FDA clears mobile app to curb opioid abuse | mHealth technology

mobile app to curb opioid abuse

Mobile app to curb opioid abuse

US agency FDA clears the mobile medical app reSET-O to help the individuals with opioid abuse problem to stay in recovery treatment programs.

Recently, the US Food and Drug Administration gave clearance to a reSET-O, mobile-based medical application, in order to help increase retention of patients going through outpatient treatment for opioid use disorder. The reSET-O app is a prescription cognitive behavioural therapy designed to be used along with other outpatient treatments under the observation of a healthcare professional, in tandem with treatment that consists of buprenorphine and contingency management.

Indeed, the US President Donald Trump has declared the opioid addiction crisis as a matter of public health emergency as just last year over 72,000 Americans died due to drug overdose along with illegal drugs and prescription opioids.

In addition, the FDA has taken many steps to accelerate the process of approving alternate options to get a control over substance abuse problem.

FDA Commissioner Scott Gottlieb, M.D said that the agency is mainly focusing on new tools and therapies like mobile health apps in order to aid more people with opioid use disorder overcome their addiction. Earlier this year, in order to promote the development of medical devices to help with successful treatment of addiction, FDA launched an innovation challenge.

The FDA agency has recently chosen eight medical device makers, together with a virtual reality start-up, from the innovation contest intended to tackle the substance abuse crisis. The FDA provided the clearance of the reSET-O device to Pear Therapeutics.

How does reset-O work?

A patient can directly download the reSET-O app to his or her mobile device after receiving a prescription to do so from the consulting doctor. It has been intended to be used when patients are participating in an outpatient opioid use disorder (OUD) treatment program. Patients and healthcare professionals can use this app for training, monitoring and as a reminder tool in order to maintain the success of an outpatient treatment program. The app comprises a compliance reward system, for instance, earning special icons on a prize wheel inside the app.

The FDA studied data from a multi-site, unblinded, controlled 12-week clinical trial of 170 patients who were given buprenorphine treatment together with a behaviour therapy program under a strict supervision. It was done with and without the addition of a desktop-version of reSET-O, which was accessible at the clinic. Patients were given buprenorphine, and urine screening was done three times per week. They also participated in a contingency management system to recompense negative urine tests.

There was a noteworthy increase in the retention of patients in the treatment program for 12 weeks while they were using the reSET-O app, as compared to those who did not use this app.

The retention rate for those who used the reSET-O app for 12 weeks was 82.4 percent, and for those who did not use the app, the retention rate was 68.4 percent. The research data also showed that there were no side effects with the use of the program in the trial. In addition, the app should not be used as a separate therapy, as a substitute for medicine, and by the patients who do not understand English.

Image credit: play.google.com

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