Applications under this FOA are encouraged, but not required, to apply approaches and tools developed under the NIH Common Fund’s Science of Behavior Change (SOBC) Program. These include: use-inspired research on mechanisms of change at multiple levels of analysis; assays for self-regulation, interpersonal processes and stress that have evidence as malleable targets for behavior change (see https://osf.io/zp7b4) developed under the SOBC program; and an experimental medicine approach which requires a clear a priori specification of the intended mechanistic target(s) of an intervention, and methods that test the degree to which an experimental manipulation or intervention engages those targets. For more information about the SOBC program, please see: https://commonfund.nih.gov/behaviorchange.
In the past year, more than 20.2 million Americans are reported to have a substance use disorder (SUD). For example, there are reported 115 overdoses per hour; annually, this includes 20,000 overdose deaths related to pain relievers and 13,000 related to heroin. These devastating death rate statistics have tripled since 2000. Although there are safe and effective FDA-approved pharmacotherapies for SUDs (i.e., buprenorphine, and methadone), relapse prevention (i.e., depot naltrexone), withdrawal (i.e., Lofexidine), and opioid overdose (i.e., naloxone), they are underutilized and adherence is suboptimal. Additionally, pharmacotherapies are used as standalone treatments, there is significant clinical evidence that pharmacotherapy can be more effective when combined with behavioral therapy. Indeed, the labeling for these pharmacotherapies include a recommendation that patients also receive behavioral intervention. New modalities should be considered to bring forward novel treatments that improve adherence to address this crisis. Digital therapeutics (e.g., mobile medical app/device platforms and other digital technologies) to support medication adherence and improve disease management for a variety of chronic diseases is a growing area. However, further support is urgently needed to help focus research and development efforts on adherence to FDA approved SUD treatment to improve outcomes and prevent relapse.
One possible solution to increase adherence is through reward-based interventions (e.g., contingency management) in which patients are provided tangible rewards to reinforce positive behaviors. These treatments are highly effective and have been evaluated across a variety of settings. Despite positive outcomes on treatment retention and drug abstinence, reward-based treatments are not widely disseminated. Reasons for the lack of use include cost, lack of sustainability once rewards or contingencies are removed, and lack of clear regulatory and reimbursement strategies. Some of these concerns may be addressable through new opportunities in digital technologies. The 21st Century Cures Act clarified the FDA regulation of medical software and there are now several examples of breakthrough digital technologies that obtained key FDA approval. One example is an FDA cleared mobile medical application to help treat SUDs. The device delivers cognitive behavioral therapy skills to patients that aid in SUD treatment to increase drug abstinence and increase retention in outpatient therapy programs. Another example is a combination product, a pill that includes a digital ingestion tracking system that records whether the prescribed medication has been ingested. The approval of these technologies, coupled with the high cost of relapse, create an opportunity for the development and commercialization of loyalty/reward-based devices as digital therapeutics to increase medication adherence. Such novel strategies have the ability to develop an ecosystem to deliver rewards, monitor patient progress as well as improve adherence in a self-sustaining manner.
The purpose of this Funding Opportunity Announcement is to develop and evaluate the loyalty/reward-based digital technologies (e.g., mobile medical app/device platforms and other digital technologies) to be used as a combination product to increase SUD medication adherence. The objective of Phase I (R43) is to establish the feasibility and/or validation of the device, and Phase 2 is designed to test the efficacy of the reward-based platform in a larger sample. The primary endpoint is adherence to FDA-approved medications for any SUD. Rewards and contingencies should be delivered in a self-sustaining manner and include a front-end interface allowing treatment providers to monitor progress and deliver rewards. Platforms may include novel features including, but not limited to, automated tracking tools, real-time assessments of patient progress, medication intake, and momentary assessment. Data generated from these studies are to be used to support a 510k submission to seek clearance as an FDA cleared device.
Phase I Activities (R43):
Develop platform to increase sustainability of loyalty/reward programs to facilitate adherence to SUD pharmacotherapy; conduct small pilot study to test program with patients and treatment providers to establish feasibility.
Required Product Features
Project should specify whether the platform will be used in one of three recovery periods: 1) Pre-detoxification, 2) Post-detoxification or 3) Maintenance
Phase 2 Activities (R44):
Test efficacy of loyalty/reward platform as a combination product with any single FDA-approved medication to treat SUD with the primary endpoint of adherence.
The intent of this FOA is to take FDA-approved treatments for substance use disorders and develop programs to increase adherence to approved treatments. Applications that are focused on developing adherence programs for non-FDA-approved treatments are considered non-responsive and will be withdrawn prior to peer review.
See Section VIII. Other Information for award authorities and regulations.
- Mobile digital therapeutic app, device platforms, and/or modules that integrate tenets of reward-based interventions
- Front End (Patient): Voucher like system, loyalty points reward based upon achieving positive behaviors (e.g. drug-negative urinalysis, medication adherence)
- Front End (Physician/Counselor): Features ability for physician/treatment provider to monitor patients’ progress and interact
- Go/no-go decision tree with quantitative, not subjective milestones
- Objective measures that examine both the delivered dosage/treatment duration and confirmation of adherence platform
- Studies designed to address all project-specific questions of feasibility.
- Development plan with the appropriate regulatory authorities at the FDA and provide a regulatory pathway application.
- Complete a 4-week, proof-of-concept clinical study to assess the feasibility and acceptability of the reward/loyalty platform. The study should have a minimum of 10 enrolled participants and a minimum of 1 treatment provider.
- A milestone on the acceptability of integrating reward-based platform with pharmacotherapies or behavioral therapies to maximize treatment efficacy, functional and/or clinical outcomes will be required
- Complete a clinical study to assess the efficacy (consistent with FDA guidelines for efficacy) of the reward/loyalty platform. The study should have a minimum of 20 enrolled participants and a minimum of 4 treatment providers.
- Project should specify whether the platform will be used in one of three recovery periods: 1) Pre-detoxification, 2) Post-detoxification or 3) Maintenance
- Detailed commercialization plan, including cost analysis, market strategy, sales and reimbursement possibilities
- Pursue FDA Authorization to Treat SUD as a combination product.