Remote Methadone Ingestion Surveillance Trial (RMIST)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Remote Methadone Ingestion Surveillance Trial (RMIST): A Novel and Practical Opioid Use Disorder Treatment Approach During and After the COVID-19 Pandemic

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Other: RMIST


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guided video recording with tamper-evident packaging (RMIST Arm)<br>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 QR security label. | Other: RMIST<br>* RMIST will involve: A study automated visual recognition web-based platform accessible on the participant's smartphone web browser. A supply of methadone in single use bottles and previously described packaging to be kept securely at the methadone clinic/lab setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of the web-based monitoring platform | Opioid-negative (including fentanyl, excluding methadone) urine, verified by urine drug screens and self-reported days of use via the timeline follow-back (TLFB) assessment using the eliminate contradiction (ELCON) algorithm from CTN-0037 (STRIDE). | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methadone treatment adherence as measured by the number of time-stamped Medication Consumption Events (MCE) and Missed Detection Events (MDE). | Methadone treatment adherence as measured by the number of time-stamped Medication Consumption Events (MCE) and Missed Detection Events (MDE). i. MCEs occur any time a participant has consumed medication as detected by the web-based monitoring platform video recording. i. MDEs occur whenever a participant misses a dose during the dosing window and whenever there are user errors or platform issues. MDEs will be grouped based on commonly documented issues (e.g., platform malfunction, participant error, participant nonadherence, etc.). | Months 1-6 | 
| Platform usability as measured by number of and self-reported reasons for occasions participants need assistance. | Number of occasions participants needed assistance from clinic or study staff to complete the remote monitoring process and self-reported reasons for accidental MDSs (Missed Detection Events). | Months 1-6 |