Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Status unconfirmed · Phase 2 · Has a placebo group
Conditions studied: Opioid Use Disorder, Moderate, Opioid Use Disorder, Severe, Withdrawal Symptoms, Craving, Negative Affectivity
In brief
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.
Key facts
- Study ID
- NCT04850664
- Run by
- Evon Medics LLC
- People needed
- 190
- Starts
- 2021-03-26
- Expected to finish
- 2022-12-31
- Last updated by the study team
- 2021-08-06
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Clinics of Dr. Edwin Chapman @ MHDG — Washington D.C., District of Columbia, United States (enrolling)
- Family and Medical Counseling Service, Inc — Washington D.C., District of Columbia, United States (enrolling)
- Howard University — Washington D.C., District of Columbia, United States (enrolling)
- Maryland Treatment Centers @ Avery Road Treatment Center — Rockville, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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