OdontalgiaPhase 1/2NCT04642404
CBD for Dental Pain
A Phase 1/2 study testing Epidiolex 100 mg/mL Oral Solution in people with Odontalgia and Toothache, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Odontalgia, Toothache
- What is being tested?
- Epidiolex 100 mg/mL Oral Solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2021to 13 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: Cannabidiol (CBD) for the Management of Emergency Dental Pain
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.
Read the 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.
- Conditions
- Odontalgia, Toothache
- Being tested
- Epidiolex 100 mg/mL Oral Solution, Placebo
- Keywords
- Cannabidiol (CBD), Opioid, Dose, Dental, Pain, Epidiolex, CBD
- Medical subject headings
- Toothache, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidiolex 100 mg/mL Oral SolutionDrug
Also called Cannabidiol (CBD)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 90 minutes and 180 minutes
Secondary outcomes (1)
Number of Participants With Adverse Events
Included: Psychoactive effects, mood changes, and report other side effects after single dose of Epidiolex
Measured: 3 hours and 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start1 Mar 2021
- Primary completion2 Mar 2023
- Study completion13 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OdontalgiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center at San Antonio
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vanessa Chrepa, DDS MS, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642404
- Sponsor's protocol ID
- HSC20200305H
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2020
- Last updated
- 9 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol (CBD) for the Management of Emergency Dental Pain
- ClinicalTrials.gov ID
- NCT04642404
- Acronym / sponsor ID
- HSC20200305H
- Conditions
- Odontalgia, Toothache
- Keywords
- Cannabidiol (CBD), Opioid, Dose, Dental, Pain, Epidiolex, CBD
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 2 Mar 2023 (actual)
- Study completion
- 13 Mar 2023 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Posted 17 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidiolex 10mg/kg single dose | Experimental | Drug: Epidiolex 100 mg/mL Oral SolutionAfter 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 | Experimental | Drug: Epidiolex 100 mg/mL Oral SolutionThe 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 comparator | Drug: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidiolex 100 mg/mL Oral SolutionAlso: Cannabidiol (CBD)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 | Drug | Epidiolex 10mg/kg single dose, Epidiolex 20mg/kg single dose |
| PlaceboPlacebo drug will be a solution with the same taste, texture and color as the drug. | Drug | Placebo group |
Primary outcome
Intra-group VAS Pain Intensity and Maximum Pain Relief
Time frame: 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
Time frame: 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.
1 secondary outcome
Number of Participants With Adverse Events
Time frame: 3 hours and 7 Days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Chrepa, DDS MS principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epidiolex 100 mg/mL Oral Solution in people with Odontalgia and Toothache, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intra-group VAS Pain Intensity and Maximum Pain Relief (time frame: Baseline to 180 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.