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RECRUITING
NCT06434818
PHASE2

Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders

Sponsor: Evon Medics LLC

View on ClinicalTrials.gov

Summary

The overarching goal of this study phase, Phase II component is to implement Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in substance use disorder (SUD) clinics to demonstrate pilot effectiveness for SUD outcomes compared to treatment as usual (TAU) and Computerized Chemosensory-Based Orbitofrontal Networks Training (CBOT) device as active control. The investigators will conduct a multi-site study of 300 adult patients with opiate use disorder (OUD), stimulant (i.e., cocaine, methamphetamine) and/or alcohol use disorder (AUD) from community and clinics to evaluate whether EDITOR is associated with better patient treatment outcomes (e.g., retention in treatment and abstinence). The pilot study will provide preliminary data needed for design of a Phase III trial, including estimates of effect size. The investigators will also explore development of machine learning/AI algorithms integrating clinical and physiological data into treatment decision guides for providers.

Official title: Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2023-07-07

Completion Date

2025-06-30

Last Updated

2024-05-30

Healthy Volunteers

No

Interventions

COMBINATION_PRODUCT

EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)

EDITOR includes a user-friendly cloud portal synced with the main device, providing a comprehensive training program for the orbitofrontal cortex (OFC). The main device stimulates the orbitofrontal cortex intensely, preventing habituation to smells and improving adaptability. This enhances neurobehavioral plasticity, benefiting Substance Use Disorder (SUD) outcomes. The device also features a 60% beta-caryophyllene scent for addressing issues like Alcohol Use Disorder and stimulant use disorders. With ten digital enhancements, it enables remote treatment and data collection, seamlessly transmitting information to healthcare providers through a secure, HIPAA-compliant portal.

COMBINATION_PRODUCT

CBOT with olfactory stimulants & OFC tasks

The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.

COMBINATION_PRODUCT

CBOT Sham

CBOT Sham uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks

Locations (3)

Clinics of Dr. Edwin Chapman @ MHDG

Washington D.C., District of Columbia, United States

Howard University

Washington D.C., District of Columbia, United States

Maryland Treatment Center

Rockville, Maryland, United States