Comparing Medication Maintenance in Comprehensive Community and Pharmacy Settings to Enhance Engagement
试验速览
- 阶段
- 2 期
- 发起方
- Lifespan
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Retention in MAT
研究概览
简要总结
The goal of this study is to compare pharmacy-based medication assisted treatment (MAT) with usual care MAT for people with opioid use disorder.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Usual care
usual medication assisted treatment for maintenance care of opioid use disorder
干预措施: buprenorphine/naloxone oral product (Drug)
Usual care
usual medication assisted treatment for maintenance care of opioid use disorder
干预措施: injectable naltrexone (Drug)
Usual care
usual medication assisted treatment for maintenance care of opioid use disorder
干预措施: oral naltrexone (Drug)
Pharmacy MAT
pharmacy-based medication assisted treatment for maintenance care of opioid use disorder
干预措施: buprenorphine/naloxone oral product (Drug)
Pharmacy MAT
pharmacy-based medication assisted treatment for maintenance care of opioid use disorder
干预措施: injectable naltrexone (Drug)
Pharmacy MAT
pharmacy-based medication assisted treatment for maintenance care of opioid use disorder
干预措施: Pharmacy maintenance addiction care (Other)
Pharmacy MAT
pharmacy-based medication assisted treatment for maintenance care of opioid use disorder
干预措施: oral naltrexone (Drug)
结局指标
主要结局
Retention in MAT
时间窗: 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
时间窗: 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.
次要结局
- Hospitalizations(up to 90 days post randomization)
- Primary care visits(up to 90 days post randomization)
- Emergency department visits(up to 90 days post randomization)