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Indications for Use:reSET-O is 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:Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on back cover and accompanying Clinician Brief Summary Instructions on inside pages.
Please see accompanying Clinician Brief Summary Instructions on pages on reverse side.
© 2019 Sandoz Inc. All rights reserved. reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners. D-RSO-1373196 04/2019
References: 1. National Institute on Drug Abuse. Opioid overdose crisis. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis. Updated January 2019. Accessed March 15, 2019. 2. Centers for Disease Control and Prevention. Understanding the Epidemic. https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 20, 2019. 3. Council of Economic Advisers Report: the Underestimated Cost of the Opioid Crisis [news release]. Washington, DC: Executive O� ce of the President of the United States. Council of Economic Advisers. November 20, 2017. https://www.whitehouse.gov/briefi ngs-statements/cea-report-underestimated-cost-opioid-crisis/. Accessed April 5, 2019. 4. Data on fi le. reSET & reSET-O Symphony Data Analysis Compendium. Patient/HCP/Payor Insights: A Compendium Based on SHS Data. February 2019. 5. Huhn AS, Dunn KE. Why aren’t physicians prescribing more buprenorphine? J Subst Abuse Treat. 2017;78:1-7. 6. Hutchinson E, Catlin M, Andrillas CHA, et al. Barriers to primary care physicians prescribing buprenorphine. Ann Fam Med. 2014;12(2):128-133. 7. Center for Substance Abuse Treatment. Substance Abuse: Clinical Issues in Intensive Outpatient Treatment. Treatment Improvement Protocol (TIP) Series 47. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006. Intensive Outpatient Treatment and the Continuum of Care. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006. 8. Hser Y-I, Saxon AJ, Huang D, et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2013;109(1):79-87. 9. U.S. Department of Health and Human Services (HHS), O� ce of the Surgeon General, Facing Addiction in America: The Surgeon General’s Spotlight on Opioids. Washington, DC: HHS, September 2018. https://www.addiction.surgeongeneral.gov/sites/default/fi les/OC_SpotlightOnOpioids.pdf. Accessed April 5, 2019. 10. Substance Abuse and Mental Health Services Administration. O� ce of the Surgeon General. Facing Addiction in America. Washington, DC: US Dept of Health and Human Services; September 2018. https://www.addiction.surgeongeneral.gov. Accessed April 5, 2019. 11. reSET-O Clinician directions for use (LBL006.E – 2019-01-16). Pear Therapeutics, Inc.; 2018.
Two study groups were:TAU=buprenorphine + clinician visits + contingency managementTES=buprenorphine + clinician visits + contingency management + reSET-O
Ask your Sandoz Digital Therapeutics Specialist to show you a product demonstration
IMPROVE THE IMPACT OF YOUR OUD PATIENT THERAPY WITH reSET-O™11
CLINICALLY VALIDATED TO INCREASE RETENTIONof patients with OUD in outpatient treatment (TES, 82.4%; TAU, 68.4%; P=0.0224)11
For questions and technical support, contact your reSET ConnectTM Patient Service Center Call: 1-833-MY RESET (1-833-697-3738), Monday–Friday, 8 AM–6 PM ET
TRACK PATIENT-REPORTED BUPRENORPHINE CHECK-INSthat support patients’ current therapy regimens and facilitate transparency in patient-clinician dialogue11
IMPROVES THE IMPACT OF OUTPATIENT OUD THERAPYby providing 24/7 access to cognitive behavioral therapy, contingency management, and fl uency training11
TRACKS MEASURABLE RESULTSthat help you focus on patients’ progress to make face-to-face meetings more meaningful11
Visit www.reSETforRecovery.com
CLINICALLY VALIDATED TO INCREASE RETENTION of patients with OUD in outpatient treatment (TES, 82.4%; TAU, 68.4%; P=0.0224)11
MEETS MAT REQUIREMENTS FOR OUTPATIENT BEHAVIORAL THERAPY with evidence-based and consistent delivery of cognitive behavioral therapy, contingency management, and fluency training9,11
FOSTERS GREATER ENGAGEMENT AND ACCESS with interactive modules whose therapeutic content is available via patients’ smartphone or tablet11
THE 24/7 ACCESS TO reSET-O™ CAN CHANGE EVERYTHING11
GAIN DEEPER INSIGHTS INTO YOUR PATIENTS’ PROGRESS TOWARD RECOVERY WITH THE CLINICIAN DASHBOARD11
View patient summary, personal information, prescription status, clinician-entered drug screen results, and appointment attendance
Follow patient-reported buprenorphine check-ins, substance use, cravings and triggers, as well as lesson completion
See the severity and intensity of patient-reported cravings and triggers
Enter drug screen results, to further guide the conversation
HELP CLOSE TREATMENT GAPS WITH A PRESCRIPTION DIGITAL THERAPEUTIC LIKE reSET-O
FOLLOW
SEE
ENTER
VIEWImportant Safety Information:Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
CLINICIAN INFORMATION Brief Summary Instructions
reSET-O™
Prescription Mobile Medical Application
This clinician information leaflet does not include all the information needed to use reSET-O safely and effectively. Pleasesee the full reSET-O Clinician Directions for Use within the reSET-O Clinician Dashboard for complete Important Safety Information.
