CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 71 enrolled
Drug / intervention
buprenorphine/naloxone +1 moredrug
Likely dose
buprenorphine/naloxone 16 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03248947
NCT03248947Early Ph 1Completed

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

Duke University·interventional·Posted Aug 15, 2017·Updated Jul 28, 2021

In Brief

A Early Phase 1 clinical trial evaluating buprenorphine/naloxone and Pharmacist-administered buprenorphine/naloxone maintenance care for Opioid Use Disorder. Completed, enrolled 71 participants across 6 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 15, 2017
Enrollment StartMar 28, 2018
Primary CompletionJun 27, 2019
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 8.9 years ago

Interventions

buprenorphine/naloxonedrug

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 careother

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.