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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 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. Who Should NOT Join This Trial: 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

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.

COMBINATION_PRODUCT

CBOT Sham

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

Locations (3)

Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Maryland Treatment Center
Rockville, Maryland, United States