Cannabinoid
Epidiolex 100 mg/mL Oral Solution for Toothache
The University of Texas Health Science Center at San Antonio, San Antonio, TX
Epidiolex 100 mg/mL Oral Solution +1 morePhase 1 & 2Waitlist AvailableLed by Vanessa Chrepa, DDS MSResearch Sponsored by The University of Texas Health Science Center at San AntonioEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Permanent tooth with moderate to severe odontogenic pain, i.e. ≥30 on a 100mm VAS,
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up3 hours and 7 days
Awards & highlights
Approved for 10 Other Conditions
All Individual Drugs Already Approved
Study Summary
This trial will test whether CBD can help relieve dental pain. Subjects will be given either CBD or a placebo, and then monitored for pain and psychological effects for 3 hours.
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a toothache with moderate to severe pain, rated as 30 or higher on a 100-point scale.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 hours and 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 hours and 7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Bite Force Measurement
Inter- and intra-group VAS pain intensity changes from baseline at each time point and maximum pain relief
Secondary outcome measures
Measure of adverse events
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Epidiolex 20mg/kg single doseExperimental Treatment1 Intervention
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.
Group II: Epidiolex 10mg/kg single doseExperimental Treatment1 Intervention
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.
Group III: Placebo groupPlacebo Group1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
FDA approved
Find a site
Who is running the clinical trial?
The University of Texas Health Science Center at San AntonioLead Sponsor
431 Previous Clinical Trials
83,180 Total Patients Enrolled
Vanessa Chrepa, DDS MSPrincipal Investigator - University of Texas Health Science Center San Antonio
The University of Texas Health Science Center at San Antonio
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this medical experiment actively engaging those over seventy years of age?
"As outlined in the guidelines for this trial, only individuals aged between 18 and 75 are qualified to participate."
Answered by AI
Might I qualify to be a participant in this experiment?
"In order to be accepted, potential volunteers must suffer from dental pain and fit within the 18-75 year old age bracket. The research team is looking for a total of 60 participants."
Answered by AI
Is this research initiative still open to new participants?
"As per clinicaltrials.gov, this experiment is still accepting applicants. Initially announced on March 1st 2021 and edited lastly on March 31st 2022, the trial requires more participants to join in its endeavour."
Answered by AI
What have been the findings of prior research into Epidiolex 100 mg/mL Oral Solution?
"Currently, 79 clinical trials for Epidiolex 100 mg/mL Oral Solution are occurring worldwide. Out of these trials, 16 have progressed to Phase 3 already. The majority of studies are based in Ribeirao Preto, Sao Paulo with a total number of 290 sites participating overall."
Answered by AI
How many participants are enrolled in this research endeavor?
"Affirmative. Clinicaltrials.gov show that this trial is accepting applicants and was first published on March 1st 2021, with the most recent ammendments occuring at the end of March 2022. The project requires 60 volunteers from a single hospital site."
Answered by AI