The FDA has cleared a mobile medical application (app) in an effort to increase retention in outpatient treatment programs for individuals with opioid use disorder (OUD). Pear Therapeutics’ ReSET-O app is a prescription cognitive behavioral therapy for use in addition to outpatient treatment under the care of a health care professional, in conjunction with treatment with buprenorphine and contingency management.
Patients sometimes find their commitment to staying in treatment may wane. Medical devices, including mobile medical apps, can play a unique and important role in helping them comply with treatment regimens. Providing OUD patients with more options and proper support to address their treatment challenges is key to helping them succeed.
ReSET-O can be downloaded to a patient’s mobile device after he or she receives a doctor’s prescription. It is intended to be used while participating in an outpatient OUD treatment program, and can serve as a training, monitoring, and reminder tool for health care providers and patients.
ReSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD. Data from clinical studies did not indicate any side effects associated with use of the program used in the trial. The adverse events evaluated were typical of patients with OUD, including cardiovascular disease, gastrointestinal diseases, HIV, hepatitis C, nutrition-related diseases, risk of overdose, depression, mania, and suicidal behavior, ideation, and attempts.
The app is not intended to be used as a stand-alone therapy, a substitute for medication, or for patients whose main language is not English.
Source: FDA, December 10, 2018