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

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.

Conditions

• Substance Use Disorders
• Opioid Use Disorder
• Alcohol Use Disorder
• Cocaine Use Disorder
• Methamphetamine-dependence

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

Sponsors & Collaborators

• Howard University

  collaborator OTHER

• Maryland Treatment Center

  collaborator UNKNOWN

• Clinics of Dr. Edwin Chapman, MD, PC @ MHDG

  collaborator UNKNOWN

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Evon Medics LLC

  lead INDUSTRY

Principal Investigators

• Charles Nwaokobia · Evon Medics LLC

• Evaristus Nwulia, MD · Evon Medics LLC

• Tanya Alim, MD · Howard University

• Edwin Chapman, MD · Clinics of Dr. Edwin Chapman at MHDG

• Marc Fishman, MD · Maryland Treatment Center

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-07-07

Primary Completion

2025-03-31

Completion

2025-06-30

FDA Drug

Yes

Countries

• United States

Study Locations