Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder

Summary

Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly brain stimulation system that increased 6-month treatment retention of OUDs in a pilot study; and also, acutely reduced opioid withdrawal severity and negative affect during induction into opioid maintenance therapy. This study will establish its effectiveness in a broad category of OUD subjects at different stages of OUD care continuum.

Conditions

• Opioid Use Disorder, Moderate
• Opioid Use Disorder, Severe
• Withdrawal Symptoms
• Craving
• Negative Affectivity

Interventions

DRUG

CBOT + TAU

The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time. It is paired with OFC-dependent cognitive tasks.

DRUG

Sham + TAU

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Howard University

  collaborator OTHER

• Family and Medical Counseling Service, Inc

  collaborator UNKNOWN

• Maryland Treatment Centers @ ARTC

  collaborator UNKNOWN

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

  collaborator UNKNOWN

• Evon Medics LLC

  lead INDUSTRY

Principal Investigators

• Evaristus A Nwulia, MD · Evon Medics LLC

• Tanya Alim, MD · Howard University

• Mark Johnson, MD · Howard University

• Marc Fishman, MD · Maryland Treatment Centers

• Michael Serlin, MD · Family and Medical Counseling Service, Inc

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

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-03-26

Primary Completion

2022-11-30

Completion

2022-12-31

FDA Drug

Yes

Countries

• United States

Study Locations