Actively Recruiting
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
Led by Evon Medics LLC · Updated on 2024-05-30
300
Participants Needed
3
Research Sites
103 weeks
Total Duration
On this page
Sponsors
E
Evon Medics LLC
Lead Sponsor
H
Howard University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 80 years inclusive at enrollment
- Diagnosis of current moderate or severe substance use disorder involving opioids, stimulants (cocaine and methamphetamine), or alcohol in the past three months including the past month
- No current substance use disorders outside of those listed above, except mild or moderate cannabis use
- Willingness to receive study interventions and medications such as buprenorphine or naltrexone during the study
- Females must not be pregnant at enrollment and agree to use effective contraception during the trial
- Willingness to sign the informed consent form
- Stable housing to securely retain the EDITOR device throughout the study
You will not qualify if you...
- Significant neurological diseases such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures
- Mental retardation
- Serious mental illnesses including schizophrenia, bipolar disorder, or suicidal risk
- Current suicidal thoughts or plans
- Unstable medical conditions like uncontrolled hypertension, diabetes, or liver cirrhosis
- History of severe nose injury or significant intranasal disease affecting smell
- Allergies or intolerance to plant essential oil aromas such as orange or lemon
- Breastfeeding, pregnancy test positive, or plans to become pregnant within 6 months after enrollment
- Individuals on parole or probation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, United States, 20002
Actively Recruiting
2
Howard University
Washington D.C., District of Columbia, United States, 20060
Actively Recruiting
3
Maryland Treatment Center
Rockville, Maryland, United States, 20853
Enrolling by Invitation
Research Team
E
Evaristus Nwulia, MD
CONTACT
O
Opeyemi M Awofeso, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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