NCT03766893

Medication Maintenance Therapy in Community Pharmacy Settings

Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Lifespan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to examine how the pharmacy can better optimize treatment expansion by providing pharmacy-based medication assisted treatment (MAT) for maintenance under a collaborative pharmacy practice agreement.

Detailed description

This study will be the first to develop and use a collaborative pharmacy practice agreement (CPA) for medication assisted treatment (MAT) intended for statewide application. This will also be the first study to use a randomized controlled trial design to test the multisite implementation of known effective interventions to treat opioid use disorder and prevent fatal opioid overdose (treatment with buprenorphine and natlrexone) in a pharmacy setting. Understanding how this model can improve engagement in care within innovative systems of MAT delivery like the Rhode Island Centers of Excellence in MAT model as well as the more traditional office based opioid therapy (OBOT) arrangement, and for patients with shorter and longer time on stabilized MAT doses advances the science of addiction health services. This study presents an opportunity to compare clinical outcomes of patients randomized to receive the same medications but in different settings that are equipped with differing levels of counseling expectations and access to wrap-around services. In this way, the trial helps to inform whether-and for whom--the limited support services in the pharmacy are sufficient to engage and retain patients in MAT, or if ready access to comprehensive services are necessary. Approximately 86% of Americans live within 5 miles of a pharmacy, making pharmacists the most accessible health care professionals. This model could redefine the role of the pharmacy. The initial phase of the study (Phase 1) involves preparation for and conduct of a pilot study of the pharmacy MAT care model. The aims of the first study phase (R21 grant) are: * Aim 1: Develop a pharmacy CPA for the management of opioid use disorder using buprenorphine and naltrexone. * Aim 2: For patient inmates maintained at the Rhode Island Department of Corrections, assess the feasibility and timing of randomization and transfer to a CPA pharmacy providing MAT post-release. This targeted assessment will inform the R33 design. * Aim 3: Pilot test the pharmacy MAT model with up to 12 patients, assessing feasibility of medication dispensing, administration, and monitoring in the pharmacy, and determining patient acceptability of this model.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
DRUG	Buprenorphine / Naloxone Oral Product	To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.
DRUG	injectable naltrexone	To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.
OTHER	Pharmacy maintenance addiction care	Patients on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing).

Timeline

• Start date: 2018-09-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2018-12-06
• Last updated: 2019-08-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study