National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN)-0100 study funded by the National Institutes of Health (NIH) Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative, will use Pear’s prescription digital therapeutic (PDT) reSET-O®
- CTN-0100 will study reSET-O, in conjunction with high- and standard-dose transmucosal buprenorphine, extended-release injectable buprenorphine, and extended-release injectable naltrexone, to evaluate treatment optionality in a multi-site randomized trial.
BOSTON & SAN FRANCISCO–(BUSINESS WIRE)–Pear Therapeutics, Inc. today announced the first participant enrolled in the National Institute on Drug Abuse (NIDA) Clinical Trials Network (CTN)-0100 study on optimizing retention, duration, and discontinuation strategies for pharmacotherapy treatment of opioid use disorder (OUD), using Pear’s prescription digital therapeutic (PDT) reSET-O®. Investigators will study reSET-O, in conjunction with high- and standard-dose transmucosal buprenorphine, extended-release injectable buprenorphine, and extended-release injectable naltrexone in a multi-site randomized trial. The study is funded by the Helping to End Addiction Long-term Initiative, or NIH HEAL Initiative. NIDA is part of the National Institutes of Health.
The mission of this work is to develop data to inform and improve OUD treatment strategies for patients and providers. Pear’s participation in the study is part of its commitment and leadership in developing clinical evidence across patient populations and pharmacotherapies.
“The ultimate treatment goal of patients with OUD is sustained retention in treatment, reduction of substance use, and improved quality of life. Pear is committed to expanding the clinical evidence for our PDTs to better address unmet patient needs, and we thank the patients and investigators participating in the CTN-0100 study,” said Yuri Maricich, M.D., Chief Medical Officer at Pear Therapeutics. “Through the NIH HEAL Initiative, the National Institute on Drug Abuse, the largest supporter of the world’s research on drug use and addiction, established a clinical trial agreement with Pear for reSET-O to be part of CTN-0100, an important study dedicated to evaluating treatment optionality to improve outcomes for patients with OUD.”
Pear’s FDA-authorized PDTs support patient and clinical success by placing evidence-based therapy and treatment accountability in the palm of the patient’s hand. Through Pear’s reSET-O patients have access to algorithm-driven behavioral therapies that are designed to drive engagement and improve clinical outcomes1-2. Using the Pear platform, clinicians can track patient treatment compliance and progress. PDTs are designed to collect real world data for use by prescribing clinicians and for population health management by payors and health systems. Pear intends to increase access to PDTs by adding them to standard formularies.
Disclaimer: The study described in this press release is funded and supported by the Clinical Trials Network at the National Institute on Drug Abuse, part of the National Institutes of Health, (UG1DA013035; UG1DA015831), as part of the NIH HEAL Initiative. The content in this press release is solely the responsibility of the authors and does not represent the official views of the National Institutes of Health.
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, including the first three PDTs with disease treatment claims from FDA. Pear’s lead product, reSET®, for the treatment of substance use disorder, was the first PDT to receive marketing authorization from 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.
reSET-O Important Safety Information
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.
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.
- 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.
- Yuri A. Maricich, Warren K. Bickel, Lisa A. Marsch, Kirstin Gatchalian, Jeffrey Botbyl & Hilary F. Luderer (2020) Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder, Current Medical Research and Opinion, DOI: 10.1080/03007995.2020.1846022.
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