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Behavioural Intervention

Olfactory Training for Substance Use Disorders (EDITOR Trial)

Phase 2
Recruiting
Led By Evaristus Nwulia, MD
Research Sponsored by Evon Medics LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 - 80 years, inclusive at enrollment
Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
Must not have
Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to three months

Summary

This trial aims to test a new device called Enhanced Digital-Chemosensory-Based Olfactory Training for managing substance use disorders in clinics. They will compare this device to standard treatment and another device called

Who is the study for?
This trial is for adults with substance use disorders, including opioid, methamphetamine, cocaine, and alcohol addiction. Participants will be recruited from community clinics and must be currently receiving treatment.
What is being tested?
The study tests the EDITOR device—a digital-chemosensory olfactory training tool—against standard treatments and a control CBOT device. It aims to see if EDITOR can improve patient outcomes like staying in treatment longer and maintaining abstinence.
What are the potential side effects?
Since this trial involves behavioral therapy devices rather than medication, traditional side effects are not applicable. However, participants may experience discomfort or frustration with the technology or tasks involved.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 80 years old.
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I am not pregnant and agree to use birth control during the trial.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any major neurological conditions like stroke or epilepsy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to three months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to three months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Retention in SUD treatment
SUD Relapse Rate
SUD engagement
Secondary study objectives
Addiction Severity Index (ASI)
Cocaine Craving Questionnaire-Brief (CCQ-Brief)
Opioid Craving Scale (OCS)
+3 more

Side effects data

From 2016 Phase 3 trial • 230 Patients • NCT01109849
63%
loss of appetite
49%
irritability
48%
anxiety
42%
skin picking
41%
trouble sleeping
35%
depressed mood
32%
stomachache
29%
headache
26%
dull, listless
20%
socially withdrawn
18%
motor/verbal tics
15%
buccal movements
1%
abdominal pain
1%
appendicitis
1%
self injurious behavior
1%
shortness of breath
100%
80%
60%
40%
20%
0%
Study treatment Arm
Dose Optimzed
Behavior Therapy
ER Stimulant

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)Experimental Treatment1 Intervention
The EDITOR device is designed to stimulate intensive neural activity in OFC over long periods of time. It consists of 40 daily cycles of intervention with a combination of olfactory stimulation and training tasks, lasting \~45 minutes, delivered once daily over three months. The device also includes 60% beta-caryophyllene chemosensory stimulation to target AUD and stimulant use disorder and 10 digital enhancements for the purpose of remote treatment, remote acquisition of behavioral and physiological data, and seamless data transmission to providers, through a HIPAA-compliant clinic end portal. Participants assigned to this arm will receive their treatment-as-usual (TAU) alongside daily EDITOR therapy for three months. TAU will depend on the drug abused \[Buprenorphine with a median dose of 24 mg (range 16 - 32 mg) for Opioid use disorder and naltrexone (50-100 mg daily for Alcohol use disorder (AUD).
Group II: Chemosensory-Based Olfactory Training (CBOT)Active Control1 Intervention
CBOT with olfactory stimulants \& orbitofrontal (OFC) tasks TAU same as above + CBOT (Chemosensory-Based Olfactory Training) therapy (40 cycles of olfactory stimulation and OFC training tasks, lasting \~45 minutes, once daily over three months) + use of their smartphone to communicate with their clinic provider/staff
Group III: Chemosensory-Based Olfactory Training (CBOT) ShamPlacebo Group1 Intervention
Control Device (Sham) is CBOT device without olfactory stimulants and orbitofrontal tasks. TAU same as above + CBOT sham + use of their smartphone to communicate with their clinic provider/staff. This CBOT device uses compressed room air scented with phenylethylamine (rose scent) instead of olfactory stimulants and has shape pattern matching tasks instead of cognitive tasks in order to blind users to their treatment assignment. Similar to the active arm, sham COT will be used daily for 45 minutes.

Find a Location

Who is running the clinical trial?

Howard UniversityOTHER
42 Previous Clinical Trials
14,689 Total Patients Enrolled
Evon Medics LLCLead Sponsor
3 Previous Clinical Trials
476 Total Patients Enrolled
Maryland Treatment CenterUNKNOWN
~75 spots leftby Mar 2025
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