CBD for Dental Pain

The University of Texas Health Science Center at San Antonio64 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Odontalgia Toothache

Interventions

Epidiolex 100 mg/mL Oral SolutionDRUG

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

PlaceboDRUG

Placebo drug will be a solution with the same taste, texture and color as the drug.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline to 180 minutes

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.

Time frame: Baseline, 90 minutes and 180 minutes

Secondary Outcomes

Number of Participants With Adverse Events

Included: Psychoactive effects, mood changes, and report other side effects after single dose of Epidiolex

Time frame: 3 hours and 7 Days

Data from ClinicalTrials.gov

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