CBD for Dental Pain

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cannabidiol (CBD) for the Management of Emergency Dental Pain

Conditions
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Odontalgia, Toothache

Intervention / Treatment
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* Drug: Epidiolex 100 mg/mL Oral Solution
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidiolex 10mg/kg single dose<br>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. | Drug: Epidiolex 100 mg/mL Oral Solution<br>* 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<br>* Other names: Cannabidiol (CBD);|
| Experimental: Epidiolex 20mg/kg single dose<br>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. | Drug: Epidiolex 100 mg/mL Oral Solution<br>* 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<br>* Other names: Cannabidiol (CBD);|
| Placebo Comparator: Placebo group<br>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. | Drug: Placebo<br>* Placebo drug will be a solution with the same taste, texture and color as the drug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter- and intra-group VAS pain intensity changes from baseline at each time point and maximum pain relief | Patients will report their pain level using a 100mm Visual Analogue Scale at baseline, 15', 30',45',60',90', 120' 180' and 7 days after oral ingestion in our CRU | 3 Hours and 7 Days | 
| Bite Force Measurement | Patients will report their pain level that is elicited by biting down on the Bite Fork at various times to measure change in value. | Baseline to 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of adverse events | Included: Psychoactive effects, mood changes, and report other side effects after single doe of Epidiolex | 3 hours and 7 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cannabidiol (CBD), Opioid, Dose, Dental, Pain, Epidiolex, CBD