Clinical trial NCT05259501: Remote Methadone Ingestion Surveillance Trial (RMIST)
Official title: Remote Methadone Ingestion Surveillance Trial (RMIST): A Novel and Practical Opioid Use Disorder Treatment Approach During and After the COVID-19 Pandemic
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-02-28
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Methadone treatment adherence as measured by the number of time-stamped Medication Consumption Events (MCE) and Missed Detection Events (MDE).
timeFrame: Week 3
measure: Platform usability as measured by number of and self-reported reasons for occasions participants need assistance.
timeFrame: Weeks 1-3
Secondary outcomes:
Other outcomes:
measure: Patient-perceived advantages and disadvantages of a web-based remote methadone ingestion monitoring platform
timeFrame: Week 3
Locations:
city: Albuquerque
country: United States
facility: UNM Addiction and Substance Abuse Program
state: New Mexico
Study officials:
affiliation: UT Southwestern Medical Center
name: Madhukar H Trivedi, MD
role: PRINCIPAL_INVESTIGATOR
References: