Opioid addiction remains a disturbing problem in the United States. Many theories have been proposed and programs developed in the hopes of reducing the epidemic. The U.S. Food and Drug Administration recently approved a mobile app known as reSET-O, which is designed to enable opioid abusers to maintain sobriety as part of an outpatient treatment program.
During the first six months of 2017, more than 66,000 people became victims of drug overdoses that resulted in fatalities. In the same year, approximately 1.9 million people suffered nonfatal overdoses after abusing opiates. The largest increase in the number of overdoses occurred in Delaware, New Jersey, Ohio, Pennsylvania and Washington D.C. It’s estimated that more than 20 million people in the United States are addicted to opioid medications.
The app will be made available by prescription and provides cognitive behavior therapy online. Clients using the app will also receive transmucosal buprenorphine treatment. The therapy plan requires that clients must be 18 years of age or older. They must additionally stay under the direct supervision of a qualified medical practitioner.
After receiving the prescription, patients may then download the reSET-O app on a smartphone or other mobile device. The app provides users with a reward system in which clients earn icons from a prize wheel. The software additionally enables patients to report personal data that may include cravings, buprenorphine use and addiction triggers.
Dr. Corey McCann, the CEO and president of Pear Therapeutics, explains that given the current addiction statistics, new therapies are needed to address the problem. The FDA-approved app provides a new method of helping opioid abusers deal with their addiction when used in combination with medication.
The reSET-O was approved via the 501(k) pathway. The program enables companies to gain approval of a device that is demonstrated as being similar to previous versions. The FDA approved the app following data submitted from a 12-week trial involving 170 volunteers. Half of the group were prescribed buprenorphine in combination with the reSET-O app. The control group received the medication alone. All participated in the study while under the direct supervision of clinicians. They also submitted to three urine samples each week. Following the 12 weeks, 82.4 percent of the reSET-O group maintained sobriety compared to 68.4 percent in the control group.