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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04271917
Recruitment Status : Suspended (COVID-19)
First Posted : February 17, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Karen Derefinko, PhD, University of Tennessee Health Science Center

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 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
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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




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.



Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04271917


Locations
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United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
University of Tennessee
Investigators
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Principal Investigator: Karen J Derefinko, PhD University of Tennessee
Principal Investigator: Ammaar H Abidi, DDS, PhD University of Tennessee
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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    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Epidiolex
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