Meyerson Beth E, Davis Alissa, Crosby Richard A, Linde-Krieger Linnea B, Brady Benjamin R, Carter Gregory A, Mahoney Arlene N, Frank David, Rothers Janet, Coffee Zhanette, Deuble Elana, Ebert Jonathon, Jablonsky Mary F, Juarez Marlena, Lee Barbara, Lorenz Heather M, Pava Michael D, Tinsely Kristen, Yousaf Sana
Harm Reduction Research Lab, University of Arizona College of Medicine-Tucson, Tucson, AZ, United States.
Comprehensive Center for Pain and Addiction, University of Arizona Health Sciences, University of Arizona, Tucson, AZ, United States.
JMIR Res Protoc. 2025 Apr 15;14:e69829. doi: 10.2196/69829.
Access to methadone treatment can reduce opioid overdose death by up to 60%, but US patient outcomes are suboptimal. Federally allowed methadone treatment accommodations during the COVID-19 public health emergency were not widely adopted. It is likely that staff-level characteristics such as trauma symptoms influence the adoption of treatment innovation.
Methadone Patient Access to Collaborative Treatment (MPACT) is a 2-phased project (pilot and field trial) to develop and test a staff-level, multimodal intervention to increase staff adoption of low-barrier, patient-centered methadone treatment practices and ultimately improve treatment retention and patient outcomes.
A pilot and national trial will measure implementation feasibility, acceptability, and effects of the MPACT intervention on treatment practice change, clinic culture, patient retention, and patient posttraumatic stress symptoms (PTSS). The pilot will be a single-arm 5.5-month pilot study of MPACT conducted in 2 Arizona methadone treatment clinics (rural and urban) among 100 patients and 22 staff. The national trial will be a 20-month cluster randomized trial conducted among 30 clinics, 600 patients (20 per clinic), and 480 staff (18 per clinic). Data will be gathered by staff and patient surveys and patient chart review. The primary study outcome is increased patient methadone treatment retention measured as (1) time to first treatment interruption from study enrollment; (2) active in treatment at enrollment, day 30, 60, 90, and 120; and (3) continuous days in treatment during the study period. Secondary study outcomes include reductions in vicarious trauma and PTSS among enrolled opioid treatment program staff and PTSS among enrolled patients.
The pilot study was funded by the National Institute on Drug Abuse (award R61DA059889, funded September 2023), and the field trial will be funded under the associated R33 mechanism in September 2025. The pilot study was completed in March 2025. The randomized controlled trial will begin in December 2025. Both the pilot and trial have been approved by the University of Arizona Human Subjects Protection Program and have been registered with the clinical trials network.
The MPACT study will provide a foundation for an evidence-based, staff-level intervention aimed at improving patient retention in methadone treatment. Future studies should examine the individual components of MPACT to determine their differential contributions to the primary outcome of patient methadone treatment retention and to secondary outcomes of staff and patient reduction in stress symptoms.
ClinicalTrials.gov NCT06513728; https://clinicaltrials.gov/study/NCT06513728 and ClinicalTrials.gov NCT06556602; https://clinicaltrials.gov/study/NCT06556602.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/69829.
接受美沙酮治疗可将阿片类药物过量致死率降低多达60%，但美国患者的治疗效果并不理想。在2019冠状病毒病公共卫生紧急事件期间，联邦政府允许的美沙酮治疗便利措施并未得到广泛采用。诸如创伤症状等工作人员层面的特征可能会影响治疗创新措施的采用。
美沙酮患者协作治疗准入项目（MPACT）是一个分两阶段的项目（试点和现场试验），旨在开发并测试一种工作人员层面的多模式干预措施，以提高工作人员对低门槛、以患者为中心的美沙酮治疗实践的采用率，并最终改善治疗留存率和患者治疗效果。
一项试点研究和全国性试验将衡量MPACT干预措施在实施可行性、可接受性以及对治疗实践改变、诊所文化、患者留存率和患者创伤后应激症状（PTSS）方面的效果。试点研究将是在亚利桑那州的2家美沙酮治疗诊所（一家农村诊所和一家城市诊所）针对100名患者和22名工作人员开展的为期5.5个月的MPACT单组试验研究。全国性试验将是在30家诊所、600名患者（每家诊所20名）和480名工作人员（每家诊所18名）中开展的为期20个月的整群随机试验。数据将通过工作人员和患者调查以及患者病历审查收集。主要研究结果是患者美沙酮治疗留存率提高，衡量指标为：（1）从研究入组到首次治疗中断的时间；（2）在入组时、第30天、60天、90天和12天仍在接受治疗；（3）研究期间连续治疗天数。次要研究结果包括减少参与研究的阿片类药物治疗项目工作人员的替代性创伤和PTSS以及参与研究的患者的PTSS。
试点研究由美国国家药物滥用研究所资助（资助编号R61DA059889，2023年9月获得资助），现场试验将于2025年9月根据相关的R33机制获得资助。试点研究于2025年3月完成。随机对照试验将于2025年12月开始。试点研究和现场试验均已获得亚利桑那大学人类受试者保护项目的批准，并已在临床试验网络注册。
MPACT研究将为旨在提高美沙酮治疗患者留存率的循证工作人员层面干预措施奠定基础。未来的研究应考察MPACT的各个组成部分，以确定它们对患者美沙酮治疗留存率这一主要结果以及工作人员和患者压力症状减轻这一次要结果的不同贡献。
ClinicalTrials.gov NCT06513728；https://clinicaltrials.gov/study/NCT06513728 以及ClinicalTrials.gov NCT06556602；https://clinicaltrials.gov/study/NCT06556602。
国际注册报告识别码（IRRID）：DERR1-10.2196/69829。
