Recovery is a 24/7 process. Treatment should be too.

reSET®, for substance use disorder, is a 12-week, FDA-authorized prescription digital therapeutic (PDT) clinically proven to help people in outpatient treatment abstain from substance use and stay in treatment longer.1,2

reSET-O®, for opioid use disorder, is a 12-week, FDA-authorized prescription digital therapeutic (PDT) clinically proven to help people in outpatient treatment and on transmucosal buprenorphine stay in their treatment longer.3,4

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Stay on track

Substance and opioid use disorders are chronic, treatable diseases. And yet, of the millions of Americans who struggle each year with these forms of addiction, most never get help. If youre among the 20% who found treatment for opioid or substance use disorders, you may be ready for what’s next.5-7

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You’re not alone

See how individuals in outpatient therapy are using our treatments, anytime, anywhere, to build skills and stay connected with their doctors and therapists in between appointments.

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We’re here to help

PearConnect™ is all about you and your recovery journey. From benefits investigation services and help determining copay assistance eligibility to technical support, your dedicated PearConnect patient specialist will be there for you.

reSET® 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.

reSET® 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 with a reading level of 7th grade or above, who have access to an Android/iOS tablet or smartphone, and who 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 is not intended to be used as stand-alone therapy for substance use disorder (SUD) and does not replace care by your provider or outpatient treatment. 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 reporting opioids as their primary substance of abuse.

Please see the Patient Brief Summary Instructions for reSET.

reSET-O® 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.

reSET-O® 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 with a reading level of 7th grade or above, who have access to an Android/iOS tablet or smartphone, and who 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 is not intended to be used as stand-alone therapy for Opioid Use Disorder (OUD) and does not replace care by your provider or outpatient treatment. 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.

References:

1. 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

2. reSET Clinician directions for use. Pear Therapeutics, Inc. 2020.

3. 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

4. reSET-O Clinician directions for use. Pear Therapeutics, Inc. 2020.

5. Definition of Addiction. ASAM. Accessed April 30, 2020. https://www.asam.org/Quality-Science/definition-of-addiction

6. Substance Abuse and Mental Health Services Administration. 2019. Key substance use and mental health Indicators In the United States: results from the 2018 National Survey on Drug Use and Health (HHS Publication No. PEPI9-5068, NSDUH Series H-54). Rockville, MD: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Administration. Retrieved from https://www.samhsa.gov/data/

7. McCance-Katz EF. SAMHS/HHS: An Update on the Opioid Crisis. Presented at: AATOD Conference. March 12-14, 2018; New York, NY. Accessed June 10, 2020.

Pear Therapeutics is excited to announce new coverage from MassHealth

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