CBD for Dental Pain

Toothache Clinical Trial

Official title:

Cannabidiol (CBD) for the Management of Emergency Dental Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642404
• Other study ID #: HSC20200305H
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: March 1, 2021
• Est. completion date: March 13, 2023

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center at San Antonio
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: March 13, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Odontalgia
• Toothache

Intervention

Drug:
• Epidiolex 100 mg/mL Oral Solution
Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
• Placebo
Placebo drug will be a solution with the same taste, texture and color as the drug.

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center at San Antonio

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra-group VAS Pain Intensity and Maximum Pain Relief	Patients will report their pain level using a 100mm Visual Analogue Scale at baseline, measured at baseline and 180 minutes. Score is measured on a 100mm scale, scored 0-100, with a lower score indicating less pain.	Baseline to 180 minutes
Primary	Bite Force Measurement	Bite force is measured by biting down on the Bite Fork at various times to measure change in value. The digital bite transducer is a previously validated instrument used to assess changes in the bite forces (N) before and after the intervention.	Baseline, 90 minutes and 180 minutes
Secondary	Number of Participants With Adverse Events	Included: Psychoactive effects, mood changes, and report other side effects after single dose of Epidiolex	3 hours and 7 Days