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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to monitor methadone use at home for individuals with opioid use disorder. The goal is to ensure safety and prevent misuse through video technology and special packaging. The trial aims to determine if this method, known as L-RMIST, RMIST, or T-RMIST, is easy and acceptable for patients. Individuals currently on a take-home methadone plan, using it no more than three times a week, and possessing a smartphone or computer with a camera might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative solutions for safer methadone use.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves methadone treatment, you will need to continue your methadone regimen.

What prior data suggests that this method is safe for remote methadone monitoring?

Research has shown that methadone is usually well-tolerated for treating opioid addiction. It has been a common treatment for many years and is generally safe when used as directed. However, it can cause side effects such as drowsiness, nausea, and sweating.

This trial tests new methods to monitor methadone use at home to enhance safety. Special packaging will indicate tampering, and video recording will track its use. This approach does not alter the methadone itself, only the monitoring process.

Methadone's safety is well-supported by research. This trial aims to enhance its safety for home use, potentially reducing risks like misuse. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for remote methadone monitoring because it introduces a new level of security and convenience for patients with opioid use disorder. Unlike standard methadone treatments, which involve frequent clinic visits, this trial uses a tamper-evident packaging system featuring QR security labels to ensure the integrity of take-home methadone doses. Additionally, the innovative use of a web-based platform with automated visual recognition allows for remote monitoring, which could enhance treatment adherence and reduce the burden on patients to visit clinics regularly. This approach has the potential to make methadone treatment more accessible and secure, which could lead to better outcomes for individuals struggling with opioid addiction.

What evidence suggests that this method is effective for opioid use disorder?

Research has shown that medications like methadone effectively help people with opioid use disorder (OUD). Long-term use of these medications can reduce drug use and improve both physical and mental health. Specifically, after six months of treatment with medication, patients often feel better and experience fewer symptoms. This trial studies the RMIST method, which includes guided video recording with tamper-evident packaging, to ensure the safe use of methadone. This new monitoring method may further enhance positive outcomes by reducing risks. ^{6 7 8 9 10}

Who Is on the Research Team?

Madhukar H Trivedi, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9705076/

Using Data Science to Improve Outcomes for Persons with ... Even if patients receive MOUD, 40%-55% of persons discontinue MOUD within a year after initiation, and recent data show a six-fold increase in mortality in the ...

2. cdc.gov cdc.gov/mmwr/volumes/73/wr/mm7325a1.htm

Treatment for Opioid Use Disorder: Population Estimates In 2022, 3.7% of US adults aged ≥18 years needed OUD treatment. Among these, only 25.1% received medications for OUD.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK541393/

The Effectiveness of Medication-Based Treatment for Opioid ... Long-term retention on medication for OUD is associated with improved outcomes. A lack of availability of behavioral interventions is not a sufficient ...

4. recoveryanswers.org recoveryanswers.org/research-post/long-term-treatment-outcomes-for-individuals-with-opioid-use-disorders/

Long-Term Treatment Outcomes for Individuals with Opioid ... This study with 42 months (ie, 3.5 years) of follow-up focuses solely on the outcomes of patients with prescription opioid use disorder.

5. substanceabusepolicy.biomedcentral.com substanceabusepolicy.biomedcentral.com/articles/10.1186/s13011-021-00424-4

Outcomes from the medication assisted treatment pilot ... This study shows decreased substance use, improved physical and mental health, and reduced symptoms after 6 months of MOUD.

6. nida.nih.gov nida.nih.gov/about-nida/organization/cctn/ctn/research-studies/r-mist-remote-methadone-ingestion-surveillance-trial

R-Mist: Remote Methadone Ingestion Surveillance Trial - NIDA The Remote Methadone Ingestion Surveillance Trial (R-MIST) aims to evaluate the performance and acceptability of two different methods of remote methadone ...

7. reporter.nih.gov reporter.nih.gov/search/I_bJWIRR_0Kb3TKRVha0zw/project-details/10857323

RePORT ⟩ RePORTER We're sorry but RePORTER doesn't work properly without JavaScript enabled. Please enable it to continue.

8. cdc.gov cdc.gov/overdose-prevention/data-research/facts-stats/moud-study.html

Medications for Opioid Use Disorder (MOUD) Study The MOUD study examined patient outcomes from several opioid use disorder (OUD) treatments.

9. go.drugbank.com go.drugbank.com/conditions/DBCOND0110310

Opioid Use Disorder (OUD) (DBCOND0110310) - DrugBank Following Outcomes Remotely Within Addiction Recovery Domains, No drug ... Remote Methadone Ingestion Surveillance Trial (RMIST), No drug interventions ...

10. recoveryanswers.org recoveryanswers.org/research-post/promising-evidence-mobile-engagement-units-link-hard-to-reach-individuals-opioid-use-disorder-medication-treatment/

Promising evidence that mobile engagement units can link ... In this study, researchers examined the effectiveness of a mobile engagement unit in Philadelphia to connect individuals with opioid use disorder to a methadone ...