ABSTRACT The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) a patient-facing culturally-adapted digital- chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially-disadvantaged and sexual minority populations. Management of substance use disorders (SUD) mostly involve direct contact between patients and providers, but the precedence of COVID-19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, our communities of African Americans (AA), Hispanic-Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for Opioid Use Disorders (OUD), there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal. Through Phase I SBIR, EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for our socially disadvantaged AA, HA and MSM population, we recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta-caryophyllene chemosensory stimulation. We propose further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, Stimulant (cocaine and methamphetamine) use and alcohol use disorders through Fast-Track SBIR funding. In Phase I, we will configure the patient-facing platform with: voice commands with different languages especially for the non-English speaking, non-Wi-Fi or internet-dependent connectivity solution and reliable pupillary, pulse rate, other physiological and psychological (e.g., craving) acquisitions; and the provider-facing component to provide interpretation of patients’ data in a HIPAA-secure portal. We will do preliminary testing in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland. In Phase II, we will perform a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University. Upon completion of Phases I and II, we will be poised to expand the research to either a larger, Phase III efficacy study, or an implementation study of effectiveness in the real-world setting through commercial partnerships developed over the course of this project. To the best of our knowledge, this will be the first evaluation of Digital-Chemosensory-Based platform for remote management of SUD, culturally adapted for socially disadvantaged communities and populations.

NARRATIVE The proposed study will develop a sustainable, scalable, and patient-centered mobile health combinatorial product, Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR), comprised of (1) a patient-facing culturally-adapted digital-chemosensory platform for treatment of substance use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting these sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially-disadvantaged minority populations. The proposal will optimize a Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) platform for socially disadvantaged minority populations and will evaluate the effectiveness for remote treatment of opioid use disorder, cocaine use disorder and alcohol use disorder in medically underserved populations. Accomplishment of the Aims will lead to a commercially ready product that seamlessly links patients and providers, provides effective novel treatment for stimulant use disorder, and improves remote management of SUD in digitally challenged populations.