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

• ClinicalTrials.gov Identifier: NCT04271917
• Recruitment Status: Completed
• First Posted: February 17, 2020
• Last Update Posted: May 2, 2022
• Sponsor: University of Tennessee
• Information provided by (Responsible Party): Karen Derefinko, PhD, University of Tennessee Health Science Center

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Pain, Acute	Drug: cannabidiol; Drug: placebo; Drug: acetaminophen 500mg and ibuprofen 200mg combo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 68 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Since TAU participants will receive tablets instead of oil like the other 3 arms, the design is not completely double-blinded; however, the study will be double-blinded between the other three arms which all receive oil in a dropper vial.
• Primary Purpose: Treatment
• Official Title: Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
• Actual Study Start Date: February 24, 2020
• Actual Primary Completion Date: March 31, 2022
• Actual Study Completion Date: March 31, 2022

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Treatment As Usual (TAU); 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.	Drug: acetaminophen 500mg and ibuprofen 200mg combo; standard of care
Placebo Comparator: Placebo; 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.	Drug: placebo; Inactive placebo oil to imitate CBD oil
Experimental: CBD 17mg/mL; 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.	Drug: cannabidiol; Use of cannabidiol as an alternative to standard of care treatment of acute pain.; Other Name: CBD oil
Experimental: CBD 37 mg/mL; 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.	Drug: cannabidiol; Use of cannabidiol as an alternative to standard of care treatment of acute pain.; Other Name: CBD oil

Outcome Measures

Primary Outcome Measures :

1. Worst pain following surgery using Wong Baker Faces pain scale [ Time Frame: 1-week post-op ]
   Self-report of participant's worst pain after surgery
2. Amount of medication used [ Time Frame: 1-week post-op ]
   Self-report of total amount of pain medication used from participant diary
3. Pain levels following surgery using Wong Baker Faces pain scale [ Time Frame: First 72 hours post-op ]
   Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Tennessee

University of Tennessee Health Science Center

Memphis, Tennessee, United States, 38163

Sponsors and Collaborators

University of Tennessee

Investigators

• Principal Investigator: Karen J Derefinko, PhD; University of Tennessee
• Principal Investigator: Ammaar H Abidi, DDS, PhD; University of Tennessee

More Information

• Responsible Party: Karen Derefinko, PhD, Assistant Professor, University of Tennessee Health Science Center
• ClinicalTrials.gov Identifier: NCT04271917
• Other Study ID Numbers: 20-07123-XP
• First Posted: February 17, 2020
• Last Update Posted: May 2, 2022
• Last Verified: April 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Karen Derefinko, PhD, University of Tennessee Health Science Center:

cannabidiol; CBD; acute pain; alternative pain management; simple extraction

Additional relevant MeSH terms:

Cannabidiol; Acute Pain; Pain; Neurologic Manifestations; Acetaminophen; Ibuprofen; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Antipyretics; Anti-Inflammatory Agents, Non-Steroidal; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Anticonvulsants