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Cannabinoid

Epidiolex 100 mg/mL Oral Solution for Toothache

Phase 1 & 2

Waitlist Available

Led By Vanessa Chrepa, DDS MS

Research Sponsored by The University of Texas Health Science Center at San Antonio

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 hours and 7 days

Awards & highlights

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 hours and 7 days for reporting.

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

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

Epidiolex 100 mg/mL Oral Solution

2021

Completed Phase 2

~70

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

The University of Texas Health Science Center at San AntonioLead Sponsor

452 Previous Clinical Trials

91,350 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

Recent research and studies

clinicaltrials.govStudy

CBD for Dental Pain

Vanessa Chrepa 2021. "CBD for Dental Pain". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04642404.