Important Safety Information: Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD).reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcareprovider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
What is reSET-O? reSET-O is a prescription Mobile Medical Application (MMA) for patients with Opioid Use Disorder. MMAs are software applications used as an accessory to a regulated medical device or transform the mobile platform into a medical device. MMAs are regulated by the U.S. FDA. reSET-O was validated through randomized clinical trials with data to demonstrate its safety and efficacy.2 reSET-O is available by prescription-use only and is intended to provide 12 week (84 days) of cognitive behavioral therapy as an adjunct to contingency management (CM) for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. The reSET-O software uses the patient’s smartphone or tablet to deliver contenton demand as a complement to outpatient treatment.
How to Start Using reSET-O:
The following steps will help guide your use of reSET-O and the Clinician Dashboard correctly:
• A licensed clinician prescribes reSET-O via the enrollment form, which includes an email address for the patient.
• A patient care specialist from reSET Connect™ by Pear Therapeutics, Inc. contacts the patient via telephone with an access code, and guides the patient through downloading the app from the Apple App Store or Google Play Store.
• The patient downloads the applicationand enters the access code and email address from prescription, then sets a password to use for subsequent login in the case of deleting/reinstalling the app, getting a new phone or tablet.
• The patient begins working and learning with reSET-O, completes lessons, answers quiz questions (fluency training), and reports substance use, cravings, and triggers. reSET-O also notifies patients with reminders to take their buprenorphine (note: this feature is voluntary)
• reSET-O includes a CM system that gives the patient a chance to win rewards for lessons completed and negative drug screens achieved duringthe 12-week (84-day) therapy period.
• The clinician receives an email sent to the email address provided on the enrollment form. The email contains alink to verify the account and set a password. Once an account is created,the Clinician Dashboard can be accessed at any time by visitingwww.pear.md.
• Using the Clinician Dashboard, theclinician can monitor the patient’s progress, use of reSET-O app, and view patient-reported substance use, cravings and triggers.
• The clinician can also enter drug screen results and appointment compliance dates using the Clinician Dashboard. Appointment compliance must occur every 30 days or less during the 12-week (84-day) therapy period, as determined by the entries in the Clinician Dashboard. After 30 days, the patient will no longer be able to access their CM rewards via the reSET-O app. Access will be restored after a recent appointment compliance is entered via the Clinician Dashboard.
• The reSET-O software works with outpatient therapy to support the patient’s OUD treatment.
Please see full Clinician Directions for Use(DFU) for complete instructions on how to use the reSET-O Clinician Dashboard and how patients can share information with their clinician using reSET-O.
1 Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496. 2 Date on file. Pear Therapeutics, Inc.
Issued: 12/2018 S-RSO-1368205
What Operating Systems and Browsers Does reSET-O Support? The reSET-O app is supported on the following mobile operating systems:
• iOS 8.0 and above• Android 4.1 and above
The reSET-O Clinician Dashboard is optimized for desktop computer access and is supported on the following web browsers:
• Google Chrome• Firefox• Microsoft Internet Explorer• Microsoft Edge• Safari
General Information about the Safe and Effective Use of reSET-O: Individuals outside active enrollment in an OUD treatment program should not use reSET-O. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET-O is not intended to reduce the amount of face-to-face clinician time. The therapy lesson use tracking data collected by reSET-O is not intended to be used as a stand-alone assessment of therapy progress or for making determinations regarding a patient’s OUD.Treatment decisions should be based on all medical history and data pertaining to a patient. Clinicians should use their best judgment when considering self-reported data about substance use and cravings and seek to verify and validateuse with objective measures such as urine drug screens, Breathalyzer or other laboratory tests.Clinicians should undertake standard of care to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves. reSET-O may contain and transmit protected health information and/or personally identifiableinformation.
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD. Please see the clinical summary section of the DFU for more details on the study design and results.
Please see full Clinician Directions for Use for complete Important Safety Information.
Indications for Use Statement: reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatienttreatment 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 Mobile Medical Application.
Limitations of Use:
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
Additional Information Available:The clinical study summary is available in publication1 and a summary of the clinical study results is available on the FDA website.2
Additional Support Available:For additional support with any aspect of the reSET-O app, you can contact reSET Connect™ via email at [email protected] by phone at 1-833-MY-RESET (1-833-697-3738).
reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners.
Important Safety Information:Warnings: reSET-O™ is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on the back cover and accompanying Clinician Brief Summary Instructions on following pages.
