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reSET-O

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.

reSET

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.