Remote Methadone Ingestion Surveillance Trial (RMIST)
Primary Purpose
Opioid Use Disorder
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
RMIST
Sponsored by
About this trial
This is an interventional health services research trial for Opioid Use Disorder
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Guided video recording with tamper-evident packaging (RMIST Arm)
Arm Description
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.
Outcomes
Primary Outcome Measures
Feasibility of the web-based monitoring platform
Opioid-negative (including fentanyl, excluding methadone) urine, verified by urine drug screens and self-reported days of use via the timeline follow-back (TLFB) assessment using the eliminate contradiction (ELCON) algorithm from CTN-0037 (STRIDE).
Secondary Outcome Measures
Methadone treatment adherence as measured by the number of time-stamped Medication Consumption Events (MCE) and Missed Detection Events (MDE).
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.).
Platform usability as measured by number of and self-reported reasons for occasions participants need assistance.
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).
Full Information
NCT ID
NCT05259501
First Posted
February 10, 2022
Last Updated
September 25, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
1. Study Identification
Unique Protocol Identification Number
NCT05259501
Brief Title
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
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 1, 2024 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute on Drug Abuse (NIDA)
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Guided video recording with tamper-evident packaging (RMIST Arm)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
RMIST
Intervention Description
RMIST will involve:
A study automated visual recognition web-based platform accessible on the participant's smartphone web browser.
A supply of methadone in single use bottles and previously described packaging to be kept securely at the methadone clinic/lab setting.
Primary Outcome Measure Information:
Title
Feasibility of the web-based monitoring platform
Description
Opioid-negative (including fentanyl, excluding methadone) urine, verified by urine drug screens and self-reported days of use via the timeline follow-back (TLFB) assessment using the eliminate contradiction (ELCON) algorithm from CTN-0037 (STRIDE).
Time Frame
Month 6
Secondary Outcome Measure Information:
Title
Methadone treatment adherence as measured by the number of time-stamped Medication Consumption Events (MCE) and Missed Detection Events (MDE).
Description
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.).
Time Frame
Months 1-6
Title
Platform usability as measured by number of and self-reported reasons for occasions participants need assistance.
Description
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).
Time Frame
Months 1-6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Madhukar Trivedi, MD
Phone
214-648-0188
Email
madhukar.trivedi@utsouthwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Madhukar H Trivedi, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
This study will comply with the NIH Data Sharing Policy and Implementation Guidance (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 NIDA 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 URL
https://datashare.nida.nih.gov/
Learn more about this trial
Remote Methadone Ingestion Surveillance Trial (RMIST)
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