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RECRUITING Phase 2

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

NCT06434818 · View on ClinicalTrials.gov ↗

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.

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

31 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. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Evon Medics, which has 31 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06434818 reports 3 study locations spanning 2 distinct geographic areas — top geographies include District of Columbia, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06434818?

This trial is sponsored by Evon Medics, which has 31 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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