Trial Outcomes & Findings for Remote Methadone Ingestion Surveillance Trial (RMIST) (NCT NCT05259501)
NCT ID: NCT05259501
Last Updated: 2026-08-13
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
Day 2 to Day 20
Results posted on
2026-08-13
Participant Flow
Recruitment took place at a methadone clinic associated with the University of New Mexico from 01/10/2025 - 02/25/2025.
Participant milestones
| Measure |
Guided Video Recording With Tamper-evident Packaging
This method uses automated visual recognition web-based platform and quick response (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.
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.
|
|---|---|
|
Overall Study
STARTED
|
15
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Guided Video Recording With Tamper-evident Packaging
This method uses automated visual recognition web-based platform and quick response (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.
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.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Screen Failure
|
1
|
Baseline Characteristics
Remote Methadone Ingestion Surveillance Trial (RMIST)
Baseline characteristics by cohort
| Measure |
Guided Video Recording With Tamper-evident Packaging
n=14 Participants
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.
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=1 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=1 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=1 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=1 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=1 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=1 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=1 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=1 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=1 Participants
|
|
Baseline: The Subjective Opiate Withdrawal Scale (SOWS)
|
9 scores on a scale
STANDARD_DEVIATION 9 • n=1 Participants
|
PRIMARY outcome
Timeframe: Day 2 to Day 20Population: Sonara dataset: Medication Consumption Events
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.
Outcome measures
| Measure |
Guided Video Recording With Tamper-evident Packaging
n=14 Participants
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.
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.
|
|---|---|
|
Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE)
|
10.36 Medication Consumption Events
Standard Deviation 3.4
|
PRIMARY outcome
Timeframe: Day 2 to Day 20Number of instances participants needed assistance from clinic or study staff to complete the remote monitoring process.
Outcome measures
| Measure |
Guided Video Recording With Tamper-evident Packaging
n=14 Participants
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.
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.
|
|---|---|
|
Platform Usability as Measured by Number of Self-reported Instances Participants Need Assistance.
|
2.4 Number of instances
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: Day 2 to Day 20Methadone 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.
Outcome measures
| Measure |
Guided Video Recording With Tamper-evident Packaging
n=14 Participants
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.
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.
|
|---|---|
|
Methadone Treatment Adherence as Measured by the Number of Time-stamped Missed Detection Events (MDE).
|
0.41 missed events
Standard Deviation 0.016
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 20Measured 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.
Outcome measures
| Measure |
Guided Video Recording With Tamper-evident Packaging
n=13 Participants
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.
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.
|
|---|---|
|
Participant-perceived Advantages and Disadvantages of a Web-based Remote Methadone Ingestion Monitoring Platform
|
44.92 scores on a scale
Standard Deviation 5.1
|
Adverse Events
Guided Video Recording With Tamper-evident Packaging
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Madhukar H. Trivedi, MD
University of Texas Southwestern Medical Center
Phone: 214-648-4689
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place