Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
NCT ID: NCT04850664
Last Updated: 2021-08-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
190 participants
INTERVENTIONAL
2021-03-26
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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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).
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 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).
Sham + TAU
Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
Howard University
OTHER
Family and Medical Counseling Service, Inc
UNKNOWN
Maryland Treatment Centers @ ARTC
UNKNOWN
Clinics of Dr. Edwin Chapman, MD, PC @ MHDG
UNKNOWN
Evon Medics LLC
INDUSTRY
Responsible Party
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Evaristus Awele Nwulia
Chief Scientific Officer
Principal Investigators
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Evaristus A Nwulia, MD
Role: PRINCIPAL_INVESTIGATOR
Evon Medics LLC
Tanya Alim, MD
Role: PRINCIPAL_INVESTIGATOR
Howard University
Mark Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Howard University
Marc Fishman, MD
Role: PRINCIPAL_INVESTIGATOR
Maryland Treatment Centers
Michael Serlin, MD
Role: PRINCIPAL_INVESTIGATOR
Family and Medical Counseling Service, Inc
Edwin Chapman, MD
Role: PRINCIPAL_INVESTIGATOR
Clinics of Dr. Edwin C. Chapman, MD, PC @ MHDG
Locations
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Clinics of Dr. Edwin Chapman @ MHDG
Washington D.C., District of Columbia, United States
Family and Medical Counseling Service, Inc
Washington D.C., District of Columbia, United States
Howard University
Washington D.C., District of Columbia, United States
Maryland Treatment Centers @ Avery Road Treatment Center
Rockville, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Settles-Reaves
Role: primary
Adenuga
Role: backup
Serlin
Role: primary
Jackson
Role: backup
Rai
Role: primary
Hipolito
Role: backup
Wenzel
Role: primary
Machineni
Role: backup
References
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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):160. doi: 10.4172/2471-2701.1000160. Epub 2017 Aug 15.
Volkow ND, Fowler JS. Addiction, a disease of compulsion and drive: involvement of the orbitofrontal cortex. Cereb Cortex. 2000 Mar;10(3):318-25. doi: 10.1093/cercor/10.3.318.
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.
Temple DM. Isolation techniques for pharmacologically active substances (animal). Annu Rev Pharmacol. 1969;9:407-18. doi: 10.1146/annurev.pa.09.040169.002203. No abstract available.
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.
Other Identifiers
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CBOTDA049616
Identifier Type: -
Identifier Source: org_study_id
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