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Cannabinoid

Epidiolex 100 mg/mL Oral Solution for Toothache

Phase 1 & 2
Waitlist Available
Led By Vanessa Chrepa, DDS MS
Research Sponsored by The University of Texas Health Science Center at San Antonio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 90 minutes and 180 minutes
Awards & highlights

Study Summary

This trial will test whether CBD can help relieve dental pain. Subjects will be given either CBD or a placebo, and then monitored for pain and psychological effects for 3 hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 90 minutes and 180 minutes
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 90 minutes and 180 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Bite Force Measurement
Intra-group VAS Pain Intensity and Maximum Pain Relief
Secondary outcome measures
Number of Participants With Adverse Events

Side effects data

From 2023 Phase 1 & 2 trial • 64 Patients • NCT04642404
29%
Sedation
14%
Fatigue
14%
Somnolence
14%
Diarrhea
10%
Headache
10%
Nausea
10%
Decreased appetite
5%
Abdominal pain
5%
Paresthesia
5%
Hot Flashes
5%
Angina
5%
Dry mouth
5%
Nasopharyngitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Epidiolex 10mg/kg Single Dose
Epidiolex 20mg/kg Single Dose
Placebo Group

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Epidiolex 20mg/kg single doseExperimental Treatment1 Intervention
The 20mg/kg dose is the maximum recommended daily dose from the manufacturer. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Group II: Epidiolex 10mg/kg single doseExperimental Treatment1 Intervention
After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Group III: Placebo groupPlacebo Group1 Intervention
Placebo drug will be a solution with the same taste, texture and color as the drug. After drug administration, subjects will be monitored for 3 hours, and pain intensity and safety data will be collected at various time points. Ibuprofen 600mg (or acetaminophen/codeine 650/60mg, if a contraindication for ibuprofen exists) will be provided in the 3-hour observation period as rescue medication if needed. Subjects will be encouraged to wait at least 60min after administration of the drug study before consuming the rescue medication. It will be given at the patient's request. If rescue medication was required, the study drug will still be dosed as per protocol, and time-to -rescue analysis will be performed. Then, the recommended root canal therapy will be performed the same or the next day.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Epidiolex 100 mg/mL Oral Solution
2021
Completed Phase 2
~70

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor
454 Previous Clinical Trials
90,712 Total Patients Enrolled
Vanessa Chrepa, DDS MSPrincipal Investigator - University of Texas Health Science Center San Antonio
The University of Texas Health Science Center at San Antonio
~15 spots leftby Jun 2025
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