BOSTON–(BUSINESS WIRE)–Pear Therapeutics, Inc. presented results today from an open-label study that evaluated participant engagement and satisfaction with reSET® and reSET-O®, prescription digital therapeutics (PDTs) that deliver evidence-based disease treatment through cognitive behavioral therapy, fluency training and contingency management for substance use disorder (SUD) and opioid use disorder (OUD) via mobile device.
Study participants showed high rates of engagement with reSET and reSET-O and reported high satisfaction. Study results were presented as part of the American Society of Addiction Medicine (ASAM) Virtual 2020 program, which provides high-quality education, innovative topics, sessions and posters in a completely online platform. The 51st Annual ASAM Conference live event was cancelled due to recent COVID-19 developments.
“Research shows that patient engagement and satisfaction with substance use treatment correlates with positive outcomes, including retention in treatment,” said Michael Hassman, D.O., principal study investigator and Chief Scientific Officer at Hassman Research Institute. “This study provides additional evidence that PDTs can play a vital role in treatment models for SUD and OUD, diseases with significant unmet needs and multiple barriers to care.”
● Nearly all participants were motivated/very motivated to use their PDT at baseline. Continued engagement was observed throughout the 12-week study, with the majority of participants (59% reSET; 71% reSET-O) still using their PDT at week 12.
● Participants reported the therapeutic content was easy to understand (90%), relevant (80%), and helpful (100%).
● Most (>85%) participants reported practicing skills learned from therapy lessons daily or weekly.
● Some (14% reSET; 8% reSET-O) participants found it challenging to incorporate reSET and reSET-O into daily life.
● The high concordance between self-reported substance use/non-use and urine drug screen data, 83.3% for participants assigned reSET-O and 86.3% for participants reSET, was consistent with reported literature describing the reliability of the Timeline Follow Back self-report method.
For more detailed information, please see poster 025-Open-label Study Evaluating Engagement with Prescription Digital Therapeutics for SUD in the ASAM Virtual 2020 Poster Gallery.
About the Study
This open-label study (Hassman Research Institute) enrolled 34 outpatient participants with SUD (n=17) and OUD (n=17). Participants received reSET (90 days) or reSET-O (84 days) with biweekly therapist appointments and urine drug screens (UDS). Participants were asked to complete 4 PDT therapy lessons each week and were prompted to self-report substance use/non-use every four days by their assigned PDT. All participants with OUD received buprenorphine. Surveys and/or structured qualitative interviews were performed at baseline, week 4 and week 12 to evaluate satisfaction with reSET or reSET-O. Interview responses were analyzed for common themes and engagement (e.g. PDT usage) was quantified from user activity logs. Median number of participant self-reports was quantified to evaluate feature engagement and the concordance between UDS and self-report data was evaluated.
reSET Important Safety Information
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.
Important Safety Information:
Warnings: reSET is intended for patients whose primary language is English and whose reading level is at the 7th grade level 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 represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare provider.
reSET should not be used by individuals outside active enrollment in a SUD treatment program. It should only be used as an adjunct to face-to-face counseling and contingency management. reSET is not intended to reduce the amount of face-to-face clinician time.
The long-term benefit of treatment with reSET on abstinence has not been evaluated in studies lasting beyond 12-weeks 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.
This Press Release does not include all the information needed to use reSET safely and effectively. Please see the full Clinician Brief Summary for reSET for more information.
reSET-O Important Safety Information
reSET-O® 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 prescription 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).
reSET-O should not be used by individuals outside active OUD treatment. It is not intended to replace treatment by you, the patient’s medical provider. It should be used as an adjunct to clinician treatment, buprenorphine treatment and contingency management.
reSET-O is not intended to be used as a stand-alone therapy for Opioid Use Disorder (OUD). 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.
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.
This Press Release does not include all the information needed to use reSET-O safely and effectively. Please see the full Clinician Brief Summary Instructions for reSET-O for more information.
About Pear Therapeutics
Pear Therapeutics is the leader in prescription digital therapeutics, or PDTs. Pear aims to redefine medicine by discovering, developing, and delivering clinically validated software-based therapeutics to provide better outcomes for patients, smarter engagement and tracking tools for clinicians, and cost-effective solutions for payers. Pear has a pipeline of products and product candidates across therapeutic areas. Pear’s lead product, reSET®, for the treatment of Substance Use Disorder, was the first PDT to receive marketing authorization from the FDA to treat disease. Pear’s second product, reSET-O®, for the treatment of Opioid Use Disorder, was the first PDT to receive Breakthrough Designation. Pear’s third product, Somryst™ for the treatment of chronic insomnia, was the first PDT submitted through FDA’s traditional 510(k) pathway while simultaneously reviewed through FDA’s Software Precertification Pilot Program. For more information, visit Pear at www.peartherapeutics.com.
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