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

Primary Purpose

Pain, Acute

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
cannabidiol
placebo
acetaminophen 500mg and ibuprofen 200mg combo
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Acute focused on measuring cannabidiol, CBD, acute pain, alternative pain management, simple extraction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Experimental

Experimental

Arm Label

Treatment As Usual (TAU)

Placebo

CBD 17mg/mL

CBD 37 mg/mL

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Worst pain following surgery using Wong Baker Faces pain scale
Self-report of participant's worst pain after surgery
Amount of medication used
Self-report of total amount of pain medication used from participant diary
Pain levels following surgery using Wong Baker Faces pain scale
Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.

Secondary Outcome Measures

Full Information

First Posted
February 12, 2020
Last Updated
April 29, 2022
Sponsor
University of Tennessee
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1. Study Identification

Unique Protocol Identification Number
NCT04271917
Brief Title
Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
Acronym
SWAP
Official Title
Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 24, 2020 (Actual)
Primary Completion Date
March 31, 2022 (Actual)
Study Completion Date
March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Acute
Keywords
cannabidiol, CBD, acute pain, alternative pain management, simple extraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual (TAU)
Arm Type
Active Comparator
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
CBD 17mg/mL
Arm Type
Experimental
Arm 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.
Arm Title
CBD 37 mg/mL
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
cannabidiol
Other Intervention Name(s)
CBD oil
Intervention Description
Use of cannabidiol as an alternative to standard of care treatment of acute pain.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Inactive placebo oil to imitate CBD oil
Intervention Type
Drug
Intervention Name(s)
acetaminophen 500mg and ibuprofen 200mg combo
Intervention Description
standard of care
Primary Outcome Measure Information:
Title
Worst pain following surgery using Wong Baker Faces pain scale
Description
Self-report of participant's worst pain after surgery
Time Frame
1-week post-op
Title
Amount of medication used
Description
Self-report of total amount of pain medication used from participant diary
Time Frame
1-week post-op
Title
Pain levels following surgery using Wong Baker Faces pain scale
Description
Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.
Time Frame
First 72 hours post-op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J Derefinko, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ammaar H Abidi, DDS, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

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