Remote Methadone Monitoring for Opioid Use Disorder

Overseen By Manish Jha, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Methadone

Disqualifiers: Recent overdose, Legal issues, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Madhukar H Trivedi, MD

Principal Investigator

UT Southwestern Medical Center

Eligibility Criteria

This trial is for men and women aged 18-65 with Opioid Use Disorder who are currently on a take-home methadone treatment no more than three times a week. Participants must have internet access and a device with a camera to be eligible.

Inclusion Criteria

I take methadone at home up to three times a week.

I am on methadone treatment for opioid addiction.

Possess an internet-connected computer or smartphone with a front facing camera.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in remote methadone ingestion surveillance using a web-based platform with tamper-evident packaging

3 weeks

Remote monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• L-RMIST
• RMIST
• T-RMIST

Trial Overview RMIST is being tested as an innovative method to monitor the ingestion of methadone remotely, aiming to improve patient safety, reduce the risk of drug diversion, and assess how acceptable and feasible this technology-based monitoring is.

Participant Groups

Group I: Guided video recording with tamper-evident packaging Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+