THIS IS THE MOMENT THAT DEMANDS A NEW APPROACH
BARRIERS TO MEDICATION-ASSISTED TREATMENT(MAT) MAY KEEP PROVIDERS FROM PRESCRIBING THE GOLD STANDARD OF TREATMENT5,6
CARE TRANSITIONS ARE CRITICAL MOMENTS FOR PATIENTS WITH OPIOID USE DISORDER7
• REGULATIONS AND RESTRICTIONS CONCERNING THE USE OF MEDICATION-ASSISTED TREATMENT (MAT)5
• LACK OF ACCESS TO PSYCHOSOCIAL RESOURCES FOR PATIENTS6
• TIME CONSTRAINTS 5,6
is the estimated total economic burden of the opioid crisis3
$504BILLION
someone in the US dies from an opioid overdose2,3
11MINUTES
EVERY OF THE
people prescribed a buprenorphine-containing treatment, 1 million did not receive behavioral therapy4
1.1MILLION
OPIOID ABUSE IS A NATIONAL PUBLIC HEALTH EMERGENCY1
THE GOLD STANDARD for treating opioid addiction
is MAT: the use of medications combined
with counseling and behavioral therapies9,10
–O�ce of the Surgeon GeneralREDUCED TOUCHPOINTS
can lead to patient dropout7 TREATMENT RETENTIONis a predictor of favorable treatment outcomes8
CLINICIAN INFORMATION Brief Summary Instructions
reSET-O™
Prescription Mobile Medical Application
This clinician information leaflet does not include all the information needed to use reSET-O safely and effectively. Pleasesee the full reSET-O Clinician Directions for Use within the reSET-O Clinician Dashboard for complete Important Safety Information.
Important Safety Information: Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD).reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcareprovider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
What is reSET-O? reSET-O is a prescription Mobile Medical Application (MMA) for patients with Opioid Use Disorder. MMAs are software applications used as an accessory to a regulated medical device or transform the mobile platform into a medical device. MMAs are regulated by the U.S. FDA. reSET-O was validated through randomized clinical trials with data to demonstrate its safety and efficacy.2 reSET-O is available by prescription-use only and is intended to provide 12 week (84 days) of cognitive behavioral therapy as an adjunct to contingency management (CM) for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. The reSET-O software uses the patient’s smartphone or tablet to deliver contenton demand as a complement to outpatient treatment.
How to Start Using reSET-O:
The following steps will help guide your use of reSET-O and the Clinician Dashboard correctly:
• A licensed clinician prescribes reSET-O via the enrollment form, which includes an email address for the patient.
• A patient care specialist from reSET Connect™ by Pear Therapeutics, Inc. contacts the patient via telephone with an access code, and guides the patient through downloading the app from the Apple App Store or Google Play Store.
• The patient downloads the applicationand enters the access code and email address from prescription, then sets a password to use for subsequent login in the case of deleting/reinstalling the app, getting a new phone or tablet.
• The patient begins working and learning with reSET-O, completes lessons, answers quiz questions (fluency training), and reports substance use, cravings, and triggers. reSET-O also notifies patients with reminders to take their buprenorphine (note: this feature is voluntary)
• reSET-O includes a CM system that gives the patient a chance to win rewards for lessons completed and negative drug screens achieved duringthe 12-week (84-day) therapy period.
• The clinician receives an email sent to the email address provided on the enrollment form. The email contains alink to verify the account and set a password. Once an account is created,the Clinician Dashboard can be accessed at any time by visitingwww.pear.md.
• Using the Clinician Dashboard, theclinician can monitor the patient’s progress, use of reSET-O app, and view patient-reported substance use, cravings and triggers.
• The clinician can also enter drug screen results and appointment compliance dates using the Clinician Dashboard. Appointment compliance must occur every 30 days or less during the 12-week (84-day) therapy period, as determined by the entries in the Clinician Dashboard. After 30 days, the patient will no longer be able to access their CM rewards via the reSET-O app. Access will be restored after a recent appointment compliance is entered via the Clinician Dashboard.
• The reSET-O software works with outpatient therapy to support the patient’s OUD treatment.
Please see full Clinician Directions for Use(DFU) for complete instructions on how to use the reSET-O Clinician Dashboard and how patients can share information with their clinician using reSET-O.
1 Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496. 2 Date on file. Pear Therapeutics, Inc.
Issued: 12/2018 S-RSO-1368205
What Operating Systems and Browsers Does reSET-O Support? The reSET-O app is supported on the following mobile operating systems:
• iOS 8.0 and above• Android 4.1 and above
The reSET-O Clinician Dashboard is optimized for desktop computer access and is supported on the following web browsers:
• Google Chrome• Firefox• Microsoft Internet Explorer• Microsoft Edge• Safari
General Information about the Safe and Effective Use of reSET-O: Individuals outside active enrollment in an OUD treatment program should not use reSET-O. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET-O is not intended to reduce the amount of face-to-face clinician time. The therapy lesson use tracking data collected by reSET-O is not intended to be used as a stand-alone assessment of therapy progress or for making determinations regarding a patient’s OUD.Treatment decisions should be based on all medical history and data pertaining to a patient. Clinicians should use their best judgment when considering self-reported data about substance use and cravings and seek to verify and validateuse with objective measures such as urine drug screens, Breathalyzer or other laboratory tests.Clinicians should undertake standard of care to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves. reSET-O may contain and transmit protected health information and/or personally identifiableinformation.
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD. Please see the clinical summary section of the DFU for more details on the study design and results.
Please see full Clinician Directions for Use for complete Important Safety Information.
