reSET-O is a 12-week, Prescription Digital Therapeutic you can use together with your buprenorphine in outpatient treatment for opioid use disorder. It uses a secure, convenient mobile app for anytime, anywhere access to features clinically proven to help increase your chances for success.1
reSET-O is the only FDA-authorized prescription digital therapeutic that’s clinically-proven to help people with opioid use disorder stay in treatment longer.1,2 It allows you to continue the work you’re doing in outpatient therapy on your smartphone or tablet, in between appointments, when you normally can’t access a counselor or doctor, but still want to practice new skills or get support.
reSET® is the first FDA-authorized prescription digital therapeutic that’s proven to help people with substance use disorder double the likelihood of abstinence from use and stay in treatment longer.3,4 reSET gives you anytime, anywhere access to features that can help increase your chances for success in treatment. It allows you to continue the work of treatment on your smartphone or tablet, in between appointments, when you normally can’t access a counselor or doctor, but still want to practice new skills or get support.
PearConnect™ is all about you and your recovery journey. From help determining insurance coverage and benefits to copay assistance eligibility and technical support, your dedicated PearConnect patient specialist knows how to help.
Indications for Use:
reSET-O prescription digital therapeutic is a 12-week (84 day) software application intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatient treatment that includes transmucosal buprenorphine and contingency management, for patients 18 years or older who are currently under the supervision of a clinician. reSET-O is indicated as a prescription-only digital therapeutic.
Important Safety Information for Patients:
Warnings/precautions: Do not use reSET-O to communicate any emergency, urgent or critical information. reSET-O does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
reSET-O is intended for patients whose primary language is English, who have access to an Android/iOS tablet or smartphone and are familiar with the use of smartphone applications (apps). You should be able to upload data periodically, i.e. have internet/wireless connection access.
reSET-O requires you to enter a user name and password prior to use. Please do not share your user name and password with others. reSET-O may contain and transmit protected health information and/or personally identifiable information.
reSET-O is not intended to be used as stand-alone therapy for Opioid Use Disorder (OUD) and does not replace care by your provider. reSET-O is not a substitute for your medications. You should continue to take your medications as directed by your provider.
The long-term benefit of reSET-O has not been evaluated in studies lasting beyond 12 weeks (84 days) in the OUD population. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
Please see the Patient Brief Summary Instructions for reSET-O.
Indications for Use:
reSET is intended to provide cognitive behavioral therapy, as an adjunct to a contingency management system, for patients 18 years of age and older, who are currently enrolled in outpatient treatment under the supervision of a clinician. reSET is indicated as a 12-week (90 day) prescription-only treatment for patients with substance use disorder (SUD), who are not currently on opioid replacement therapy, who do not abuse alcohol solely, or who do not abuse opioids as their primary substance of abuse.
It is intended to:
• increase abstinence from a patient’s substances of abuse during treatment, and
• increase retention in the outpatient treatment program.
Important Safety Information for Patients:
Warnings/precautions: Do not use reSET to communicate any emergency, urgent or critical information. reSET does not include features that can send alerts or warnings to your clinician. If you have feelings or thoughts of harming yourself or others, please dial 911 or go to the nearest emergency room.
reSET is intended for patients whose primary language is English, who have access to an Android/iOS tablet or smartphone and are familiar with the use of smartphone applications (apps). You should be able to upload data periodically, i.e. have internet/wireless connection access.
reSET requires you to enter a user name and password prior to use. Please do not share your user name and password with others. reSET may contain and transmit protected health information and/or personally identifiable information.
reSET is not intended to be used as stand-alone therapy for substance use disorder (SUD) and does not replace care by your provider. reSET is not a substitute for your medications. You should continue to take your medications as directed by your provider.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12 weeks (90 days) in the SUD population. The ability of reSET to prevent potential relapse after treatment discontinuation has not been studied. The safety and effectiveness of reSET has not been established in patients enrolled in opioid treatment programs.
Please see the Patient Brief Summary Instructions for reSET.
References:
1. reSET-O Clinician directions for use. Pear Therapeutics, Inc. 2020.
2. FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs. News release. Silver Spring, MD: US Food and Drug Administration. December 10, 2018. Accessed May 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-clears-mobile-medical-app-help-those-opioid-use-disorder-stay-recovery-programs
3. reSET Clinician directions for use. Pear Therapeutics, Inc. 2020.
4. FDA permits marketing of mobile medical application for substance use disorder. News release. Silver Spring, MD: US Food and Drug Administration. September 14, 2017. Accessed May 18, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-mobile-medical-application-substance-use-disorder
