Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder (CBOT-OUD)

EvOn Medics

Status and phase: Unknown; Phase 2

Conditions: Negative Affectivity; Withdrawal Symptoms; Craving; Opioid Use Disorder, Moderate; Opioid Use Disorder, Severe

Treatments: Drug: CBOT + TAU; Drug: Sham + TAU

Study type: Interventional

Funder types: Other; Industry; NIH

Identifiers

NCT04850664

2R44DA049616-02 (U.S. NIH Grant/Contract)

CBOTDA049616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 190 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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190 participants in 2 patient groups

CBOT + TAU

Experimental group

Description:

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).

Treatment:

Drug: CBOT + TAU

Sham + TAU

Sham Comparator group

Description:

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).

Treatment:

Drug: Sham + TAU