CBD for Dental Pain

NCT04642404 | Completed Phase 1 Results FDA Drug

• 1 other identifier: HSC20200305H
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Odontalgia; Toothache

Keywords

Cannabidiol (CBD); Opioid; Dose; Dental; Pain; Epidiolex; CBD

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, 90 minutes and 180 minutes

Secondary Outcomes (1)

• Number of Participants With Adverse Events

  3 hours and 7 Days

Study Arms (3)

Epidiolex 10mg/kg single dose

EXPERIMENTAL

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

Epidiolex 20mg/kg single dose

EXPERIMENTAL

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

Placebo group

PLACEBO COMPARATOR

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

Interventions

Epidiolex 100 mg/mL Oral Solution DRUG

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

Also known as: Cannabidiol (CBD)

Epidiolex 10mg/kg single dose; Epidiolex 20mg/kg single dose

Placebo DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Toothache; Pain

Interventions

Cannabidiol; Solutions

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Pharmaceutical Preparations

Results Point of Contact

• Title: Vanessa Chrepa, DDS
• Organization: University of Texas Health Science Center at San Antonio

vanessa.chrepa@rutgers.edu

210-459-3601

Study Officials

• Vanessa Chrepa, DDS MS

  University of Texas Health Science Center San Antonio

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients who satisfy eligibility criteria and provide written informed consent will be randomly assigned to either 1) CBD 10mg/kg single dose (drug: Epidiolex 100mg/ml solution) or 2) CBD 20mg/kg single dose, or 3) Placebo group (drug: placebo)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: November 24, 2020
• Study Start: March 1, 2021
• Primary Completion: March 2, 2023
• Study Completion: March 13, 2023
• Last Updated: May 9, 2024
• Results First Posted: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)