The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
250
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.
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.
Rhode Island Hospital
Providence, Rhode Island, United States
Retention in MAT
Proportion of patients attending one or more visits with MAT providers every 30 days for up to 90 days post randomization according to the medical or pharmacy record
Time frame: up to 90 days post randomization
Relapse to drug use
Proportion of patients who relapse to drug use, defined as absence of the MAT medication and presence of heroin or other illicit opioids. Measured by toxicological (urine or oral) analysis, with samples collected at every visit (i.e., \<every 30 days), or at the 3-month interview at the research site. For patients attending visits, the toxicological results will consider those in the medical or pharmacy record. Urine or oral samples will test for drugs of abuse plus fentanyl, using a rapid qualitative immunoassay.
Time frame: up to 90 days post randomization
Primary care visits
Measured by patient self-report, patient medical record review, or by direct contact with the facility, clinician, or both. The self report item asks: How many times did you visit your primary care provider (do NOT count visits to providers at the emergency department) in the past 90 DAYS (since starting this study)? 1. Never, no provider 2. Never, but I have a provider 3. Once or twice 4. 3-5 times 5. 6 or more times
Time frame: up to 90 days post randomization
Emergency department visits
Measured by patient self-report, patient medical record review, or by direct contact with the facility, clinician, or both. The self report item asks: How often did you visit the emergency room in the past 90 DAYS (since starting this study)? 1. Never 2. Once or twice 3. 3-5 times 4. 6 or more times
Time frame: up to 90 days post randomization
Hospitalizations
Measured as by patient self-report, patient medical record review, or by direct contact with the facility, clinician, or both. The self report item asks: How often were you hospitalized in the past 90 DAYS (since starting this study)? 1. Never 2. Once or twice 3. 3-5 times 4. 6 or more times
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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).
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.
Time frame: up to 90 days post randomization