Phase 2
N=64
CBD for Dental Pain
Odontalgia · Toothache
Bottom Line
View on ClinicalTrials.gov: NCT04642404 ↗Enrolled (actual)
64
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Intra-group VAS Pain Intensity and Maximum Pain Relief — 63; 69; 63; 21 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Epidiolex 100 mg/mL Oral Solution (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The University of Texas Health Science Center at San Antonio
- Primary completion
- Mar 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Intra-group VAS Pain Intensity and Maximum Pain Relief |
63; 69; 63; 21; 20; 48 | — |
| PRIMARY Bite Force Measurement |
61; 53; 54; 86; 59; 66 | — |
| SECONDARY Number of Participants With Adverse Events |
9; 6; 1; 2; 0; 2 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT04642404). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.