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CBD for Dental Pain

Primary Purpose

Odontalgia, Toothache

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Epidiolex 100 mg/mL Oral Solution
Placebo
Sponsored by
The University of Texas Health Science Center at San Antonio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Odontalgia focused on measuring Cannabidiol (CBD), Opioid, Dose, Dental, Pain, Epidiolex, CBD

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The University of Texas Health Science Center at San Antonio

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Epidiolex 10mg/kg single dose

Epidiolex 20mg/kg single dose

Placebo group

Arm Description

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.

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 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.

Outcomes

Primary Outcome Measures

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
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.

Secondary Outcome Measures

Measure of adverse events
Included: Psychoactive effects, mood changes, and report other side effects after single doe of Epidiolex

Full Information

First Posted
November 19, 2020
Last Updated
March 25, 2023
Sponsor
The University of Texas Health Science Center at San Antonio
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1. Study Identification

Unique Protocol Identification Number
NCT04642404
Brief Title
CBD for Dental Pain
Official Title
Cannabidiol (CBD) for the Management of Emergency Dental Pain
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 2, 2023 (Actual)
Study Completion Date
March 13, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center at San Antonio

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Odontalgia, Toothache
Keywords
Cannabidiol (CBD), Opioid, Dose, Dental, Pain, Epidiolex, CBD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
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)
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epidiolex 10mg/kg single dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Epidiolex 20mg/kg single dose
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Epidiolex 100 mg/mL Oral Solution
Other Intervention Name(s)
Cannabidiol (CBD)
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo drug will be a solution with the same taste, texture and color as the drug.
Primary Outcome Measure Information:
Title
Inter- and intra-group VAS pain intensity changes from baseline at each time point and maximum pain relief
Description
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
Time Frame
3 Hours and 7 Days
Title
Bite Force Measurement
Description
Patients will report their pain level that is elicited by biting down on the Bite Fork at various times to measure change in value.
Time Frame
Baseline to 7 Days
Secondary Outcome Measure Information:
Title
Measure of adverse events
Description
Included: Psychoactive effects, mood changes, and report other side effects after single doe of Epidiolex
Time Frame
3 hours and 7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Chrepa, DDS MS
Organizational Affiliation
University of Texas Health Science Center San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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CBD for Dental Pain

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