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

April 29, 2022 updated by: Karen Derefinko, PhD, University of Tennessee

Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38163
        • University of Tennessee Health Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • CBD oil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1-week post-op
Amount of medication used
Time Frame: 1-week post-op
Self-report of total amount of pain medication used from participant diary
1-week post-op
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.
First 72 hours post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Tennessee

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2020

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

February 12, 2020

First Submitted That Met QC Criteria

February 14, 2020

First Posted (Actual)

February 17, 2020

Study Record Updates

Last Update Posted (Actual)

May 2, 2022

Last Update Submitted That Met QC Criteria

April 29, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-07123-XP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe