One reason the opioid addiction epidemic has taken hold in many rural areas is that many Americans with substance use disorder live long distances from the nearest treatment providers.
But a new tool may provide hope. The U.S Food and Drug Administration (FDA) is currently reviewing a new tool designed to bridge that geographical distance: the first prescription digital therapy designed to treat SUD.
Boston and San Francisco-based Pear Therapeutics developed reSET, a mobile app used as a treatment tool concurrently with outpatient therapy centered on SUDs.
The project has demonstrated better abstinence and treatment retention when applied alongside face-to-face therapy focused on SUD-related treatments for alcohol, marijuana, cocaine and stimulants. The therapy also includes a web-based program for health care providers.
Pear is also developing ReSET-0, an app specifically designed to help opiate addicts. Both apps consist of a patient-facing smartphone application and a clinician-facing web interface.
The company raised $20 million last year with the aid of various venture companies including Arboretum Ventures, an Ann Arbor, Mich.-based venture capital firm.
“(reSET) will give patients and clinicians a new tool to improve therapy specifically in an area right now that has a true health epidemic in the U.S,” Dr. Thomas Shehab, managing director at Arboretum Ventures, told DrugAddictionNow.com. “It’s an extremely novel approach to central nervous system and behavioral health diseases that we didn’t see anyone else addressing in that way.”
Pear submitted ReSET for review by the FDA during the first half of 2016 and says it is expected to be approved this year.
Dr. Shehab said his firm is “particularly intrigued by their approach because it’s a combination of a very well studied digital therapy being used in conjunction with other therapies,” Dr. Shehab said. “We thought the unique makeup of the Pear team and their unique approach to digital therapies really made us feel it had the highest likelihood of success in really helping regress these issues.”
According to data provided by Pear Therapeutics, 507 people with SUD from 10 treatment centers nationally received either face-to-face therapy or reduced volume of face-to-face therapy with reSET. They were given 12 weeks of outpatient therapy with or without using the app; if without, a portion of the digital therapy was replaced with face-to-face therapy.
Abstinence was calculated two times weekly through a breathalyzer, urine samples and self-reports. Of the participants dependent on alcohol, marijuana, cocaine and stimulants, 58.1 percent of them receiving treatment with reSET were abstinent during week nine through 12, versus 29.8 percent of participants receiving only face-to-face therapy.
Of the participants who started the study with a positive drug test, 26.7 percent of them who received reSET were abstinent during weeks nine through 12 of the study; only 3.2 percent of those that received traditional face-to-face therapy reported abstinence during the same time period.
Participants using reSET presented statistically significant advancement in retention rates compared to those not using the app. After 12 weeks, 59 percent of participants that received face-to-face therapy retained sobriety in comparison to the 67 percent of those that used reSET.
The ReSET-O app has shown promising results in three independent and randomized clinical trials, the company says.
A study of 465 participants that completed outpatient methadone or buprenorphine treatment for opioid addiction was conducted, in which the participants were given standardized face-to-face therapy or shortened standardized treatment with reSET-O. Their abstinence was determined by self-reporting and urine tests.
The developers plan to submit reSET-O to the FDA for approval, pending approval of reSET.
“This is a very exciting company that we’re very enthusiastic about because it benefits a group of patients in great need,” Dr. Shehab said. “We think that reSET has a lot of potential.”
In July Pear announced it has received a Small Business Innovation Research (SBIR) Fast-Track award funded by the National Institute on Drug Abuse (NIDA).
PEAR will collaborate on the project with CleanSlate Research and Education Foundation and Columbia University Medical Center Department of Psychiatry’s Division on Substance Use Disorders on the project. The grant will support the application of “enhanced engagement and gamification mechanisms” to reSET and reSET-O, the company says.
Gamification is the application of typical elements of game playing, such as point scoring, competition with others, and rules of play.