Indications for Use Statement: reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatienttreatment 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 Mobile Medical Application.
Limitations of Use:
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
Additional Information Available:The clinical study summary is available in publication1 and a summary of the clinical study results is available on the FDA website.2
Additional Support Available:For additional support with any aspect of the reSET-O app, you can contact reSET Connect™ via email at [email protected] by phone at 1-833-MY-RESET (1-833-697-3738).
reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners.
Important Safety Information:Warnings: reSET-O™ is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on the back cover and accompanying Clinician Brief Summary Instructions on following pages.
THIS IS THE MOMENT THAT DEMANDS A NEW APPROACH
BARRIERS TO MEDICATION-ASSISTED TREATMENT(MAT) MAY KEEP PROVIDERS FROM PRESCRIBING THE GOLD STANDARD OF TREATMENT5,6
CARE TRANSITIONS ARE CRITICAL MOMENTS FOR PATIENTS WITH OPIOID USE DISORDER7
• REGULATIONS AND RESTRICTIONS CONCERNING THE USE OF MEDICATION-ASSISTED TREATMENT (MAT)5
• LACK OF ACCESS TO PSYCHOSOCIAL RESOURCES FOR PATIENTS6
• TIME CONSTRAINTS 5,6
is the estimated total economic burden of the opioid crisis3
$504BILLION
someone in the US dies from an opioid overdose2,3
11MINUTES
EVERY OF THE
people prescribed a buprenorphine-containing treatment, 1 million did not receive behavioral therapy4
1.1MILLION
OPIOID ABUSE IS A NATIONAL PUBLIC HEALTH EMERGENCY1
THE GOLD STANDARD for treating opioid addiction
is MAT: the use of medications combined
with counseling and behavioral therapies9,10
–O�ce of the Surgeon GeneralREDUCED TOUCHPOINTS
can lead to patient dropout7 TREATMENT RETENTIONis a predictor of favorable treatment outcomes8
Indications for Use:reSET-O is 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:Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on back cover and accompanying Clinician Brief Summary Instructions on inside pages.
Please see accompanying Clinician Brief Summary Instructions on pages on reverse side.
© 2019 Sandoz Inc. All rights reserved. reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners. D-RSO-1373196 04/2019
References: 1. National Institute on Drug Abuse. Opioid overdose crisis. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis. Updated January 2019. Accessed March 15, 2019. 2. Centers for Disease Control and Prevention. Understanding the Epidemic. https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 20, 2019. 3. Council of Economic Advisers Report: the Underestimated Cost of the Opioid Crisis [news release]. Washington, DC: Executive O� ce of the President of the United States. Council of Economic Advisers. November 20, 2017. https://www.whitehouse.gov/briefi ngs-statements/cea-report-underestimated-cost-opioid-crisis/. Accessed April 5, 2019. 4. Data on fi le. reSET & reSET-O Symphony Data Analysis Compendium. Patient/HCP/Payor Insights: A Compendium Based on SHS Data. February 2019. 5. Huhn AS, Dunn KE. Why aren’t physicians prescribing more buprenorphine? J Subst Abuse Treat. 2017;78:1-7. 6. Hutchinson E, Catlin M, Andrillas CHA, et al. Barriers to primary care physicians prescribing buprenorphine. Ann Fam Med. 2014;12(2):128-133. 7. Center for Substance Abuse Treatment. Substance Abuse: Clinical Issues in Intensive Outpatient Treatment. Treatment Improvement Protocol (TIP) Series 47. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006. Intensive Outpatient Treatment and the Continuum of Care. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006. 8. Hser Y-I, Saxon AJ, Huang D, et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2013;109(1):79-87. 9. U.S. Department of Health and Human Services (HHS), O� ce of the Surgeon General, Facing Addiction in America: The Surgeon General’s Spotlight on Opioids. Washington, DC: HHS, September 2018. https://www.addiction.surgeongeneral.gov/sites/default/fi les/OC_SpotlightOnOpioids.pdf. Accessed April 5, 2019. 10. Substance Abuse and Mental Health Services Administration. O� ce of the Surgeon General. Facing Addiction in America. Washington, DC: US Dept of Health and Human Services; September 2018. https://www.addiction.surgeongeneral.gov. Accessed April 5, 2019. 11. reSET-O Clinician directions for use (LBL006.E – 2019-01-16). Pear Therapeutics, Inc.; 2018.
