UnknownPhase 2

Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder

United States190 participantsStarted 2021-03-26

Plain-language summary

Opioid Use Disorders (OUD) cause significant burden to individuals, families, and the society. Our product - Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) - offers a cost-saving, home-based, user-friendly brain stimulation system that increased 6-month treatment retention of OUDs in a pilot study; and also, acutely reduced opioid withdrawal severity and negative affect during induction into opioid maintenance therapy. This study will establish its effectiveness in a broad category of OUD subjects at different stages of OUD care continuum.

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18- 70years * Diagnosis of current moderate or severe OUD in the past 6 months, including the past one month * Willing to receive study interventions and buprenorphine during the study * Do not meet criteria for current moderate or severe use of other substance use disorders (except nicotine use disorder) * Diagnosis of Major Depressive Disorder, Anxiety disorders, and Post-traumatic Stress disorders will be included as long as the symptoms are stable, no suicidal ideas or plans and there are no recent changes in treatment of these conditions in the last 6 weeks prior to enrollment * No intranasal disease * Willing to participate by signing the informed consent form and * Have a place to stay when receiving the intervention. Exclusion Criteria: * Any significant neurologic disease such as stroke, dementia, meningitis, neurosyphilis, cerebral palsy, encephalitis, epilepsy or seizures * Mental retardation * Schizophrenia or bipolar disorders * Experiencing current suicide ideas or plans * Any unstable medical condition such as uncontrolled hypertension, uncontrolled diabetes, and liver cirrhosis, as determined by site PI * History of severe traumatic nose injury that affects ability to smell, as determined by site PI * Allergies or intolerance to aromas from plant essential oils (e.g. orange and lemon) * Breastfeeding or Pregnancy test positive. * On parole or probation mandated to receive treatment for OUD.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 2 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 4 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 6 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 8 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 10 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 12 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 14 weeks after baseline

Trial details

NCT IDNCT04850664

SponsorEvon Medics LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-30

Contact for this trial

Evaristus A Nwulia, MD, MHS

410-227-2005 enwulia@evonmedics.org

View on ClinicalTrials.gov More Opioid Use Disorder, Moderate trials

Plain-language summary

Who can participate

Age range

18 Years – 70 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 2 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 4 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 6 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 8 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 10 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 12 weeks after baseline

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 14 weeks after baseline