Proven Outcomes

Clinical evidence

Clinical studies have proven reSET® and reSET-O® to be effective in helping improve outcomes in patients with substance use disorder (SUD) and opioid use disorder (OUD).1,2

reSET-logo-dark-gray

reSET® is used to treat SUD as an adjunct to outpatient therapy.

In a 12-week study of reSET1:

In patients whose primary substance of abuse was not opioids, adding reSET to outpatient treatment as usual (TAU) more than doubled abstinence rates during the last 4 weeks of the 12-week trial:
  • 17.6% with TAU (n=193) vs 40.3% with rTAU* + reSET (n=206); P=.0004
reSET-O-logo-dark-gray

reSET-O® is used to treat OUD as an adjunct to outpatient therapy that includes transmucosal buprenorphine.

In a 12-week study of reSET-O2:

Case studies

See how reSET and reSET-O helped real practices by downloading our case studies.

The Perfect Tools at the Perfect Time

Coastal Spine and Pain Center, headquartered in Jacksonville, Florida, serves patients with acute and chronic pain—many of whom have acquired OUD.

reSET-O®: The Inner Champion

To combat the opioid epidemic, in early 2019, Ashland Integrative Medicine’s physicians began prescribing reSET-O to help its patients with OUD, most of whom are on Medicaid.

reSET-O®: Steady Support for Those on a Recovery Journey

Fritz Clinic has been helping people battling OUD since 2010. With hundreds of patients treated each week by clinicians in 6 locations across Alabama, innovative tools to enhance patient engagement, treatment, and retention are top of mind for the clinic.

reSET-O®: A Win/Win for Clinics and Clients

At 3 CRN locations across Ohio, case managers begin their reSET and reSET-O pitches to patients the moment they walk through the door, and their enthusiasm for the platforms has resulted in 312 prescriptions (64% have been filled) as of May 2021.

reSET-O®: A 24/7 Support for Patients

With more than 300 prescriptions written and a fulfillment rate of 43%, reSET-O has become a critical component of the outpatient therapy offerings at DeNova Behavioral Health Services in Lexington, Kentucky.

Supporting Women-Centered Recovery Journeys with reSET

At Anew Chemical Health Services in St. Paul, MN, the enthusiasm for reSET and reSET-O has been growing, with the clinic currently seeing more than half of all prescriptions getting renewed after the first 12 weeks
Interested in prescribing reSET or reSET-O?

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 Clinicians:

Warnings: reSET is intended for patients whose primary language is English with a reading level of 7th grade or above, and who have access to an Android/iOS tablet or smartphone. reSET is intended only for patients who own a smartphone and are familiar with use of smartphone apps (applications).

Clinicians should not use reSET to communicate with their patients about emergency medical issues. Patients should be clearly instructed not to use reSET 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 is not intended to be used as a stand-alone therapy for substance use disorder (SUD). reSET does not replace care by a licensed medical practitioner and is not intended to reduce the amount of face-to-face clinician time. reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.

Patients with substance use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with substance use disorder also have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should engage in their normal care practices to monitor patients for medical problems and mental health disorders, including risk for harming others and/or themselves.

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 effectiveness of reSET has not been demonstrated in patients currently reporting opioids as their primary substance of abuse.

Please see the Clinician 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 Clinicians:

Warnings: reSET-O is intended for patients whose primary language is English with a reading level of 7th grade or above, 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 and is not intended to reduce the frequency or duration of in-person therapy. 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.

Patients with opioid use disorder experience mental health disease and co-morbid medical problems at higher rates than the general population. Patients with opioid use disorder have higher baseline rates of suicidal ideation, and suicide attempts, and suicide completion. Clinicians should undertake standard of care to monitor patients for medical problems and mental health disease, including risk for harming others and/or themselves.

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 Clinician Brief Summary Instructions for reSET-O.

References:

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

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

3. 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

4. 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

This information is intended for US healthcare professionals. Please confirm you are a healthcare professional to continue.