NCT04139213

Medication Maintenance Therapy in Community Pharmacy Settings

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Lifespan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.

Detailed description

This study compares pharmacy-based medication assisted treatment (MAT) with usual care MAT. This will 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 community 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 completed initial phase of the study (Phase 1) involved a pilot of the pharmacy MAT care model. The current phase of the study (Phase 2) is a randomized controlled trial comparing the pharmacy MAT care model to usual MAT care. The aim of the current phase is to conduct a randomized controlled trial of 250 medication-stabilized (with BNX or NTX) patients with OUD receiving MAT care in Rhode Island, comparing engagement and clinical outcomes for patients followed up in a usual care model to those maintained and followed up in a pharmacy MAT care 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 or monthly 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 randomized to the pharmacy study arm and on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for up to three months. Patients will visit for check-ins with a pharmacist on a monthly, weekly, or more frequent basis, depending on the individual treatment plan. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it monthly by the pharmacist. All patients will visit the pharmacy at least monthly for addiction care (assessment, toxicological testing).
DRUG	oral naltrexone	To augment care for patients receiving injectable naltrexone for the treatment of OUD and treat cravings that may arise before their scheduled injection, patients prescribed injectable naltrexone may be provided a several day supply of oral naltrexone by a study pharmacist under a collaborative pharmacy practice agreement. The expected dose of oral naltrexone will be approximately 25-50 mg daily.

Timeline

• Start date: 2019-07-25
• Primary completion: 2022-09-30
• Completion: 2022-10-01
• First posted: 2019-10-25
• Last updated: 2022-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study