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

NCT06434818 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: EDITDA0561564R44DA056156-02
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

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

Keywords

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

Outcome Measures

Primary Outcomes (10)

• Retention in SUD treatment

  3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  Baseline to day 14

• Retention in SUD treatment

  3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  Baseline to day 28

• Retention in SUD treatment

  3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  Baseline to 8 weeks

• Retention in SUD treatment

  3-month retention in SUD treatment, is defined as missing two consecutive clinic visits after completing the first two weeks of SUD treatment; the rationale is to allow for buprenorphine (BUP) dose stabilization in those with opiate use disorder (OUD). Investigators found that missing two visits strongly correlated with self-reported relapse, positive drug urine screen, and non-adherence to the buprenorphine. Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.

  Baseline to three months

• SUD Relapse Rate

  Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  Baseline to day 7

• SUD Relapse Rate

  Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  Baseline to day 14

• SUD Relapse Rate

  Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  Baseline to day 28

• SUD Relapse Rate

  Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  Baseline to 8 weeks

• SUD Relapse Rate

  Relapse is defined as presence of self-reported repeat (i.e., 2 or more) specific substance use after the first week, and/or presence of positive urine drug test for opiates. Ascertainment of relapse is through: 1. survey question administered weekly, inquiring how many days in the past 1 week did the subject use drugs or alcohol; the dates of substance use; and the quantity (or dose) of drugs used; and 2. biochemical verification of drug use from urine samples collected and tested every two weeks.

  Baseline to three months

• SUD engagement

  SUD engagement is the proportion of people treated at baseline who complete the first two weeks of treatment.

  Baseline to day 14

Secondary Outcomes (28)

• Opioid Craving Scale (OCS)

  Baseline to Day 7

• Cocaine Craving Questionnaire-Brief (CCQ-Brief)

  Baseline to day 7

• Self-report instruments for Alcohol Craving

  Baseline to day 7

• Subjective Opioid Withdrawal Scale (SOWS)

  Baseline to day 7

• Positive and Negative Affect Scales (PANAS)

  Baseline to day 7

Study Arms (3)

Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)

EXPERIMENTAL

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).

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

Chemosensory-Based Olfactory Training (CBOT)

ACTIVE COMPARATOR

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

Combination Product: CBOT with olfactory stimulants & OFC tasks

Chemosensory-Based Olfactory Training (CBOT) Sham

SHAM COMPARATOR

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.

Combination Product: CBOT Sham

Interventions

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

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.

Also known as: EDITOR plus Treatment-As-Usual (TAU)

Enhanced Digital-Chemosensory-Based Olfactory Training (EDITOR)

CBOT with olfactory stimulants & OFC tasks COMBINATION_PRODUCT

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.

Also known as: CBOT active plus TAU

Chemosensory-Based Olfactory Training (CBOT)

CBOT Sham COMBINATION_PRODUCT

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

Also known as: CBOT passive plus TAU

Chemosensory-Based Olfactory Training (CBOT) Sham

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 - 80 years, inclusive at enrollment.
• 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.
• Does not meet criteria for other current SUDs outside of the 3 above, except for mild or moderate use of cannabis
• Willing to receive study interventions and buprenorphine (for OUD group) and naltrexone (for AUD group) during the study
• Females must not be pregnant at enrollment and agree not to become pregnant during the trial, through scientifically valid ways of contraception
• Willing to sign the informed consent form.
• 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.

You may not qualify if:

• Any significant neurological disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy, or seizures.
• Mental retardation.
• 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.
• Experiencing current suicide ideas or plans.
• Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, or liver cirrhosis as determined by the site PI.
• History of severe traumatic nose injury that affects the ability to smell or significant intranasal disease, as determined by the site PI.
• Known allergies or intolerance to aromas from plant essential oils. E.g., orange and lemon.
• Breastfeeding or pregnancy test positive or plans to get pregnant in the 6 months following enrollment.
• Individuals who are on parole or probation.

Sponsors & Collaborators

• Evon Medics LLC: lead
• Howard University: collaborator
• Maryland Treatment Center: collaborator
• Clinics of Dr. Edwin Chapman, MD, PC @ MHDG: collaborator
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (3)

Clinics of Dr. Edwin Chapman @ MHDG

Washington D.C., District of Columbia, 20002, United States

RECRUITING

Howard University

Washington D.C., District of Columbia, 20060, United States

RECRUITING

Maryland Treatment Center

Rockville, Maryland, 20853, United States

ENROLLING BY INVITATION

MeSH Terms

Conditions

Substance-Related Disorders; Opioid-Related Disorders; Alcoholism; Recurrence

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Narcotic-Related Disorders; Alcohol-Related Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Charles Nwaokobia

  Evon Medics LLC

  PRINCIPAL INVESTIGATOR

• Evaristus Nwulia, MD

  Evon Medics LLC

  PRINCIPAL INVESTIGATOR

• Tanya Alim, MD

  Howard University

  PRINCIPAL INVESTIGATOR

• Edwin Chapman, MD

  Clinics of Dr. Edwin Chapman at MHDG

  PRINCIPAL INVESTIGATOR

• Marc Fishman, MD

  Maryland Treatment Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evaristus Nwulia, MD

CONTACT

410-227-2005; enwulia@evonmedics.org

Opeyemi M Awofeso, MD

CONTACT

410-891-4007; oawofeso@evonmedics.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2024
• First Posted: May 30, 2024
• Study Start: July 7, 2023
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: May 30, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)