Two study groups were:TAU=buprenorphine + clinician visits + contingency managementTES=buprenorphine + clinician visits + contingency management + reSET-O
Ask your Sandoz Digital Therapeutics Specialist to show you a product demonstration
IMPROVE THE IMPACT OF YOUR OUD PATIENT THERAPY WITH reSET-O™11
CLINICALLY VALIDATED TO INCREASE RETENTIONof patients with OUD in outpatient treatment (TES, 82.4%; TAU, 68.4%; P=0.0224)11
For questions and technical support, contact your reSET ConnectTM Patient Service Center Call: 1-833-MY RESET (1-833-697-3738), Monday–Friday, 8 AM–6 PM ET
TRACK PATIENT-REPORTED BUPRENORPHINE CHECK-INSthat support patients’ current therapy regimens and facilitate transparency in patient-clinician dialogue11
IMPROVES THE IMPACT OF OUTPATIENT OUD THERAPYby providing 24/7 access to cognitive behavioral therapy, contingency management, and fl uency training11
TRACKS MEASURABLE RESULTSthat help you focus on patients’ progress to make face-to-face meetings more meaningful11
Visit www.reSETforRecovery.com
CLINICALLY VALIDATED TO INCREASE RETENTION of patients with OUD in outpatient treatment (TES, 82.4%; TAU, 68.4%; P=0.0224)11
MEETS MAT REQUIREMENTS FOR OUTPATIENT BEHAVIORAL THERAPY with evidence-based and consistent delivery of cognitive behavioral therapy, contingency management, and fluency training9,11
FOSTERS GREATER ENGAGEMENT AND ACCESS with interactive modules whose therapeutic content is available via patients’ smartphone or tablet11
THE 24/7 ACCESS TO reSET-O™ CAN CHANGE EVERYTHING11
GAIN DEEPER INSIGHTS INTO YOUR PATIENTS’ PROGRESS TOWARD RECOVERY WITH THE CLINICIAN DASHBOARD11
View patient summary, personal information, prescription status, clinician-entered drug screen results, and appointment attendance
Follow patient-reported buprenorphine check-ins, substance use, cravings and triggers, as well as lesson completion
See the severity and intensity of patient-reported cravings and triggers
Enter drug screen results, to further guide the conversation
HELP CLOSE TREATMENT GAPS WITH A PRESCRIPTION DIGITAL THERAPEUTIC LIKE reSET-O
FOLLOW
SEE
ENTER
VIEWImportant Safety Information:Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
CLINICIAN INFORMATION Brief Summary Instructions
reSET-O™
Prescription Mobile Medical Application
This clinician information leaflet does not include all the information needed to use reSET-O safely and effectively. Pleasesee the full reSET-O Clinician Directions for Use within the reSET-O Clinician Dashboard for complete Important Safety Information.
Important Safety Information: Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD).reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcareprovider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
What is reSET-O? reSET-O is a prescription Mobile Medical Application (MMA) for patients with Opioid Use Disorder. MMAs are software applications used as an accessory to a regulated medical device or transform the mobile platform into a medical device. MMAs are regulated by the U.S. FDA. reSET-O was validated through randomized clinical trials with data to demonstrate its safety and efficacy.2 reSET-O is available by prescription-use only and is intended to provide 12 week (84 days) of cognitive behavioral therapy as an adjunct to contingency management (CM) for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. The reSET-O software uses the patient’s smartphone or tablet to deliver contenton demand as a complement to outpatient treatment.
How to Start Using reSET-O:
The following steps will help guide your use of reSET-O and the Clinician Dashboard correctly:
• A licensed clinician prescribes reSET-O via the enrollment form, which includes an email address for the patient.
• A patient care specialist from reSET Connect™ by Pear Therapeutics, Inc. contacts the patient via telephone with an access code, and guides the patient through downloading the app from the Apple App Store or Google Play Store.
• The patient downloads the applicationand enters the access code and email address from prescription, then sets a password to use for subsequent login in the case of deleting/reinstalling the app, getting a new phone or tablet.
• The patient begins working and learning with reSET-O, completes lessons, answers quiz questions (fluency training), and reports substance use, cravings, and triggers. reSET-O also notifies patients with reminders to take their buprenorphine (note: this feature is voluntary)
• reSET-O includes a CM system that gives the patient a chance to win rewards for lessons completed and negative drug screens achieved duringthe 12-week (84-day) therapy period.
• The clinician receives an email sent to the email address provided on the enrollment form. The email contains alink to verify the account and set a password. Once an account is created,the Clinician Dashboard can be accessed at any time by visitingwww.pear.md.
• Using the Clinician Dashboard, theclinician can monitor the patient’s progress, use of reSET-O app, and view patient-reported substance use, cravings and triggers.
• The clinician can also enter drug screen results and appointment compliance dates using the Clinician Dashboard. Appointment compliance must occur every 30 days or less during the 12-week (84-day) therapy period, as determined by the entries in the Clinician Dashboard. After 30 days, the patient will no longer be able to access their CM rewards via the reSET-O app. Access will be restored after a recent appointment compliance is entered via the Clinician Dashboard.
• The reSET-O software works with outpatient therapy to support the patient’s OUD treatment.
Please see full Clinician Directions for Use(DFU) for complete instructions on how to use the reSET-O Clinician Dashboard and how patients can share information with their clinician using reSET-O.
1 Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496. 2 Date on file. Pear Therapeutics, Inc.
