reSET®

Product Overview

Medical condition:

Substance Use Disorder (SUD)

Target patient population:

Patients with SUD, under treatment for addiction to: stimulants, alcohol plus another substance, marijuana, cocaine, opioids (when not the primary substance of abuse), and other substances.

What to expect:

Significant improvements in substance abstinence and treatment retention when used with outpatient therapy.

Note: for more information, please visit https://peartherapeutics.com/products/reset-reset-o/.

Clinical Overview

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, enrolled in outpatient treatment under the supervision of a clinician.

Outcomes:

Pivotal study demonstrated significant improvements in abstinence and treatment retention. Among patients whose primary addiction was not opioids, adding reSET® to outpatient therapy more than doubled abstinence rates (40% vs. 18%). Among all patients, adding reSET® to outpatient therapy improved rates of retention (76% vs. 63%). Patients who adhered to reSET® module completion in the first six weeks of the trial were 7x more likely to complete treatment than those who did not.

Directions:

reSET delivers therapy based on the community reinforcement approach (CRA), an intensive form of validated neurobehavioral therapy for SUD, along with contingency management and fluency training to enhance learning. Prescription duration is 12 weeks.

reSET is comprised of 62 interactive modules: 32 core modules and 30 supplemental modules. Core modules focus on key CRA concepts, building skills to support behavior change and prevent relapse. Supplemental modules provide more in-depth information on specific topics such as relationship skills or living with Hepatitis C. Each module can be completed in approximately 10-20 minutes.

Risks & warnings:

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. reSET® is not to be used for emergencies. In case of an emergency, patients should dial 911 or go to the nearest emergency room.

Place in therapy:
Complementary to current therapy. Outpatient treatment.

Product Access

Product description:

reSET is a prescription digital therapeutic created to deliver behavioral therapy modeled on the Community Reinforcement Approach (CRA), which is a specific form of Cognitive Behavioral Therapy (CBT) designed for patients with SUD.

reSET combines CRA (for therapy) and fluency training (to reinforce concept mastery) in conjunction with Contingency Management to support and incentivize patients with SUD in achieving abstinence and retention in outpatient SUD treatment.

Prescription status:

Yes, a prescription is required.

Patient access:

Patients download the reSET app through the Apple App Store or Google Play Store on their smartphone or tablet. An access code is given to them at the time of prescription.

The reSET app is supported on the following mobile operating systems:

• iOS
• Android

Patients should have access to a smartphone or tablet. Patients should be able to upload data periodically, i.e. have internet/wireless connection access.

Provider access:

Healthcare providers may review the patient’s use of reSET as well as their self-reported substance use, triggers and cravings via the reSET Clinician Dashboard.

The reSET Clinician dashboard is optimized for desktop computer access and is supported on the following web browsers:

• Google Chrome
• Firefox
• Microsoft Internet Explorer
• Microsoft Edge
• Safari

Coverage options:

reSET is typically paid for by fully insured health plans and self-insured employers as either a pharmacy benefit or a medical benefit. Co-payments, co-insurance, and deductibles may apply.

Product availability:

reSET is available in:

USA: FDA-cleared Class II Medical Device, 21 CFR 882.5801 Computerized behavioral therapy device for psychiatric disorders

Clinical Trials

The provided set of evidence represents a sample of conducted studies. For a comprehensive collection contact manufacturers directly.

• Study Title: Design and Methodological Considerations of an Effectiveness Trial of a Computer-assisted Intervention: An Example from the NIDA Clinical Trials Network
  Study Design: Study design / methodology paper
  Outcomes: Randomized controlled design (with independent treatment arm allocation), intention-to-treat primary outcome analysis, biological markers for the primary outcome of abstinence, long-term follow-up assessments, precise measurement of intervention dose, and a cost-effectiveness analysis.
• Study Title: Internet-delivered Treatment for Substance Abuse: A Multisite Randomized Controlled Trial
  Study Design: 507 participants w/ Substance Use Disorders related to Opioids, Cannabis, Alcohol, Stimulants, and/or Cocaine were enrolled and randomized to receive either Treatment as Usual (TAU) – standard treatment offered and prescribed, as usual, in the outpatient substance abuse treatment program consisting of 4 or more per week of face-to-face treatment, or TES (the academic version of reSET®) substituted for ~2hrs per week of standard face to face treatment at each site.
  Outcomes: Compared to treatment-as-usual, those receiving Therapeutic Education System (TES) reduced dropout from treatment (Hazard Ratio=0.72 [95% CI, 0.57-0.92], P=.010), and increased abstinence (Odds Ratio=1.62 [95% CI: 1.12-2.35], P=.010), an effect that was more pronounced among patients with a positive urine drug and/or breath alcohol screen at the point of study entry (n=228) (Odds Ratio=2.18 [95% CI: 1.30-3.68], P=.003).