Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT04642404
Eligibility Criteria:
Inclusion Criteria:
* Healthy adults 18-75 years old, ASA I or II
* permanent tooth with moderate to severe odontogenic pain, i.e. ≥30 on a 100mm VAS,
* clinical pulpal diagnosis of irreversible pulpitis or pulpal necrosis, and periapical diagnosis of symptomatic apical periodontitis
* test negative for recent cannabis use and/or other drugs of abuse including alcohol (urine tests collected at screening visit), and participant
* able to understand the forms (English or Spanish) and provide informed written consent.
Exclusion Criteria:
* ASA Class III or IV
* patients with hepatic impairment
* pregnant or lactating women
* Patients on drugs metabolized by enzymes that also metabolize CBD (e.g. clobazam, diazepam, topiramate, warfarin)
* self-reported prior experience inhaling cannabis (either via smoking or vaporization), use of opioids in the month prior to screening/treatment visit, and/or NSAIDS or acetaminophen 6 hours prior to treatment
* unwilling to participate.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04642404
Study Brief:
Protocol Section:
NCT04642404