Issued: 12/2018 S-RSO-1368205
What Operating Systems and Browsers Does reSET-O Support? The reSET-O app is supported on the following mobile operating systems:
• iOS 8.0 and above• Android 4.1 and above
The reSET-O Clinician Dashboard is optimized for desktop computer access and is supported on the following web browsers:
• Google Chrome• Firefox• Microsoft Internet Explorer• Microsoft Edge• Safari
General Information about the Safe and Effective Use of reSET-O: Individuals outside active enrollment in an OUD treatment program should not use reSET-O. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET-O is not intended to reduce the amount of face-to-face clinician time. The therapy lesson use tracking data collected by reSET-O is not intended to be used as a stand-alone assessment of therapy progress or for making determinations regarding a patient’s OUD.Treatment decisions should be based on all medical history and data pertaining to a patient. Clinicians should use their best judgment when considering self-reported data about substance use and cravings and seek to verify and validateuse with objective measures such as urine drug screens, Breathalyzer or other laboratory tests.Clinicians should undertake standard of care to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves. reSET-O may contain and transmit protected health information and/or personally identifiableinformation.
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD. Please see the clinical summary section of the DFU for more details on the study design and results.
Please see full Clinician Directions for Use for complete Important Safety Information.
Indications for Use Statement: reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatienttreatment 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 Mobile Medical Application.
Limitations of Use:
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
Additional Information Available:The clinical study summary is available in publication1 and a summary of the clinical study results is available on the FDA website.2
Additional Support Available:For additional support with any aspect of the reSET-O app, you can contact reSET Connect™ via email at [email protected] by phone at 1-833-MY-RESET (1-833-697-3738).
reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners.
Important Safety Information:Warnings: reSET-O™ is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on the back cover and accompanying Clinician Brief Summary Instructions on following pages.
THIS IS THE MOMENT THAT DEMANDS A NEW APPROACH
BARRIERS TO MEDICATION-ASSISTED TREATMENT(MAT) MAY KEEP PROVIDERS FROM PRESCRIBING THE GOLD STANDARD OF TREATMENT5,6
CARE TRANSITIONS ARE CRITICAL MOMENTS FOR PATIENTS WITH OPIOID USE DISORDER7
• REGULATIONS AND RESTRICTIONS CONCERNING THE USE OF MEDICATION-ASSISTED TREATMENT (MAT)5
• LACK OF ACCESS TO PSYCHOSOCIAL RESOURCES FOR PATIENTS6
• TIME CONSTRAINTS 5,6
is the estimated total economic burden of the opioid crisis3
$504BILLION
someone in the US dies from an opioid overdose2,3
11MINUTES
EVERY OF THE
people prescribed a buprenorphine-containing treatment, 1 million did not receive behavioral therapy4
1.1MILLION
OPIOID ABUSE IS A NATIONAL PUBLIC HEALTH EMERGENCY1
THE GOLD STANDARD for treating opioid addiction
is MAT: the use of medications combined
with counseling and behavioral therapies9,10
–O�ce of the Surgeon GeneralREDUCED TOUCHPOINTS
can lead to patient dropout7 TREATMENT RETENTIONis a predictor of favorable treatment outcomes8
CLINICIAN INFORMATION Brief Summary Instructions
reSET-O™
Prescription Mobile Medical Application
This clinician information leaflet does not include all the information needed to use reSET-O safely and effectively. Pleasesee the full reSET-O Clinician Directions for Use within the reSET-O Clinician Dashboard for complete Important Safety Information.
Important Safety Information: Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD).reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcareprovider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.
What is reSET-O? reSET-O is a prescription Mobile Medical Application (MMA) for patients with Opioid Use Disorder. MMAs are software applications used as an accessory to a regulated medical device or transform the mobile platform into a medical device. MMAs are regulated by the U.S. FDA. reSET-O was validated through randomized clinical trials with data to demonstrate its safety and efficacy.2 reSET-O is available by prescription-use only and is intended to provide 12 week (84 days) of cognitive behavioral therapy as an adjunct to contingency management (CM) for patients 18 years of age and older who are currently enrolled in outpatient treatment under the supervision of a clinician. The reSET-O software uses the patient’s smartphone or tablet to deliver contenton demand as a complement to outpatient treatment.
How to Start Using reSET-O:
The following steps will help guide your use of reSET-O and the Clinician Dashboard correctly:
• A licensed clinician prescribes reSET-O via the enrollment form, which includes an email address for the patient.
• A patient care specialist from reSET Connect™ by Pear Therapeutics, Inc. contacts the patient via telephone with an access code, and guides the patient through downloading the app from the Apple App Store or Google Play Store.
• The patient downloads the applicationand enters the access code and email address from prescription, then sets a password to use for subsequent login in the case of deleting/reinstalling the app, getting a new phone or tablet.
• The patient begins working and learning with reSET-O, completes lessons, answers quiz questions (fluency training), and reports substance use, cravings, and triggers. reSET-O also notifies patients with reminders to take their buprenorphine (note: this feature is voluntary)
• reSET-O includes a CM system that gives the patient a chance to win rewards for lessons completed and negative drug screens achieved duringthe 12-week (84-day) therapy period.
• The clinician receives an email sent to the email address provided on the enrollment form. The email contains alink to verify the account and set a password. Once an account is created,the Clinician Dashboard can be accessed at any time by visitingwww.pear.md.
• Using the Clinician Dashboard, theclinician can monitor the patient’s progress, use of reSET-O app, and view patient-reported substance use, cravings and triggers.
