Substance abuse treatment is now as close as your mobile device. Previously, “treatment as usual” (TAU) consisted of face-to-face counseling. A sub-group of patients in the study, those who weren’t abstinent at the start, showed an almost five-fold improvement. The Substance Abuse and Mental Health Services Administration said an estimated 20.1 million people 12 or older needed substance use treatment in 2016. Abuse of and addiction to alcohol, nicotine, and illicit and prescription drugs cost Americans more than $700 billion a year. That’s in increased health care costs, crime and lost productivity. It also contributed to the death of more than 90,000 Americans.
In September, the U.S. Food and Drug Administration approved Pear Therapeutics’ request to market reSET for outpatient treatment of substance abuse. It was the first time the FDA cleared a prescription digital therapeutic with claims to improve outcomes in a disease. Patients download the application on their mobile devices. The product is activated with a prescription access code provided by doctors or medical providers. Treatment – using neurobehavioral therapy – and progress are monitored from a remote clinician dashboard. There, medical providers access patients’ self-reported substance use, triggers, cravings and outcomes. reSET is intended for patients 18 and older who are currently enrolled in outpatient treatment under the supervision of a clinician. The therapeutic can be used for treatment of use related to stimulants, cannabis, cocaine and alcohol. A national 12-week clinical trial found the digital therapeutic reSET, used with reduced face-to-face counseling, more than doubled the rate of abstinence. And now the FDA has cleared the system for treating opioid addiction as well.
“Prescription digital therapeutics hold promise in improving patient outcomes across a wide range of central nervous system disorders including psychiatry, neurology and pain,” according Corey McCann, Pear’s president and chief executive officer. “Clinically validated digital therapeutics may become a cornerstone of future treatment,” said Dr. Edward V. Nunes, professor of psychiatry at Columbia University Medical Center and independent lead investigator on the clinical study.
