Opioid Use Disorder
Conditions
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.
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.
Interventions
OTHERRMIST
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.
Sponsors
University of Texas Southwestern Medical Center
National Institute on Drug Abuse (NIDA)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Methadone Treatment Adherence as Measured by the Number of Time-stamped Medication Consumption Events (MCE) | 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. | 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). | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORMadhukar H Trivedi, MD
University of Texas Southwestern Medical Center
Participant flow
Recruitment details
Recruitment took place at a methadone clinic associated with the University of New Mexico from 01/10/2025 - 02/25/2025.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Baseline: The Subjective Opiate Withdrawal Scale (SOWS) | 9 scores on a scale STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 14 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
None listed