RECRUITING

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

Conditions

Substance Use Disorders Opioid Use Disorder Alcohol Use Disorder Cocaine Use Disorder Methamphetamine-dependence Substance Abuse Substance Use Disorder Retention Relapse Chemosensory-Based Olfactory Networks Training Remote Management

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Development and Evaluation of Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR)

Quick Facts

Study Start:2023-07-07

Study Completion:2025-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06434818

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Evaristus Nwulia, MD

CONTACT

410-227-2005

enwulia@evonmedics.org

Opeyemi M Awofeso, MD

CONTACT

410-891-4007

oawofeso@evonmedics.org

Principal Investigator

Charles Nwaokobia

PRINCIPAL_INVESTIGATOR

Evon Medics LLC

Evaristus Nwulia, MD

PRINCIPAL_INVESTIGATOR

Evon Medics LLC

Tanya Alim, MD

PRINCIPAL_INVESTIGATOR

Howard University

Edwin Chapman, MD

PRINCIPAL_INVESTIGATOR

Clinics of Dr. Edwin Chapman at MHDG

Marc Fishman, MD

PRINCIPAL_INVESTIGATOR

Maryland Treatment Center

Study Locations (Sites)

Clinics of Dr. Edwin Chapman @ MHDG

Washington, District of Columbia, 20002

United States

Howard University

Washington, District of Columbia, 20060

United States

Maryland Treatment Center

Rockville, Maryland, 20853

United States

Collaborators and Investigators

Sponsor: Evon Medics LLC

Charles Nwaokobia, PRINCIPAL_INVESTIGATOR, Evon Medics LLC
Evaristus Nwulia, MD, PRINCIPAL_INVESTIGATOR, Evon Medics LLC
Tanya Alim, MD, PRINCIPAL_INVESTIGATOR, Howard University
Edwin Chapman, MD, PRINCIPAL_INVESTIGATOR, Clinics of Dr. Edwin Chapman at MHDG
Marc Fishman, MD, PRINCIPAL_INVESTIGATOR, Maryland Treatment Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-07

Study Completion Date2025-06-30

Study Record Updates

Study Start Date2023-07-07

Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Substance Use Disorders
Opioid Use Disorder
Alcohol Use Disorder
Cocaine Use Disorder
Methamphetamine-dependence