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NCT06434818 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Opioid Use Disorder and Alcohol Use Disorder, sponsored by Evon Medics.

Recruiting
Registry status
Phase 2
Development phase
300
Enrollment target
3
Study locations

NCT06434818 is a Phase 2 study of Opioid Use Disorder and Alcohol Use Disorder that is actively recruiting participants, run by Evon Medics. The registered enrollment target is 300 participants, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower). The trial reports 3 study locations across 2 states.

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The verdict

NCT06434818, a Phase 2 study of Opioid Use Disorder and Alcohol Use Disorder, is actively recruiting participants, sponsored by Evon Medics.

RECRUITING
Registry status
Phase 2
Development phase
300 participants
Enrollment target
3
Study locations

Study 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 Studied

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

Interventions

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

Study Locations (3)

District of Columbia

  • Clinics of Dr. Edwin Chapman @ MHDG - Washington D.C.
  • Howard University - Washington D.C.

Maryland

  • Maryland Treatment Center - Rockville

Trial Details

FieldValue
Enrollment Target 300 participants
Start Date 2023-07-07
Est. Completion 2025-06-30
Phase Phase 2

Sponsor

Evon Medics

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06434818

The ClinicalTrials.gov registry entry for NCT06434818 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower). The listed sponsor is Evon Medics, which has 3 total studies on file at ClinicalTrials.gov.

The record links to 5 conditions, with Opioid Use Disorder appearing as the primary indexed condition, and to 3 interventions - of which EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) is the first listed.

NCT06434818 reports 3 study locations spanning 2 distinct geographic areas - top geographies include District of Columbia, Maryland.

Frequently Asked Questions

What is clinical trial NCT06434818 about?

NCT06434818 is a clinical study titled "Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders". 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...

What is the current status of trial NCT06434818?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 300 participants. The study started on 2023-07-07. Estimated completion is 2025-06-30.

What conditions does trial NCT06434818 study?

This clinical trial studies the following conditions: Opioid Use Disorder, Alcohol Use Disorder, Substance Use Disorders, Cocaine Use Disorder, Methamphetamine-dependence.

What interventions are being tested in trial NCT06434818?

The interventions under investigation include: EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance) (COMBINATION_PRODUCT), CBOT with olfactory stimulants & OFC tasks (COMBINATION_PRODUCT), CBOT Sham (COMBINATION_PRODUCT).

Who is sponsoring clinical trial NCT06434818?

This trial is sponsored by Evon Medics, which has 3 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06434818 being conducted?

This trial has 3 study locations across District of Columbia, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.