Remote Methadone Ingestion Surveillance Trial (RMIST): A Novel and Practical Opioid Use Disorder Treatment Approach During and After the Coronavirus Disease 2019 (COVID-19) Pandemic
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE)
研究概览
简要总结
The Remote Methadone Ingestion Surveillance Trial (RMIST) will explore a potential method of methadone ingestion surveillance that may mitigate patient safety risks of take-home methadone treatment regimens while minimizing the risk of diversion and evaluating the acceptability and feasibility of these monitoring methods. The method utilizes an innovative existing technology.
详细描述
The Remote Methadone Ingestion Surveillance Trial (RMIST) aims to evaluate the performance and acceptability of a remote methadone ingestion surveillance that may mitigate the patient safety risks of take-home methadone treatment regimens for opioid use disorder (OUD) while minimizing the risk of diversion. Data describing the monitoring performance and patient acceptability of the method will inform investigators of the feasibility of using remote surveillance technology to monitor medication for OUD and mitigate treatment barriers. This study will lay the groundwork for a safe and robust remotely monitored methadone treatment platform that addresses long-standing accessibility and acceptability barriers to treatment for OUD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be male or female, 18-65 years of age
- •Currently receiving methadone maintenance treatment (MMT) for the treatment of opioid use disorder (OUD)
- •Currently receiving a take-home methadone regimen of no more than three days per week (with or without COVID-19 exceptions)
- •Possess an internet-connected computer or smartphone with a front facing camera.
排除标准
- •Drug overdose requiring hospitalization within the last 12 months
- •Currently or soon to be in jail or prison; currently on probation; currently in any inpatient overnight facility as required by court of law or have pending legal action or other situation that could prevent participation in the study or in any study activities
- •Pregnant women
- •Serious psychiatric disorders that would interfere with study participation as determined by the study site Medical Clinician
- •Any participant that, according to the study team, may find it difficult to adhere to study procedures (e.g., no internet access, etc.) or are unable to operate the web-based platform for remote methadone ingestion
研究组 & 干预措施
Guided video recording with tamper-evident packaging
This method uses automated visual recognition web-based platform and QR tamper-evident labels to enhance the security of the take-home regimen currently used in methadone clinics. Single-use liquid methadone bottles are made tamper-evident through the application of a quick response (QR) security label.
干预措施: RMIST (Other)
结局指标
主要结局
Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE)
时间窗: Day 2 to Day 20
Methadone treatment adherence as measured by the number of time-stamped Medication Consumption Events (MCE). MCEs occur any time a participant has consumed medication as detected by the web-based monitoring platform video recording.
Platform Usability as Measured by Number of Self-reported Instances Participants Need Assistance.
时间窗: Day 2 to Day 20
Number of instances participants needed assistance from clinic or study staff to complete the remote monitoring process.
Methadone Treatment Adherence as Measured by the Number of Time-stamped Missed Detection Events (MDE).
时间窗: Day 2 to Day 20
Methadone treatment adherence as measured by the average of time-stamped Missed Detection Events (MDE). MDEs occur whenever a participant misses a dose during the dosing window and whenever there are user errors or platform issues.
次要结局
未报告次要终点
研究者
Madhukar H. Trivedi, MD
Professor of Medicine
University of Texas Southwestern Medical Center