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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: Recruiting Phase 2 study of Opioid Use Disorder and Alcohol Use Disorder, sponsored by Evon Medics.
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. According to ClinicalTrials.gov, the official US trial registry.
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
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
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2023-07-07 |
| Est. Completion | 2025-06-30 |
| Phase | Phase 2 |
What NCT06434818 shows while recruiting
NCT06434818 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 4,655-participant average among 257 other Opioid Use Disorder trials with a reported enrollment target (94% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06434818's enrollment target sits among peer trials
300 57th of 257 higher than 196 of 257 other Opioid Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Opioid Use Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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