 | Completed Early Phase 1 Results DMC FDA Drug

• 2 other identifiers: Pro00083544UG1DA040317
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 6

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.

Conditions

Opioid Use Disorder

Keywords

opioid use disorder; Medication-assisted treatment; Buprenorphine treatment; Collaborative care model

Outcome Measures

Primary Outcomes (4)

• Recruitment Rate

  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.

  Up to six months

• Treatment Retention

  Number of scheduled visits completed.

  Up to six months

• Number of Participants With Opioid and Other Substance Use

  Measured via a composite of urine drug screen (UDS) and self-report via Timeline Follow-Back over 30 days.

  Up to six months

• Number of Medication-Compliant Months Across All Participants

  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.

  Up to six months

Secondary Outcomes (4)

• Treatment Fidelity

  Up to six months

• Treatment Satisfaction

  Up to six months

• Participant Safety

  Up to six months

• Pharmacists' Use of the Prescription Drug Monitoring Program (PDMP)

  Up to six months

Study Arms (1)

Pharmacy opioid use disorder care

OTHER

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.

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

Interventions

buprenorphine/naloxone 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.

Pharmacy opioid use disorder care

Pharmacist-administered buprenorphine/naloxone maintenance care 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.

Pharmacy opioid use disorder care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• The Emmes Company, LLC: collaborator

Study Sites (6)

Duke Outpatient Clinic

Durham, North Carolina, 27704, United States

Location

Josefs Pharmacy

Durham, North Carolina, 27704, United States

Location

Changes by Choice

Durham, North Carolina, 27705, United States

Location

Clinic Pharmacy

Durham, North Carolina, 27705, United States

Location

Carolina Performance

Raleigh, North Carolina, 27615, United States

Location

Health Park Pharmacy

Raleigh, North Carolina, 27615, United States

Location

Related Publications (1)

• 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.

  PMID: 33428284 RESULT

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Buprenorphine, Naloxone Drug Combination

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Buprenorphine; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Naloxone; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Li-Tzy Wu
• Organization: Duke University

litzy.wu@duke.edu

919-889-9369

Study Officials

• Li-Tzy Wu, Sc.D.

  Professor

  PRINCIPAL INVESTIGATOR

• Paolo Mannelli, M.D.

  Associate Professor

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 15, 2017
• Study Start: March 28, 2018
• Primary Completion: June 27, 2019
• Study Completion: June 27, 2019
• Last Updated: July 28, 2021
• Results First Posted: August 10, 2020

Record last verified: 2021-07

Locations

US (6)