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

Last updated: May 22, 2024
Sponsor: Evon Medics LLC
Overall Status: Active - Recruiting

Phase

2

Condition

Mood Disorders

Alcohol Dependence

Substance Abuse

Treatment

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

CBOT with olfactory stimulants & OFC tasks

CBOT Sham

Clinical Study ID

NCT06434818
EDITDA056156
4R44DA056156-02
  • Ages 18-80
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18 - 80 years, inclusive at enrollment.

  2. Diagnosis of current moderate or severe substance use disorders, opioid usedisorders, stimulant (cocaine and methamphetamine) use, and alcohol use disorders inthe past three months, including the past month.

  3. Does not meet criteria for other current SUDs outside of the 3 above, except formild or moderate use of cannabis

  4. Willing to receive study interventions and buprenorphine (for OUD group) andnaltrexone (for AUD group) during the study

  5. Females must not be pregnant at enrollment and agree not to become pregnant duringthe 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 whenreceiving the intervention and during the entire duration of the studyparticipation.

Exclusion

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, andsuicidal risk. Diagnosis of major depressive disorders, anxiety disorders, andpost-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 ofthese conditions in the 6 weeks prior to enrollment.

  4. Experiencing current suicide ideas or plans.

  5. Any unstable medical condition such as uncontrolled hypertension, uncontrolleddiabetes, or liver cirrhosis as determined by the site PI.

  6. History of severe traumatic nose injury that affects the ability to smell orsignificant intranasal disease, as determined by the site PI.

  7. Known allergies or intolerance to aromas from plant essential oils. E.g., orange andlemon.

  8. Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 monthsfollowing enrollment.

  9. Individuals who are on parole or probation.

Study Design

Total Participants: 300
Treatment Group(s): 3
Primary Treatment: EDITOR (CBOT with olfactory stimulants, OFC tasks & remote monitoring of treatment compliance)
Phase: 2
Study Start date:
July 07, 2023
Estimated Completion Date:
June 30, 2025

Study Description

The Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) is a project to develop a sustainable, scalable, and patient-centered mobile health platform, comprised of (1) a patient-facing culturally-adapted digital chemosensory therapeutic for stimulant, alcohol and opioid use disorders, sensors for acquisition of objective physiological measures of substance intoxication and withdrawal, and an application for running and interpreting the interventions and sensory acquisition programs; and (2) a provider-facing web portal, for substance use disorder treatment in socially disadvantaged and sexual minority populations.

The small business, Evon Medics implemented the use of the EDITOR device as a novel approach for remote management of substance use disorders (SUDs) amid the challenges of the COVID-19 pandemic. Management of SUD mostly involve direct contact between patients and providers, but the precedence of COVID-19 pandemic has elevated the need for patient-centered remote management of SUD. While digital therapeutics and mobile health platforms provide avenues for remote management, communities of African Americans (AA), Hispanic Americans (HA) and other socially disadvantaged populations lag in adoption of these mobile platforms, due to inability to read, digital illiteracy, lack of access to smartphones, absence of reliable Wi-Fi or internet, and financial constraints. Moreover, while interventions exist for OUD, there are no drugs for cocaine or stimulant use disorders. Underserved AA and HA communities with OUD, particularly marginalized men who have sex with men (MSM), have more severe co-existing cocaine, methamphetamine, and alcohol use disorders; and digital solutions for these populations are lacking. Providers on the other hand, lack well-adapted, intelligent-based physiological and psychophysical acquisition platforms to guide remote agonist management of opioid and alcohol withdrawal.

EVON Medics developed a combinatorial digital chemosensory-based orbitofrontal cortex training for Opioid Use Disorder (CBOT). Based on the limitations of CBOT for the socially disadvantaged AA, HA and MSM population, the investigators recently revised the platform for treatment of stimulant and alcohol use disorder, by including beta-caryophyllene chemosensory stimulation. Further product development, with innovative changes to the patient-facing platform and a new provider-facing platform to guide remote management of OUD, stimulant (cocaine and methamphetamine) use and alcohol use disorders were preliminary tested (Phase I) in affiliated substance use community programs and community populations in the under-served communities in Washington, DC and Maryland.

In this study phase, Phase II of this Fast-Track SBIR application, the investigators will conduct a pilot randomized trial of EDITOR compared to treatment as usual and CBOT for office-based treatment of SUDs in several federal funded programs associated with Evon Medics and Howard University, to assess EDITOR's effectiveness in improving treatment retention, reducing relapses, and mitigating SUD severity, and offering a promising solution for home-based SUD treatment.

Connect with a study center

  • Clinics of Dr. Edwin Chapman @ MHDG

    Washington, District of Columbia 20002
    United States

    Active - Recruiting

  • Howard University

    Washington, District of Columbia 20060
    United States

    Active - Recruiting

  • Maryland Treatment Center

    Rockville, Maryland 20853
    United States

    Site Not Available

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