Clinical trial NCT03766893: 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: COMPLETED
Phase: EARLY_PHASE1
Conditions: Opioid-use Disorder
Lead sponsor: Lifespan
Sponsor class: OTHER
Collaborators: name: University of Rhode Island
First posted: 2018-12-06
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older;
* English speaking; currently enrolled at a CODAC site in Rhode Island for the treatment of opioid use disorder;
* maintained on a stable dose of buprenorphine or injectable naltrexone for at least 2 days;
* no stable co-morbid illnesses likely to progress clinically during the pilot study;
* able and willing to provide written informed consent and locator information (working telephone and \>2 contacts) to participate.

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;
* any condition that, in the researchers' judgment, interferes with safe study participation or adherence to study procedures, including but not limited to a mental, medical or other substance use disorder that is likely to require ongoing, intense clinical management during the pilot study.

Primary outcomes:
measure: Pharmacists' dispensing of MAT medications
timeFrame: up to one month
measure: Pharmacists' monitoring of MAT care
timeFrame: up to one month
measure: Pharmacist-reported feasibility of executing the collaborative pharmacy practice: agreement for MAT: Likert scale
timeFrame: up to one month
measure: Patient acceptability of pharmacy-provided MAT care: Likert scale
timeFrame: up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
Study officials:
affiliation: Lifespan
name: Traci C Green
role: PRINCIPAL_INVESTIGATOR
References: