CBD for Dental Pain

  • STATUS
    Recruiting
  • End date
    Dec 22, 2023
  • participants needed
    60
  • sponsor
    The University of Texas Health Science Center at San Antonio
Updated on 22 April 2022
chronic pain

Summary

The purpose of this study is to evaulate CBD as a therapeutic approach for dental pain. Eligible subjects presented with emergency dental pain will be give a single dose of Epidiolex (FDA-approved CBD) or placebo and will be monitored for 3 hours for pain symptoms and psychologic effects.

Description

CBD is a non-psychoactive, non-addictive compound of cannabis that has shown analgesic and anti-inflammatory properties. Epidiolex is the only FDA-approved oral CBD solution and will be the drug of choice in this study.

Details
Condition Odontalgia, Toothache
Treatment Placebo, Epidiolex 100 mg/mL Oral Solution
Clinical Study IdentifierNCT04642404
SponsorThe University of Texas Health Science Center at San Antonio
Last Modified on22 April 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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