Clinical trial NCT04139213: Medication Maintenance Therapy in Community Pharmacy Settings
Official title: Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Opioid-use Disorder
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
name: The Miriam Hospital
First posted: 2019-10-25
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* English speaking
* Currently enrolled at a MAT site for the treatment of OUD, maintained on a stable MAT (BNX, NTX) dose for at least 2 days or interested in induction
* Able and willing to provide written informed consent and secondary contact

Exclusion Criteria:

* currently pregnant or trying to get pregnant;
* plans to move or leave the state during the study, including pending legal action;
* self reported past year suicide attempt or self-reported past year suicidal thoughts with a plan;
* Patient is currently being treated for an acute illness or has a condition that is not stable including but not limited to an upcoming surgical procedure, hospitalization, or complex treatment regimen (e.g., chemotherapy, HCV treatment, has surgery scheduled, has procedures anticipated, has anticipated dose changes with other medication), that is likely to require ongoing, intense clinical management

Primary outcomes:
measure: Retention in MAT
timeFrame: up to 90 days post randomization
measure: Relapse to drug use
timeFrame: up to 90 days post randomization
Secondary outcomes:
measure: Primary care visits
timeFrame: up to 90 days post randomization
measure: Emergency department visits
timeFrame: up to 90 days post randomization
measure: Hospitalizations
timeFrame: up to 90 days post randomization
Other outcomes:
measure: Engagement in MAT
timeFrame: up to 30 days post randomization
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Rhode Island Hospital
name: Traci C Green, PhD, MSc
role: PRINCIPAL_INVESTIGATOR
References: