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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

Summary

This trial is testing Epidiolex, a CBD-based medicine, to see if it can help people with emergency dental pain. CBD can reduce pain and swelling without causing a high or addiction. Epidiolex is an approved formulation of CBD oil available by prescription in the United States, primarily used for treating some types of refractory epilepsy in children.

Eligible Conditions

Toothache

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 90 minutes and 180 minutes

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bite Force Measurement

Intra-group VAS Pain Intensity and Maximum Pain Relief

Secondary study objectives

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%

Decreased appetite

10%

Nausea

Dry mouth

Abdominal pain

Nasopharyngitis

Paresthesia

Hot Flashes

Angina

100%

80%

60%

40%

20%

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

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