Digital olfactory training for managing substance use disorders

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

This study is testing a new digital smell training device to see if it can help adults with substance use disorders stay in treatment and stay sober better than regular treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Evon Medics LLC (industry)
• Locations: 3 sites (Washington D.C., District of Columbia and 2 other locations)
• Trial ID: NCT06434818 on ClinicalTrials.gov

What this trial studies

This study evaluates the Enhanced Digital-Chemosensory-Based Olfactory Training for Remote Management of Substance Use Disorders (EDITOR) device in clinics treating substance use disorders. It aims to compare the effectiveness of this novel digital intervention against standard treatment and another active control device. The study will involve 300 adult patients with opioid, alcohol, or stimulant use disorders, assessing outcomes such as treatment retention and abstinence. Additionally, it will explore the integration of machine learning algorithms to enhance treatment personalization.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18-80 with moderate to severe substance use disorders involving opioids, alcohol, or stimulants.

Not a fit: Patients with significant neurological diseases or those not meeting the specific substance use disorder criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve treatment outcomes for patients with substance use disorders by providing effective remote management options.

How similar studies have performed: While the approach is innovative, there is limited existing evidence on the effectiveness of similar digital olfactory training methods for substance use disorders.

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.

Where this trial is running

Washington D.C., District of Columbia and 2 other locations

• Clinics of Dr. Edwin Chapman @ MHDG — Washington D.C., District of Columbia, United States (RECRUITING)
• Howard University — Washington D.C., District of Columbia, United States (RECRUITING)
• Maryland Treatment Center — Rockville, Maryland, United States (ENROLLING_BY_INVITATION)

Study contacts

• Principal investigator: Charles Nwaokobia — Evon Medics LLC
• Study coordinator: Evaristus Nwulia, MD

Conditions: Substance Use Disorders, Opioid Use Disorder, Alcohol Use Disorder, Cocaine Use Disorder, Methamphetamine-dependence, Substance Abuse, Substance Use Disorder, Retention