Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients (SWAP)

University of Tennessee

Status and phase: Completed; Phase 3

Conditions: Pain, Acute

Treatments: Drug: cannabidiol; Drug: acetaminophen 500mg and ibuprofen 200mg combo; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04271917

20-07123-XP

Details and patient eligibility

About

The purpose of this study is to evaluate the analgesic effects of cannabidiol for patients who have undergone simple tooth extraction. Participants will be randomized to one of four arms: treatment-as-usual (TAU), cannabidiol 17mg/mL, cannabidiol 37mg/mL, or placebo.

Enrollment: 68 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presenting for an operatory appointment at University of Tennessee Health Science Center College of Dentistry Oral and Maxillofacial Surgery Department
• Operation must be a simple tooth extraction which does not result in an opioid prescription
• 18 years of age or older
• Have regular and direct access to a device that can send and receive texts and willing to accept any associated charges for 24 text messages

Exclusion criteria

• Contraindication to ibuprofen
• Contraindication to acetaminophen
• Contraindication to cannabidiol or hemp oil
• Contraindication to peppermint oil
• Contraindication to almond or other tree nuts
• Currently taking a form of cannabidiol and unwilling to stop use for one week post surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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68 participants in 4 patient groups, including a placebo group

Treatment As Usual (TAU)

Active Comparator group

Description:

Participants will receive a 5-day supply of acetaminophen 500mg and ibuprofen 200mg. Instructions for use: Take one tablet of each medication at the same time every 4-6 hours as needed for pain.

Treatment:

Drug: acetaminophen 500mg and ibuprofen 200mg combo

Placebo

Placebo Comparator group

Description:

Participants will receive a 5-day supply (15mL) of inactive placebo in a dropper vial. Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.

Treatment:

Drug: placebo

CBD 17mg/mL

Experimental group

Description:

Participants will receive a 5-day supply (15mL) of cannabidiol 17mg/mL. Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.

Treatment:

Drug: cannabidiol

CBD 37 mg/mL

Experimental group

Description:

Participants will receive a 5-day supply (15mL) of cannabidiol 37mg/mL. Instructions for use: Place 0.5mL of oil under tongue for 30 seconds then swallow. Use every 4-6 hours as needed for pain.

Treatment:

Drug: cannabidiol