Recruiting
Phase 2

Olfactory Training

Sponsor:

Evon Medics LLC

Code:

NCT06434818

Conditions

Substance Use Disorders

Opioid Use Disorder

Alcohol Use Disorder

Cocaine Use Disorder

Methamphetamine-dependence

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

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

CBOT with olfactory stimulants & OFC tasks

CBOT Sham

Study Details

Brief 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

Substance Use Disorders

Opioid Use Disorder

Alcohol Use Disorder

Cocaine Use Disorder

Methamphetamine-dependence

Study ID

NCT06434818

Start date

Jul 7, 2023

Status verified date

May, 2024

Completion date

Jun 30, 2025

Anticipated

Primary completion date

Mar 31, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age 18 - 80 years, inclusive at enrollment.
2. Diagnosis of current moderate or severe substance use disorders, opioid use disorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders in the past three months, including the past month.
3. Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
4. Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
5. Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
6. Willing to sign the informed consent form.
7. Have a stable place to stay and retain the EDITOR devices in a secure condition when receiving the intervention and during the entire duration of the study participation.

Exclusion Criteria:

1. Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
2. Mental retardation.
3. Presence of serious mental illness, such as schizophrenia, bipolar disorders, and suicidal risk. Diagnosis of major depressive disorders, anxiety disorders, and post-traumatic stress disorders (PTSD), will be included if symptoms are stable, with no suicidal ideas or plans, and there are no recent changes in treatment of these conditions in the 6 weeks prior to enrollment.
4. Experiencing current suicide ideas or plans.
5. Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
6. History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI.
7. Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon.
8. Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment.
9. Individuals who are on parole or probation.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)

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).

active comparator: Chemosensory-Based Olfactory Training (CBOT)

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

sham comparator: Chemosensory-Based Olfactory Training (CBOT) Sham

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.

Interventions

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

EDITOR includes a user-friendly cloud portal synced with the main device, providing a comprehensive training program for the orbitofrontal cortex (OFC). The main device stimulates the orbitofrontal cortex intensely, preventing habituation to smells and improving adaptability. This enhances neurobehavioral plasticity, benefiting Substance Use Disorder (SUD) outcomes. The device also features a 60% beta-caryophyllene scent for addressing issues like Alcohol Use Disorder and stimulant use disorders. With ten digital enhancements, it enables remote treatment and data collection, seamlessly transmitting information to healthcare providers through a secure, HIPAA-compliant portal.

CBOT with olfactory stimulants & OFC tasks

The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time combined with orbitofrontal cortex (OFC) dependent olfactory tasks.

CBOT Sham

CBOT Sham uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive olfactory tasks

Primary outcome measure

  • Retention in SUD treatment [ Time Frame: Baseline to day 14 ]
  • Retention in SUD treatment [ Time Frame: Baseline to day 28 ]
  • Retention in SUD treatment [ Time Frame: Baseline to 8 weeks ]
  • Retention in SUD treatment [ Time Frame: Baseline to three months ]
  • SUD Relapse Rate [ Time Frame: Baseline to day 7 ]
  • SUD Relapse Rate [ Time Frame: Baseline to day 14 ]
  • SUD Relapse Rate [ Time Frame: Baseline to day 28 ]
  • SUD Relapse Rate [ Time Frame: Baseline to 8 weeks ]
  • SUD Relapse Rate [ Time Frame: Baseline to three months ]
  • SUD engagement [ Time Frame: Baseline to day 14 ]

Central Contacts and Locations

Central contacts

Evaristus Nwulia, MD

410-227-2005enwulia@evonmedics.org

Opeyemi M Awofeso, MD

410-891-4007oawofeso@evonmedics.org

Locations

Clinics of Dr. Edwin Chapman @ MHDG

Recruiting

Washington, District of Columbia, United States, 20002

Howard University

Recruiting

Washington, District of Columbia, United States, 20060

More Information

Sponsor

Evon Medics LLC

Last update posted

May 30, 2024

Last verified

May, 2024

Keywords

  • Substance Abuse
  • Substance Use Disorder
  • Retention
  • Relapse
  • Chemosensory-Based Olfactory Networks Training
  • Remote Management

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Evon Medics LLC on 2024-05-30.