CBD for Dental Pain

Phase 1

Completed

• Conditions: Odontalgia; Toothache
• Interventions: Drug: Epidiolex 100 mg/mL Oral Solution; Drug: Placebo

• Registration Number: NCT04642404
• Lead Sponsor: The University of Texas Health Science Center at San Antonio

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-11-19
• Study First Submitted QC: 2020-11-19
• Study First Posted: 2020-11-24
• Study Start: 2021-03-01
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-13
• Results First Submitted: 2024-03-20
• Results First Submitted QC: 2024-03-20
• Status Verified: 2024-04
• Results First Posted: 2024-04-17
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epidiolex 10mg/kg single dose	Epidiolex 100 mg/mL Oral Solution	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.
Epidiolex 20mg/kg single dose	Epidiolex 100 mg/mL Oral Solution	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.
Placebo group	Placebo	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.

Primary Outcome Measures

Name	Time	Method
Intra-group VAS Pain Intensity and Maximum Pain Relief	Baseline to 180 minutes	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.
Bite Force Measurement	Baseline, 90 minutes and 180 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Adverse Events	3 hours and 7 Days	Included: Psychoactive effects, mood changes, and report other side effects after single dose of Epidiolex

Trial Locations

Locations (1)

The University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States