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 range18 Years – 70 Years

SexALL

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.

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

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 16 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 range18 Years – 70 Years

SexALL

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

6-month buprenorphine maintenance treatment (BMT) retention

Timeframe: 16 weeks after baseline