Clinical trial · Interventional
Computerized Chemosensory-Based Orbitofrontal Cortex (CBOT) for Opioid Use Disorder
Development and Evaluation of Computerized Chemosensory-Based Orbitofrontal Cortex Training (CBOT) for Opioid Use Disorder
NCT04850664CI-TRIAL-00053137CBOT-OUDunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Craving | — | UNRESOLVED | — |
| Negative Affectivity | — | UNRESOLVED | — |
| Opioid Use Disorder, Moderate | — | UNRESOLVED | — |
| Opioid Use Disorder, Severe | — | UNRESOLVED | — |
| Withdrawal Symptoms | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBOT + TAU | Drug | — | UNRESOLVED |
| Sham + TAU | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CBOT + TAU
- 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).
- interventionNames
- Drug: CBOT + TAU
- type
- SHAM_COMPARATOR
- label
- Sham + TAU
- 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).
- interventionNames
- Drug: Sham + TAU
Primary outcomes (24)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDJackson 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. PMID 29057388
- BACKGROUNDVolkow 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. PMID 10731226
- BACKGROUNDLucantonio 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. PMID 25042581
- BACKGROUNDTemple 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. PMID 4894805
- BACKGROUNDHummel 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. PMID 19235739