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| ID | Type | Description | Link |
|---|---|---|---|
| UG1DA020024 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guided video recording with tamper-evident packaging | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RMIST | Other | RMIST will involve:
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| Measure | Description | Time Frame |
|---|---|---|
| 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.). | Week 3 |
| 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). | Weeks 1-3 |
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| Measure | Description | Time Frame |
|---|---|---|
| Patient-perceived advantages and disadvantages of a web-based remote methadone ingestion monitoring platform | Measured by survey-based assessments designed to evaluate topics related to significant barriers to receiving OUD treatments identtified by the Substance Abuse and Mental Health Services Administration (SAMHSA) - acceptability, accessibility, and privacy. | Week 3 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Madhukar H Trivedi, MD | University of Texas Southwestern Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNM Addiction and Substance Abuse Program | Albuquerque | New Mexico | 87106 | United States |
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/).
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Immediately following publication. No end date
Anyone who wishes to access the data
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 2, 2026 | |
| Reset | Jun 26, 2026 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Dec 4, 2024 | Dec 18, 2025 | ICF_000.pdf |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 2, 2026 | Jun 26, 2026 |
| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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