Ignite Creation Date:
2025-12-25 @ 1:17 AM
Ignite Modification Date:
2025-12-25 @ 11:26 PM
Study NCT ID:
NCT03766893
Status:
COMPLETED
Last Update Posted:
2019-08-01
First Post:
2018-10-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medication Maintenance Therapy in Community Pharmacy Settings
Sponsor:
Lifespan
Organization:
Study Overview
Official Title:
Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MATPharm
Brief 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: