PursueCare RESET-O® 1.16.0

Recovery is a challenging and ongoing process, especially in the periods between therapy sessions when access to a counselor or doctor might not be readily available. RESET-O® is a Prescription Digital Therapeutic, a novel form of therapy prescribed by doctors to aid in treatment. It operates alongside buprenorphine medication-assisted therapy (MAT), allowing individuals to continue their recovery efforts on their smartphones or tablets, facilitating the development of new skills and offering support at any time, from anywhere.

RESET-O® is a 12-week prescription digital therapeutic tailored for outpatient opioid use disorder patients undergoing treatment. It incorporates cognitive behavioral therapy as a supplementary element to outpatient care including transmucosal buprenorphine and contingency management. It is specifically targeted towards patients currently under clinical supervision. RESET-O® stands out as the sole FDA-authorized prescription digital therapeutic clinically proven to enhance treatment retention rates for individuals with opioid use disorder.

Important Safety Information

• Warnings/precautions: Do not utilize RESET-O® for communicating emergency, urgent, or critical information, as it lacks features for sending such alerts to your clinician. In case of self-harm or harm to others, contact 911 or visit the nearest emergency facility. RESET-O® targets English or Spanish-speaking patients with access to compatible smartphones or tablets and an understanding of mobile applications. Periodic data uploads are necessary, requiring internet or wireless connectivity. To begin using RESET-O®, a unique user name and password are mandatory, which should not be shared with others. The app may transmit protected health information and/or personally identifiable data. RESET-O® is designed as an adjunct, not standalone therapy for Opioid Use Disorder (OUD), hence does not replace professional care. It does not substitute medications; patients should adhere to their provider's directions.
• The prolonged efficacy of RESET-O® has not been assessed in studies surpassing 12 weeks (84 days) among the OUD population. Its ability to prevent potential relapse post-therapy cessation has not been examined. Refer to the Patient Brief Summary Instructions within the app for more details.

1. 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.

2. RESET-O® Patient directions for Use. PursueCare, 2024.