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

Craving Clinical Trial

— CBOT-OUD  

Official title:

Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850664
• Other study ID #: CBOTDA049616
• Secondary ID: 2R44DA049616-02
• Status: Recruiting
• Phase: Phase 2
• Start date: March 26, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2021
• Source: Evon Medics LLC
• Contact: Evaristus A Nwulia, MD, MHS
• Phone: 410-227-2005
• Email: enwulia[@]evonmedics.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: December 31, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Craving
• Disease
• Negative Affectivity
• Opioid Use Disorder, Moderate
• Opioid Use Disorder, Severe
• Substance Withdrawal Syndrome
• Substance-Related Disorders
• Withdrawal Symptoms

Intervention

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

Locations

Country	Name	City	State
United States	Maryland Treatment Centers @ Avery Road Treatment Center	Rockville	Maryland
United States	Clinics of Dr. Edwin Chapman @ MHDG	Washington	District of Columbia
United States	Family and Medical Counseling Service, Inc	Washington	District of Columbia
United States	Howard University	Washington	District of Columbia

Sponsors (6)

Lead Sponsor	Collaborator
Evon Medics LLC	Clinics of Dr. Edwin Chapman, MD, PC @ MHDG, Family and Medical Counseling Service, Inc, Howard University, Maryland Treatment Centers @ ARTC, National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

References & Publications (5)

Hummel T, Rissom K, Reden J, Hähner A, Weidenbecher M, Hüttenbrink KB. Effects of olfactory training in patients with olfactory loss. Laryngoscope. 2009 Mar;119(3):496-9. doi: 10.1002/lary.20101. — View Citation

Jackson C, Rai N, McLean CK, Hipolito MMS, Hamilton FT, Kapetanovic S, Nwulia EA. Overlapping Risky Decision-Making and Olfactory Processing Ability in HIV-Infected Individuals. Clin Exp Psychol. 2017 Sep;3(3). pii: 160. doi: 10.4172/2471-2701.1000160. Epub 2017 Aug 15. — View Citation

Lucantonio F, Takahashi YK, Hoffman AF, Chang CY, Bali-Chaudhary S, Shaham Y, Lupica CR, Schoenbaum G. Orbitofrontal activation restores insight lost after cocaine use. Nat Neurosci. 2014 Aug;17(8):1092-9. doi: 10.1038/nn.3763. Epub 2014 Jul 20. Erratum in: Nat Neurosci. 2014 Sep;17(9):1287. — View Citation

Temple DM. Isolation techniques for pharmacologically active substances (animal). Annu Rev Pharmacol. 1969;9:407-18. Review. — View Citation

Volkow ND, Fowler JS. Addiction, a disease of compulsion and drive: involvement of the orbitofrontal cortex. Cereb Cortex. 2000 Mar;10(3):318-25. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	2 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	4 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	6 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	8 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	10 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	12 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	14 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	16 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	18 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	20 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	22 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	24 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	26 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	28 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	30 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	32 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	34 weeks after baseline
Primary	6-month buprenorphine maintenance treatment (BMT) retention	6-month BMT retention is defined as missing two consecutive clinic visits after completing the first two weeks of BMT treatment, to allow for BUP dose stabilization.; Ascertainment of retention is simply by tracking clinic visits and electronic record of the health visit.	36 weeks after baseline
Primary	Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at week	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.	Screening to Week 12 Treatment
Primary	Change from Screening in Subjective Opiate Withdrawal Scale (SOWS) at Week 24	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely), and takes less than 10 minutes to complete.	Screening to Week 24
Primary	Change from Screening in Opioid Craving Scale (OCS) at Week 12 severity rating measures over 1 month	he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.	Screening visit to Week 12
Primary	Change from Screening in Opioid Craving Scale (OCS) at Week 24 severity rating measures over 1 month	he Opioid Craving Scale, a modification of the Cocaine Craving Scale was used to measure opioid craving.	Screening visit to Week 24
Primary	Change from Screening in negative affect severity in the PANAS	The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.	Screening visit to Week 12
Primary	Change from Screening in negative affect severity in the PANAS	The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.	Screening visit to Week 24
Secondary	Opioid Relapse	Relapse is defined as presence of self-reported repeated (i.e. 2 or more) use after the first two weeks for stabilization of buprenorphine dose, and/or presence of positive urine drug test for opiates. Ascertainment of opioid relapse is through: (a) Survey question administered 2-weekly, inquiring how days in the past did the subject use heroin, prescription opiates and/or other drugs; the dates of drug use; and the quantity (or dose) of drugs used; and (b) Biochemical verification of drug use, through urine samples will be collected and tested every two weeks.	Screening visit to Week 12
Secondary	Pre-Intervention changes in SOWS from Screening at Week 2	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).	Screening visit to Week 2
Secondary	Post-Intervention changes in SOWS from Week 12 at Week 13	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely).	Week 12 to Week 13
Secondary	Pre-Intervention changes in OCS from Screening to Week 2	a modification of the Cocaine Craving Scale was used to measure opioid craving.	Screening visit to Week 2
Secondary	Post-Intervention changes in OCS from Week 12 to Week 13	a modification of the Cocaine Craving Scale was used to measure opioid craving.	Week 12 to Week 13
Secondary	Pre-Intervention changes in PANAS negative affect from Screening visit to Week 2	The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.	Screening visit to Week 2
Secondary	Post-Intervention changes in PANAS negative affect from Week 12 at Week 13	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The Positive and Negative Affect Schedule (PANAS) is the most widely and frequently used scale to assess positive and negative affect.	Week 12 to Week 13