reSET and reSET-O are the first ever FDA-authorized prescription digital therapeutics (PDTs) for Substance use disorder (SUD) and Opioid use disorder (OUD)
ReSET and reSET O are the first, and only, FDA-authorized Prescription Digital Treatments (PDTs).
PDTs, are software-based (digital) disease treatments, such as a smartphone or computer app. PDTs are designed to directly treat disease, tested for safety and efficacy in randomized clinical trials, evaluated by the FDA, and prescribed by healthcare providers.
PDTs are designed and tested much like traditional prescription drugs with one distinction: rather than swallowing a pill or taking an injection, patients are treated with software. patients with substance use disorder (SUD) and opioid use disorder (OUD) with 24/7 access to evidence-based behavioral techniques, such as cognitive-behavioral therapy and fluency training. 2,3
reSET® and reSET-O® are for patients 18 and older in outpatient treatment under the supervision of a clinician.
These PDTs are adjunctive therapies that have been proven in clinical studies to be effective in helping patients with SUD and OUD. 1,4
(Providers, please see the Clinician Brief Summary Instructions for reSET and reSET-O.)
reSET: The first-ever FDA-authorized prescription digital therapeutic for SUD:
· Adding reSET to outpatient therapy significantly improved abstinence and retention in the treatment of patients with SUD in a 12-week study. 2
· The Clinician Dashboard (to be used by the prescribing professional), provides an analysis of patients’ progress, giving the clinician more insight into their patients’ behaviors between in-person visits.2
· Interactive treatment modules deliver cognitive behavioral therapy and fluency training to reinforce proficiency.2
· reSET is for English speaking patients only. reSET is not intended as a stand-alone treatment and does not replace care by a licensed medical practitioner.
reSET-O: The first ever FDA-authorized prescription digital therapeutic for OUD
· Adding reSET-O to outpatient treatment using buprenorphine increased retention in the treatment of patients with OUD in a 12-week study. 3
· The Clinician Dashboard shows patient-reported buprenorphine adherence, giving the clinician more insight into their patients’ behaviors between in-person visits.3
· Interactive treatment modules deliver cognitive behavioral therapy and fluency training to reinforce proficiency.3
· reSET-O is for English speaking patients only. reSET-O is not intended to be used as a stand-alone therapy for OUD and does not replace care by a licensed medical practitioner. Do not report emergency information via reSET-O.
Link to site!: RESETFORRECOVERY.COM
References: 1. Campbell ANC, Nunes E V, Matthews AG, et al. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014;171(6):683-690.doi:10.1176/appi.ajp.2014.13081055 2. reSET Clinician directions for use (LBL001.G – 2019-06-20). Pear Therapeutics, Inc; 2019. 3. reSET-O Clinician directions for use (LBL017.B – 2019-06-20). Pear Therapeutics, Inc.; 2019. 4. 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.
** Information provided by Pear Therapeutics, developer of these new, innovative medical products.