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

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

71

Participants

Timeline

Start Date

March 28, 2018

Primary Completion Date

June 27, 2019

Study Completion Date

June 27, 2019

Conditions
Opioid Use Disorder
Interventions
DRUG

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.

OTHER

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.

Trial Locations (6)

27615

Carolina Performance, Raleigh

Health Park Pharmacy, Raleigh

27704

Duke Outpatient Clinic, Durham

Josefs Pharmacy, Durham

27705

Changes by Choice, Durham

Clinic Pharmacy, Durham

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

collaborator

The Emmes Company, LLC

INDUSTRY

lead

Duke University

OTHER

NCT03248947 - Buprenorphine Physician-Pharmacist Collaboration in the Management of Patients With Opioid Use Disorder: CTN 0075 | Biotech Hunter | Biotech Hunter