Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Evon Medics will perform randomization of participants stratified by sex at site level. Site staff and participants will be blinded to treatment assignment.
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CBOT + TAU
CBOT consists of 40 cycles of olfactory stimulation and OFC training tasks, lasting ~45 minutes, once daily over 3 months. Treatment-as-usual (TAU) is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).
  • Drug: CBOT + TAU
    The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time. It is paired with OFC-dependent cognitive tasks.
    Other names:
    • plant based essential oils
Sham Comparator
Sham + TAU
Sham is a CBOT device that uses artificially-scented compressed room air instead of olfactory stimulants and has no OFC cognitive tasks. Similar to the CBOT, sham will be used daily for 45 minutes. TAU is standard dosing of buprenorphine (BUP) to a median dose of 24 mg (range 16-32 mg).
  • Drug: Sham + TAU
    Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.

Recruiting Locations

Howard University
Washington, District of Columbia 20060
Contact:
Rai

More Details

Status
Unknown status
Sponsor
Evon Medics LLC

Study Contact

Evaristus A Nwulia, MD, MHS
410-227-2005
enwulia@evonmedics.org

Detailed Description

Evon Medics proposes to evaluate the effectiveness of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT), as an alternative strategy for relapse prevention in patients with Opioid Use (OUD) and other substance use disorders (SUD). This treatment leverages the overlap in brain regions that process smell and mediate decision making. The CBOT is portable and can be used at home. This clinical trial is being conducted to demonstrate its utility for home application by nontreatment seeking and treatment-seeking OUD populations, to engage in long-term, successful opioid recovery. Key objectives of this project are to: (1) establish the effectiveness of CBOT for improved retention and relapse prevention in a large sample of OUD subjects; (2) establish its effectiveness for acute reduction of withdrawal severity and negative affect early in recovery; and (3) evaluate its safety, user-friendliness and acceptability. Accomplishment of these goals would lead to larger clinical trials for OUD and wider applications of CBOT in other addictive disorders.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.