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Completed

NCT Number: NCT05259501

Remote Methadone Ingestion Surveillance Trial (RMIST)

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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNM Addiction and Substance Abuse Program

Albuquerque, New Mexico, 87106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RMIST

Other

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.

Primary outcomes

  1. Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE)

    Time frame: 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.

  2. Platform Usability as Measured by Number of Self-reported Instances Participants Need Assistance.

    Time frame: Day 2 to Day 20

    Number of instances participants needed assistance from clinic or study staff to complete the remote monitoring process.

  3. Methadone Treatment Adherence as Measured by the Number of Time-stamped Missed Detection Events (MDE).

    Time frame: 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.

Other outcomes

  1. Participant-perceived Advantages and Disadvantages of a Web-based Remote Methadone Ingestion Monitoring Platform

    Time frame: Day 20

    Measured by survey-based assessment designed to evaluate topics related to significant barriers to receiving opioid use disorder (OUD) treatments identified by the Substance Abuse and Mental Health Services Administration (SAMHSA) - acceptability and availability. 12 questions rated from Completely Disagree (0) to Completely Agree (4) with Completely Agree indicating perceived advantage. Highest advantage rating on this scale was 48; lowest 0.

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Feb 28, 2022
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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