Remote health monitoring company Sonara Health is the latest recipient of a $2.5m grant from the US Government’s National Institute on Drug Abuse (NIDA) aimed at driving the company’s remote monitoring app for methadone treatment management.

The grant will be used to advance a Phase II trial,  the Remote Observed Methadone Evaluation (ROME) study that will evaluate the company’s remote monitoring platform that uses a patient’s phone camera to record the user taking their methadone as prescribed when prescribed.

Additionally, the company also provides tamper-proof take-home bottles of methadone embedded with a QR code synchronised to the app. This is to allow care providers to enable patients to take amounts of methadone home with them and self-administer at home, as opposed to the traditional method of having to line up at a designated clinic when a dose is required.

The Phase II trial will look to examine how the app impacts treatment retention and overall opioid use, as well as impacts insurance costs alongside impacts on overall treatment quality. Set to take place at clinics across the Chicago area alongside healthcare providers Chestnut Health Systems and Family Guidance, as the company looks to expand its methadone remote monitoring system across the US.

A report published by GlobalData details how the global market for telehealth apps was estimated to be $2bn in 2020, but is estimated to rise to $5bn by the end of this year. Further growth is projected into 2030 where it’s estimated to hit $12bn dollars. Conversely, remote monitoring apps are estimated to see a value of $760m by the end of 2030.

To find out more, Medical Device Network sat down with Sonara Health CEO, Michael Giles, to understand why remote monitoring technology can find itself so at home in the field of methadone treatment and how that can help keep patients from relapsing into bad habits or falling out of treatment systems entirely.

Joshua Silverwood (JS): Can you tell me what the $2.5m grant will be used for?

Michael Giles (MG): So, NIDA, the department within the National Institutes of Health (NIH) gave us the grant to examine Sonara’s impact on things like cost reduction, and specifically non-emergency medical transportation cost reduction, as well as retention and treatment. Those are the two primary outcomes. We will be collecting a couple of measures, such as looking at the visual analogue craving scale. So, assessing the impact of cravings and how the trend over time after using Sonara as they receive more doses of methadone. We have discussions going on about adding other measures as well so there will probably be a dozen or so other measurements, we add by the time the study launches.

Another important aspect is provider comfort around take-homes. That’s one of the big things we really wanted to address. We wanted to allow the provider to feel more confident to use take-home privileges more liberally.

JS: Why do you think remote monitoring technology is so crucial in methadone treatment

MG: Methadone can only be dispensed in the US from federally certified opioid treatment programmes (OTPs). There are about 2,000 of these OTPs in the United States, which isn’t very many. Standard pharmacies can't dispense methadone, only OTPs can and the standard of care for patients who are still early in treatment is to go into the clinic all the time, in many cases daily so that they can take one dose of medication.

Sometimes there are lines at these clinics, sometimes the patient might have obligations that interfere with them being able to be at the clinic every day, and they drop out of treatment. If you go to school, if you have kids, if you have a job, going to the clinic every single day is often totally unsustainable and those patients will end up dropping out of treatment and trying to control their condition using illegal opioids.

So, the solution is to figure out how to get patients to have more doses of take-home methadone. Sonata is designed to let patients demonstrate to their provider how they're using their methadone at home so that they can prove to the provider they're doing what they need to do with the methadone as prescribed. They are using it safely. Eventually, they won't even need to use Sonara anymore once the provider is sure that it is safe just to give a patient their medicine.

JS: From previous trials, can you speak to the impact Sonara has had on patients?

MG: So, anecdotally, it looks as though our 90-day retention rate is about 15% higher than the industry standard retention rate for the same amount of time. At the high end of the industry standard, approximately 70% of patients stay in treatment after 90 days, and we are seeing 85%, which is substantial. The Phase II trial will be in the Chicago area, but our platform so far is being used in 13 different states now from Florida to Alaska.

JS: Will the results of this Phase II trial be used to appeal for further funding?

MG: Absolutely, we want providers to be incentivised by the higher quality of care remote therapeutic monitoring offers, as well as the recovery space. When a patient doesn’t take their medication, that generally means one of two things. Either they need a higher dose, or they just aren’t taking the medication. It has a direct clinical impact on the treatment plan when patients aren’t taking their medication.

Hospital groups have occasionally thought of setting up their own OTP, but they often haven't done it because they don't want that kind of clientele lining up outside of their hospital. If you were to set up an OTP that was built around our technology, you wouldn't have that problem. So, we would love it if our technology could lower the barrier of entry for providers who are curious about providing methadone services for patients.

JS: Have you included any cybersecurity considerations with the app?

MG: We aren’t a cybersecurity company so the backend is taken care of by systems built on work by tech giants such as the Google Cloud platform and their own healthcare infrastructure. So, they worry about the security aspects. Though of course, no one has access to any of the data we collect, and we are not sharing anything with groups such as Facebook etc, it’s all purely for the provider.

The topic of methadone treatment has never been the most glamourous or attractive field of medical investment, but with NIDA itself finding that drug overdose deaths involving prescription opioids rose from 3,442 in 1999 to 17,029 in 2017, there has only ever been an increasing demand to create sustainable pathways out of opioid addiction.

Elsewhere in the field of combatting addictions across the US, stimulants have caught the attention of researchers as they similarly look to set up trials to deal with a rising problem across the US.