• The clinician can also enter drug screen results and appointment compliance dates using the Clinician Dashboard. Appointment compliance must occur every 30 days or less during the 12-week (84-day) therapy period, as determined by the entries in the Clinician Dashboard. After 30 days, the patient will no longer be able to access their CM rewards via the reSET-O app. Access will be restored after a recent appointment compliance is entered via the Clinician Dashboard.
• The reSET-O software works with outpatient therapy to support the patient’s OUD treatment.
Please see full Clinician Directions for Use(DFU) for complete instructions on how to use the reSET-O Clinician Dashboard and how patients can share information with their clinician using reSET-O.
1 Christensen DR, Landes RD, Jackson L, et al. Adding an Internet-delivered treatment to an efficacious treatment package for opioid dependence. J Consult Clin Psychol. 2014;82(6):964-972. doi:10.1037/a0037496. 2 Date on file. Pear Therapeutics, Inc.
Issued: 12/2018 S-RSO-1368205
What Operating Systems and Browsers Does reSET-O Support? The reSET-O app is supported on the following mobile operating systems:
• iOS 8.0 and above• Android 4.1 and above
The reSET-O Clinician Dashboard is optimized for desktop computer access and is supported on the following web browsers:
• Google Chrome• Firefox• Microsoft Internet Explorer• Microsoft Edge• Safari
General Information about the Safe and Effective Use of reSET-O: Individuals outside active enrollment in an OUD treatment program should not use reSET-O. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET-O is not intended to reduce the amount of face-to-face clinician time. The therapy lesson use tracking data collected by reSET-O is not intended to be used as a stand-alone assessment of therapy progress or for making determinations regarding a patient’s OUD.Treatment decisions should be based on all medical history and data pertaining to a patient. Clinicians should use their best judgment when considering self-reported data about substance use and cravings and seek to verify and validateuse with objective measures such as urine drug screens, Breathalyzer or other laboratory tests.Clinicians should undertake standard of care to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves. reSET-O may contain and transmit protected health information and/or personally identifiableinformation.
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD. Please see the clinical summary section of the DFU for more details on the study design and results.
Please see full Clinician Directions for Use for complete Important Safety Information.
Indications for Use Statement: reSET-O is intended to increase retention of patients with opioid use disorder (OUD) in outpatient treatment by providing cognitive behavioral therapy, as an adjunct to outpatienttreatment 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 Mobile Medical Application.
Limitations of Use:
reSET-O has not been shown to decrease illicit drug use or improve abstinence in patients with OUD.
Additional Information Available:The clinical study summary is available in publication1 and a summary of the clinical study results is available on the FDA website.2
Additional Support Available:For additional support with any aspect of the reSET-O app, you can contact reSET Connect™ via email at [email protected] by phone at 1-833-MY-RESET (1-833-697-3738).
reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners.
Important Safety Information:Warnings: reSET-O™ is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on the back cover and accompanying Clinician Brief Summary Instructions on following pages.
THIS IS THE MOMENT THAT DEMANDS A NEW APPROACH
BARRIERS TO MEDICATION-ASSISTED TREATMENT(MAT) MAY KEEP PROVIDERS FROM PRESCRIBING THE GOLD STANDARD OF TREATMENT5,6
CARE TRANSITIONS ARE CRITICAL MOMENTS FOR PATIENTS WITH OPIOID USE DISORDER7
• REGULATIONS AND RESTRICTIONS CONCERNING THE USE OF MEDICATION-ASSISTED TREATMENT (MAT)5
• LACK OF ACCESS TO PSYCHOSOCIAL RESOURCES FOR PATIENTS6
• TIME CONSTRAINTS 5,6
is the estimated total economic burden of the opioid crisis3
$504BILLION
someone in the US dies from an opioid overdose2,3
11MINUTES
EVERY OF THE
people prescribed a buprenorphine-containing treatment, 1 million did not receive behavioral therapy4
1.1MILLION
OPIOID ABUSE IS A NATIONAL PUBLIC HEALTH EMERGENCY1
THE GOLD STANDARD for treating opioid addiction
is MAT: the use of medications combined
with counseling and behavioral therapies9,10
–O�ce of the Surgeon GeneralREDUCED TOUCHPOINTS
can lead to patient dropout7 TREATMENT RETENTIONis a predictor of favorable treatment outcomes8
Indications for Use:reSET-O is 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:Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Please see additional Important Safety Information on back cover and accompanying Clinician Brief Summary Instructions on inside pages.
Please see accompanying Clinician Brief Summary Instructions on pages on reverse side.
