Opioid Use DisorderNCT05259501

Remote Methadone Ingestion Surveillance Trial (RMIST)

A study testing RMIST in people with Opioid Use Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Opioid Use Disorder
What is being tested?: RMIST
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 15 Jan 2025to 13 Mar 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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 locations and contacts

1 site in 1 country.

United States1 site

UNM Addiction and Substance Abuse Program
Albuquerque, New Mexico, 87106

Other trials in United States

About this study

Official 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

Read the 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.

Conditions: Opioid Use Disorder
Being tested: RMIST
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

RMISTOther
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.

Study groups in NCT05259501
Study group	Role	What they receive
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 quick response (QR) security label. Receives: Other: RMIST

What is being measured

The primary outcome is the main question the study is designed to answer.

Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE)
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.
Measured: Day 2 to Day 20
Platform Usability as Measured by Number of Self-reported Instances Participants Need Assistance.
Number of instances participants needed assistance from clinic or study staff to complete the remote monitoring process.
Measured: Day 2 to Day 20
Methadone Treatment Adherence as Measured by the Number of Time-stamped Missed Detection Events (MDE).
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.
Measured: Day 2 to Day 20

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202513 Mar 2025

First posted28 Feb 2022
Study start15 Jan 2025
Primary completion13 Mar 2025
Study completion13 Mar 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05259501
Sponsor's protocol ID: CTN-0120 RMIST; STU-2023-0912
Other IDs: UG1DA020024
Status last verified: Jul 2026
First submitted: 10 Feb 2022
Last updated: 13 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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/).

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
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Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder

All Opioid Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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
ClinicalTrials.gov ID: NCT05259501
Acronym / sponsor ID: CTN-0120 RMIST; STU-2023-0912
Conditions: Opioid Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: University of Texas Southwestern Medical CenterUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 15 Jan 2025 (actual)
Primary completion: 13 Mar 2025 (actual)
Study completion: 13 Mar 2025 (actual)
First posted: 28 Feb 2022 (actual)
Results: Posted 13 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Guided video recording with tamper-evident packaging	Experimental	Other: RMISTThis 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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RMISTRMIST 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.	Other	Guided video recording with tamper-evident packaging

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 13 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Guided Video Recording With Tamper-evident Packaging	15	13

Primary outcome: Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE)

Time frame: Day 2 to Day 20. Mean (Standard Deviation). Unit: Medication Consumption Events

Measure	Guided Video Recording With Tamper-evident Packaging n = 14
Value	10.36 (3.4)

Population analysed: Sonara dataset: Medication Consumption Events

Primary outcome: Platform Usability as Measured by Number of Self-reported Instances Participants Need Assistance.

Time frame: Day 2 to Day 20. Mean (Standard Deviation). Unit: Number of instances

Measure	Guided Video Recording With Tamper-evident Packaging n = 14
Value	2.4 (1.7)

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

Time frame: Day 2 to Day 20. Mean (Standard Deviation). Unit: missed events

Measure	Guided Video Recording With Tamper-evident Packaging n = 14
Value	0.41 (0.016)

Adverse events

Time frame: Adverse Events were not collected. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Guided Video Recording With Tamper-evident Packaging	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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/).

Related trials for Opioid Use Disorder

Not yet recruiting
Remote Intervention to Prevent Overdose
Accidental Overdose of Opiate
Active, not recruiting
Healing Opioid Misuse and Pain Through Engagement (HOPE) Trial
Opioid Use Disorder, Chronic Pain
Enrolling by invitationObservational study
Development of an Interview-Informed Timeline Follow-Back (TLFB) for Opioid Use in the Era of Fentanyl
Substance Use Disorders (SUDs)
Not yet recruiting
Peer-led, Mobile App Supported Linkage to Opioid Use Disorder Treatment
Opioid Use Disorder
Active, not recruiting
Pain and Opioids: Integrated Treatment In Veterans
Chronic Pain, Opioid-use Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Madhukar H Trivedi, MD principal investigator

University of Texas Southwestern Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing RMIST in people with Opioid Use Disorder, run by University of Texas Southwestern Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE) (time frame: Day 2 to Day 20). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05259501.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2026.