Clinical trial NCT06434818: Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders
Official title: Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Substance Use Disorders
Opioid Use Disorder
Alcohol Use Disorder
Cocaine Use Disorder
Methamphetamine-dependence
Keywords: Substance Abuse
Substance Use Disorder
Retention
Relapse
Chemosensory-Based Olfactory Networks Training
Remote Management
Lead sponsor: Evon Medics LLC
Sponsor class: INDUSTRY
Collaborators: name: Howard University
name: Maryland Treatment Center
name: Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
name: National Institute on Drug Abuse (NIDA)
First posted: 2024-05-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Retention in SUD treatment
timeFrame: Baseline to day 14
measure: Retention in SUD treatment
timeFrame: Baseline to day 28
measure: Retention in SUD treatment
timeFrame: Baseline to 8 weeks
measure: Retention in SUD treatment
timeFrame: Baseline to three months
measure: SUD Relapse Rate
timeFrame: Baseline to day 7
measure: SUD Relapse Rate
timeFrame: Baseline to day 14
measure: SUD Relapse Rate
timeFrame: Baseline to day 28
measure: SUD Relapse Rate
timeFrame: Baseline to 8 weeks
measure: SUD Relapse Rate
timeFrame: Baseline to three months
measure: SUD engagement
timeFrame: Baseline to day 14
Secondary outcomes:
measure: Opioid Craving Scale (OCS)
timeFrame: Baseline to Day 7
measure: Cocaine Craving Questionnaire-Brief (CCQ-Brief)
timeFrame: Baseline to day 7
measure: Self-report instruments for Alcohol Craving
timeFrame: Baseline to day 7
measure: Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: Baseline to day 7
measure: Positive and Negative Affect Scales (PANAS)
timeFrame: Baseline to day 7
measure: Opioid Craving Scale (OCS)
timeFrame: Baseline to day 14
measure: Cocaine Craving Questionnaire-Brief (CCQ-Brief)
timeFrame: Baseline to day 14
measure: Self-report instruments for Alcohol Craving
timeFrame: Baseline to day 14
measure: Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: Baseline to day 14
measure: Positive and Negative Affect Scales (PANAS)
timeFrame: Baseline to day 14
measure: Opioid Craving Scale (OCS)
timeFrame: Baseline to Day 28
measure: Cocaine Craving Questionnaire-Brief (CCQ-Brief)
timeFrame: Baseline to day 28
measure: Self-report instruments for Alcohol Craving
timeFrame: Baseline to day 28
measure: Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: Baseline to day 28
measure: Positive and Negative Affect Scales (PANAS)
timeFrame: Baseline to day 28
measure: Addiction Severity Index (ASI)
timeFrame: Baseline to day 28
measure: Opioid Craving Scale (OCS)
timeFrame: Baseline to 8 weeks
measure: Cocaine Craving Questionnaire-Brief (CCQ-Brief)
timeFrame: Baseline to 8 weeks
measure: Self-report instruments for Alcohol Craving
timeFrame: Baseline to 8 weeks
measure: Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: Baseline to 8 weeks
measure: Positive and Negative Affect Scales (PANAS)
timeFrame: Baseline to 8 weeks
measure: Addiction Severity Index (ASI)
timeFrame: Baseline to 8 weeks
measure: Opioid Craving Scale (OCS)
timeFrame: Baseline to three months
measure: Cocaine Craving Questionnaire-Brief (CCQ-Brief)
timeFrame: Baseline to three months
measure: Self-report instruments for Alcohol Craving
timeFrame: Baseline to three months
measure: Subjective Opioid Withdrawal Scale (SOWS)
timeFrame: Baseline to three months
measure: Positive and Negative Affect Scales (PANAS)
timeFrame: Baseline to three months
measure: Addiction Severity Index (ASI)
timeFrame: Baseline to three months
Other outcomes:
Locations:
city: Washington
country: United States
facility: Clinics of Dr. Edwin Chapman @ MHDG
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Rockville
country: United States
facility: Maryland Treatment Center
state: Maryland
Study officials:
affiliation: Evon Medics LLC
name: Charles Nwaokobia
role: PRINCIPAL_INVESTIGATOR
affiliation: Evon Medics LLC
name: Evaristus Nwulia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Howard University
name: Tanya Alim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinics of Dr. Edwin Chapman at MHDG
name: Edwin Chapman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maryland Treatment Center
name: Marc Fishman, MD
role: PRINCIPAL_INVESTIGATOR
References: