Recruiting
Phase 2

CBOT

Sponsor:

Evon Medics LLC

Code:

NCT04850664

Conditions

Opioid Use Disorder, Moderate

Opioid Use Disorder, Severe

Withdrawal Symptoms

Craving

Negative Affectivity

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

CBOT + TAU

Sham + TAU

Study Details

Brief 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.

Conditions

Opioid Use Disorder, Moderate

Opioid Use Disorder, Severe

Withdrawal Symptoms

Craving

Negative Affectivity

Study ID

NCT04850664

Start date

Mar 26, 2021

Status verified date

Jul, 2021

Completion date

Dec 31, 2022

Anticipated

Primary completion date

Nov 30, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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

Enrollment

190 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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).

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).

Interventions

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.

Sham + TAU

Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.

Primary outcome measure

  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 2 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 4 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 6 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 8 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 10 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 12 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 14 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 16 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 18 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 20 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 22 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 24 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 26 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 28 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 30 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 32 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 34 weeks after baseline ]
  • 6-month buprenorphine maintenance treatment (BMT) retention [ Time Frame: 36 weeks after baseline ]
  • Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week [ Time Frame: Screening to Week 12 Treatment ]
  • Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24 [ Time Frame: Screening to Week 24 ]
  • Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month [ Time Frame: Screening visit to Week 12 ]
  • Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month [ Time Frame: Screening visit to Week 24 ]
  • Change from Screening in negative affect severity in the PANAS [ Time Frame: Screening visit to Week 12 ]
  • Change from Screening in negative affect severity in the PANAS [ Time Frame: Screening visit to Week 24 ]

Central Contacts and Locations

Central contacts

Evaristus A Nwulia, MD, MHS

410-227-2005enwulia@evonmedics.org

Maria M Hipolito, MD

571-241-2766mhipolito@evonmedics.org

Locations

Clinics of Dr. Edwin Chapman @ MHDG

Recruiting

Washington, District of Columbia, United States, 20002

Principal Investigator:

Edwin Chapman, MD

Family and Medical Counseling Service, Inc

Recruiting

Washington, District of Columbia, United States, 20020

Principal Investigator:

Michael Serlin, MD

Howard University

Recruiting

Washington, District of Columbia, United States, 20060

Principal Investigator:

Tanya N Alim, MD

Maryland Treatment Centers @ Avery Road Treatment Center

Recruiting

Rockville, Maryland, United States, 20853

Principal Investigator:

Marc Fishman, MD

More Information

Sponsor

Evon Medics LLC

Last update posted

Aug 6, 2021

Last verified

Jul, 2021

Keywords

  • Opioid Use Disorders
  • Buprenorphine Maintenance Treatment
  • Orbitofrontal cortex (OFC)
  • CBOT
  • Relapse Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Evon Medics LLC on 2021-08-06.