Medication Maintenance Therapy in Community Pharmacy Settings

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.

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.