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Remote Methadone Ingestion Surveillance Trial (RMIST)

NCT ID: NCT05259501

Last Updated: 2025-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-15

Study Completion Date

2025-03-13

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.

Conditions

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Opioid Use Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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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 QR security label.

Group Type EXPERIMENTAL

RMIST

Intervention Type 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.

Interventions

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RMIST

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.

Intervention Type OTHER

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Madhukar H. Trivedi, MD

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Madhukar H Trivedi, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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UNM Addiction and Substance Abuse Program

Albuquerque, New Mexico, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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UG1DA020024

Identifier Type: NIH

Identifier Source: secondary_id

View Link

CTN-0120 RMIST; STU-2023-0912

Identifier Type: -

Identifier Source: org_study_id