© 2019 Sandoz Inc. All rights reserved. reSET-O, reSET Connect, Pear Therapeutics, and Sandoz trademarks are the property of their respective owners. D-RSO-1373196 04/2019
References: 1. National Institute on Drug Abuse. Opioid overdose crisis. https://www.drugabuse.gov/drugs-abuse/opioids/opioid-overdose-crisis. Updated January 2019. Accessed March 15, 2019. 2. Centers for Disease Control and Prevention. Understanding the Epidemic. https://www.cdc.gov/drugoverdose/epidemic/index.html. Accessed March 20, 2019. 3. Council of Economic Advisers Report: the Underestimated Cost of the Opioid Crisis [news release]. Washington, DC: Executive O� ce of the President of the United States. Council of Economic Advisers. November 20, 2017. https://www.whitehouse.gov/briefi ngs-statements/cea-report-underestimated-cost-opioid-crisis/. Accessed April 5, 2019. 4. Data on fi le. reSET & reSET-O Symphony Data Analysis Compendium. Patient/HCP/Payor Insights: A Compendium Based on SHS Data. February 2019. 5. Huhn AS, Dunn KE. Why aren’t physicians prescribing more buprenorphine? J Subst Abuse Treat. 2017;78:1-7. 6. Hutchinson E, Catlin M, Andrillas CHA, et al. Barriers to primary care physicians prescribing buprenorphine. Ann Fam Med. 2014;12(2):128-133. 7. Center for Substance Abuse Treatment. Substance Abuse: Clinical Issues in Intensive Outpatient Treatment. Treatment Improvement Protocol (TIP) Series 47. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006. Intensive Outpatient Treatment and the Continuum of Care. DHHS Publication No. (SMA) 06-4182. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2006. 8. Hser Y-I, Saxon AJ, Huang D, et al. Treatment retention among patients randomized to buprenorphine/naloxone compared to methadone in a multi-site trial. Addiction. 2013;109(1):79-87. 9. U.S. Department of Health and Human Services (HHS), O� ce of the Surgeon General, Facing Addiction in America: The Surgeon General’s Spotlight on Opioids. Washington, DC: HHS, September 2018. https://www.addiction.surgeongeneral.gov/sites/default/fi les/OC_SpotlightOnOpioids.pdf. Accessed April 5, 2019. 10. Substance Abuse and Mental Health Services Administration. O� ce of the Surgeon General. Facing Addiction in America. Washington, DC: US Dept of Health and Human Services; September 2018. https://www.addiction.surgeongeneral.gov. Accessed April 5, 2019. 11. reSET-O Clinician directions for use (LBL006.E – 2019-01-16). Pear Therapeutics, Inc.; 2018.
Two study groups were:TAU=buprenorphine + clinician visits + contingency managementTES=buprenorphine + clinician visits + contingency management + reSET-O
Ask your Sandoz Digital Therapeutics Specialist to show you a product demonstration
IMPROVE THE IMPACT OF YOUR OUD PATIENT THERAPY WITH reSET-O™11
CLINICALLY VALIDATED TO INCREASE RETENTIONof patients with OUD in outpatient treatment (TES, 82.4%; TAU, 68.4%; P=0.0224)11
For questions and technical support, contact your reSET ConnectTM Patient Service Center Call: 1-833-MY RESET (1-833-697-3738), Monday–Friday, 8 AM–6 PM ET
TRACK PATIENT-REPORTED BUPRENORPHINE CHECK-INSthat support patients’ current therapy regimens and facilitate transparency in patient-clinician dialogue11
IMPROVES THE IMPACT OF OUTPATIENT OUD THERAPYby providing 24/7 access to cognitive behavioral therapy, contingency management, and fl uency training11
TRACKS MEASURABLE RESULTSthat help you focus on patients’ progress to make face-to-face meetings more meaningful11
Visit www.reSETforRecovery.com
CLINICALLY VALIDATED TO INCREASE RETENTION of patients with OUD in outpatient treatment (TES, 82.4%; TAU, 68.4%; P=0.0224)11
MEETS MAT REQUIREMENTS FOR OUTPATIENT BEHAVIORAL THERAPY with evidence-based and consistent delivery of cognitive behavioral therapy, contingency management, and fluency training9,11
FOSTERS GREATER ENGAGEMENT AND ACCESS with interactive modules whose therapeutic content is available via patients’ smartphone or tablet11
THE 24/7 ACCESS TO reSET-O™ CAN CHANGE EVERYTHING11
GAIN DEEPER INSIGHTS INTO YOUR PATIENTS’ PROGRESS TOWARD RECOVERY WITH THE CLINICIAN DASHBOARD11
View patient summary, personal information, prescription status, clinician-entered drug screen results, and appointment attendance
Follow patient-reported buprenorphine check-ins, substance use, cravings and triggers, as well as lesson completion
See the severity and intensity of patient-reported cravings and triggers
Enter drug screen results, to further guide the conversation
HELP CLOSE TREATMENT GAPS WITH A PRESCRIPTION DIGITAL THERAPEUTIC LIKE reSET-O
FOLLOW
SEE
ENTER
VIEWImportant Safety Information:Warnings: reSET-O is intended for patients whose primary language is English and who have access to an Android/iOS tablet or smartphone. reSET-O is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).
Clinicians should not use reSET-O to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET-O to communicate to their clinician any urgent or emergent information. In case of an emergency, patients should dial 911 or go to the nearest emergency room.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). reSET-O does not replace care by a licensed medical practitioner. reSET-O does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider. The ability of reSET-O to prevent potential relapse after therapy discontinuation has not been studied.