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NCT04850664: CBOT-OUD

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

Status unknown Phase 2 Last updated 6 August 2021
What this trial tests

Phase 2 trial testing CBOT + TAU in Opioid Use Disorder, Moderate in 190 participants. Status unknown.

Timeline
26 March 2021
Primary endpoint
30 November 2022
31 December 2022

Quick facts

Lead sponsorEvon Medics LLC
PhasePhase 2
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment190
Start date26 March 2021
Primary completion30 November 2022
Estimated completion31 December 2022
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Evon Medics LLC — full company profile →

Who can join

Adults 18 to 70, any sex, with Opioid Use Disorder, Moderate or Opioid Use Disorder, Severe. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Trends of Decentralized Clinical Trials Using Digital Technology for Decentralization
    Sato T, Mizumoto S, Ota M, Shikano M. · · 2022 · DOI 10.2139/ssrn.4243284

Verify or expand the search:

Other recruiting trials for Opioid Use Disorder, Moderate

Currently open trials in the same condition.

Other Evon Medics LLC trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04850664.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing