Clinical trial NCT04850664: Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Official title: Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Opioid Use Disorder, Moderate
Opioid Use Disorder, Severe
Withdrawal Symptoms
Craving
Negative Affectivity
Keywords: Opioid Use Disorders
Buprenorphine Maintenance Treatment
Orbitofrontal cortex (OFC)
CBOT
Relapse Prevention
Lead sponsor: Evon Medics LLC
Sponsor class: INDUSTRY
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Howard University
name: Family and Medical Counseling Service, Inc
name: Maryland Treatment Centers @ ARTC
name: Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
First posted: 2021-04-20
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 2 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 4 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 6 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 8 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 10 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 12 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 14 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 16 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 18 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 20 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 22 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 24 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 26 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 28 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 30 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 32 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 34 weeks after baseline
measure: 6-month buprenorphine maintenance treatment (BMT) retention
timeFrame: 36 weeks after baseline
measure: Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week
timeFrame: Screening to Week 12 Treatment
measure: Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24
timeFrame: Screening to Week 24
measure: Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month
timeFrame: Screening visit to Week 12
measure: Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month
timeFrame: Screening visit to Week 24
measure: Change from Screening in negative affect severity in the PANAS
timeFrame: Screening visit to Week 12
measure: Change from Screening in negative affect severity in the PANAS
timeFrame: Screening visit to Week 24
Secondary outcomes:
measure: Opioid Relapse
timeFrame: Screening visit to Week 12
measure: Pre-Intervention changes in SOWS from Screening at Week 2
timeFrame: Screening visit to Week 2
measure: Post-Intervention changes in SOWS from Week 12 at Week 13
timeFrame: Week 12 to Week 13
measure: Pre-Intervention changes in OCS from Screening to Week 2
timeFrame: Screening visit to Week 2
measure: Post-Intervention changes in OCS from Week 12 to Week 13
timeFrame: Week 12 to Week 13
measure: Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2
timeFrame: Screening visit to Week 2
measure: Post-Intervention changes in PANAS negative affect from Week 12 at Week 13
timeFrame: Week 12 to Week 13
Other outcomes:
Locations:
city: Washington
country: United States
facility: Clinics of Dr. Edwin Chapman @ MHDG
state: District of Columbia
city: Washington
country: United States
facility: Family and Medical Counseling Service, Inc
state: District of Columbia
city: Washington
country: United States
facility: Howard University
state: District of Columbia
city: Rockville
country: United States
facility: Maryland Treatment Centers @ Avery Road Treatment Center
state: Maryland
Study officials:
affiliation: Evon Medics LLC
name: Evaristus A Nwulia, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Howard University
name: Tanya Alim, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Howard University
name: Mark Johnson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Maryland Treatment Centers
name: Marc Fishman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Family and Medical Counseling Service, Inc
name: Michael Serlin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinics of Dr. Edwin C. Chapman, MD, PC @ MHDG
name: Edwin Chapman, MD
role: PRINCIPAL_INVESTIGATOR
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citation: Hummel T, Rissom K, Reden J, Hahner A, Weidenbecher M, Huttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101.