From therapists and psychiatrists to patients and caregivers, everyone involved in treatment plays a critical role. These are their stories.
“As a national leader in opioid treatment, we are committed to bringing best-in-class treatment options to those struggling with opioid use disorder. reSET-O is a complementary therapy to our outpatient treatment program that has already shown to be successful in keeping more patients in treatment. Our collaboration with Pear means more people will get access to the support they need to fight opioid addiction.”
—Rupert McCormac, MD, CEO of Crossroads Treatment Centers
“With reSET-O, we have an opportunity to uniformly offer an evidence-based treatment. As a physician, to be able to say, ‘Look, I do have something that I can give you, that we can incorporate into your overall treatment that may be a benefit’ makes me feel like I'm doing something for the patient.”
— Michael Frost, MD, FACP, FASAM Addiction Medicine
For individuals with opioid use disorder, reSET-O is the only FDA-authorized Prescription Digital Therapeutic (PDT) clinically proven to help patients stay in treatment longer. It works with buprenorphine medication assisted therapy to reinforce new ways of thinking and can increase the chances for success with recovery.1,2
For individuals with substance use disorder, reSET is the first FDA-authorized Prescription Digital Therapeutic (PDT) clinically proven to help patients improve abstinence and stay in treatment longer. It works in conjunction with in-person or remote therapy to reinforce new ways of thinking to support recovery.3,4
“It can happen to anybody. Never in my wildest dreams did I believe I’d be sitting here saying, I did heroin. I started doing drugs at 53 years old.”
—Heidi, reSET-O patient
“I was taking opiates for chronic pain problems. I started taking more of them after my brother died. I felt that they made me feel normal, but I realized there’s a better way."
—Colleen, reSET-O patient
“I’ve got four kids. I couldn’t get out of bed unless I popped a pill in the morning. reSET-O helped me. I’ve been clean for two years now.”
—Tara, reSET-O patient
From remote prescribing options and technical assistance for clinicians to dedicated patient support throughout treatment, PearConnect™ specialists are here to help.
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 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.
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.
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:
Important Safety Information for Clinicians:
Warnings: reSET is intended for patients whose primary language is English 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. reSET does not represent a substitution for a patient’s medication. Patients should continue to take their medications as directed by their healthcare 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.
Please see the Clinician Brief Summary Instructions for reSET.
References:
1. 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
2. reSET-O 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. reSET Clinician directions for use. Pear Therapeutics, Inc. 2020.
