Remote Methadone Ingestion Surveillance Trial (RMIST)

NCT05259501 | Completed

• 2 other identifiers: CTN-0120 RMIST; STU-2023-0912UG1DA020024
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (2)

• 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.).

  Week 3

• 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).

  Weeks 1-3

Other Outcomes (1)

• Patient-perceived advantages and disadvantages of a web-based remote methadone ingestion monitoring platform

  Week 3

Study Arms (1)

Guided video recording with tamper-evident packaging

EXPERIMENTAL

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

Interventions

RMIST OTHER

RMIST will involve: 1. A study automated visual recognition web-based platform accessible on the participant's smartphone web browser. 2. A supply of methadone in single use bottles and previously described packaging to be kept securely at the methadone clinic/lab setting.

Guided video recording with tamper-evident packaging

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

UNM Addiction and Substance Abuse Program

Albuquerque, New Mexico, 87106, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Madhukar H Trivedi, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 10, 2022
• First Posted: February 28, 2022
• Study Start: January 15, 2025
• Primary Completion: March 13, 2025
• Study Completion: March 13, 2025
• Last Updated: December 23, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: Immediately following publication. No end date
• Access Criteria: Anyone who wishes to access the data

Locations

US (1)