NCT04850664

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

Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Evon Medics LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Evon Medics proposes to evaluate the effectiveness of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT), as an alternative strategy for relapse prevention in patients with Opioid Use (OUD) and other substance use disorders (SUD). This treatment leverages the overlap in brain regions that process smell and mediate decision making. The CBOT is portable and can be used at home. This clinical trial is being conducted to demonstrate its utility for home application by nontreatment seeking and treatment-seeking OUD populations, to engage in long-term, successful opioid recovery. Key objectives of this project are to: (1) establish the effectiveness of CBOT for improved retention and relapse prevention in a large sample of OUD subjects; (2) establish its effectiveness for acute reduction of withdrawal severity and negative affect early in recovery; and (3) evaluate its safety, user-friendliness and acceptability. Accomplishment of these goals would lead to larger clinical trials for OUD and wider applications of CBOT in other addictive disorders.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-26
• Primary completion: 2022-11-30
• Completion: 2022-12-31
• First posted: 2021-04-20
• Last updated: 2021-08-06

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated drug study