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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
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Opioid Use Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    February 10, 2022
    Last Updated
    September 25, 2023
    Sponsor
    University of Texas Southwestern Medical Center
    Collaborators
    National Institute on Drug Abuse (NIDA)
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    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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