Remote Methadone Ingestion Surveillance Trial (RMIST)

July 21, 2026 updated by: Madhukar H. Trivedi, MD, University of Texas Southwestern Medical Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • UNM Addiction and Substance Abuse Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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 quick response (QR) security label.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Day 2 to Day 20
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.
Day 2 to Day 20
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.
Day 2 to Day 20

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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).
Time Frame: Months 1-6
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.
Time Frame: Months 1-6
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Day 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Texas Southwestern Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Drug Abuse (NIDA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Madhukar H Trivedi, MD, University of Texas Southwestern Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTN-0120 RMIST; STU-2023-0912
  • UG1DA020024 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

This study will comply with the National Institutes of Health (NIH) policy (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm). Investigators will also register and report results of the trial in ClinicalTrials.gov, consistent with the requirements of the Policy on the Dissemination of NIH-Funded Clinical Trial Information and the Clinical Trials Registration (https://grants.nih.gov/policy/clinical-trials/reporting/understanding/nih-policy.htm).

Primary data for this study will be available to the public in the NIDA data repository, per National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN) policy. For more details on data sharing please visit https://datashare.nida.nih.gov/.

The primary outcome publication will be included along with study underlying primary data in the data share repository, and it also will be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).

IPD Sharing Time Frame

Immediately following publication. No end date

IPD Sharing Access Criteria

Anyone who wishes to access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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