Remote Methadone Ingestion Surveillance Trial (RMIST)

The University of Texas System (UT)

Status: Completed

Conditions: Opioid Use Disorder

Treatments: Other: RMIST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05259501

UG1DA020024 (U.S. NIH Grant/Contract)

CTN-0120 RMIST STU-2023-0912;

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Guided video recording with tamper-evident packaging

Experimental group

Description:

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.

Treatment:

Other: RMIST