Medication Maintenance Therapy in Community Pharmacy Settings
- Conditions
- Opioid-use Disorder
- Interventions
- Drug: buprenorphine/naloxone oral productOther: Pharmacy maintenance addiction care
- Registration Number
- NCT04139213
- Lead Sponsor
- Lifespan
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 250
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Pharmacy MAT injectable naltrexone pharmacy-based medication assisted treatment for maintenance care of opioid use disorder Usual care oral naltrexone usual medication assisted treatment for maintenance care of opioid use disorder Usual care buprenorphine/naloxone oral product usual medication assisted treatment for maintenance care of opioid use disorder Usual care injectable naltrexone usual medication assisted treatment for maintenance care of opioid use disorder Pharmacy MAT oral naltrexone pharmacy-based medication assisted treatment for maintenance care of opioid use disorder Pharmacy MAT Pharmacy maintenance addiction care pharmacy-based medication assisted treatment for maintenance care of opioid use disorder Pharmacy MAT buprenorphine/naloxone oral product pharmacy-based medication assisted treatment for maintenance care of opioid use disorder
- Primary Outcome Measures
Name Time Method Retention in MAT up to 90 days post randomization 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
Relapse to drug use up to 90 days post randomization 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.
- Secondary Outcome Measures
Name Time Method Hospitalizations up to 90 days post randomization 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 timesPrimary care visits up to 90 days post randomization 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 timesEmergency department visits up to 90 days post randomization 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
Trial Locations
- Locations (1)
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States