CBD for Dental Pain

• Status: Recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Health Science Center at San Antonio
• Treatments: Cannabidiol; Epidiolex

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.