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

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ClinicalTrials.gov Identifier: NCT04271917
Recruitment Status : Suspended (COVID-19)
First Posted : February 17, 2020
Last Update Posted : September 28, 2021
Sponsor:
Information provided by (Responsible Party):
Karen Derefinko, PhD, University of Tennessee Health Science Center

Tracking Information
First Submitted Date  ICMJE February 12, 2020
First Posted Date  ICMJE February 17, 2020
Last Update Posted Date September 28, 2021
Actual Study Start Date  ICMJE February 24, 2020
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • 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
  • Amount of medication used [ Time Frame: 1-week post-op ]
    Self-report of total amount of pain medication used from participant diary
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
Official Title  ICMJE Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE 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
Condition  ICMJE Pain, Acute
Intervention  ICMJE
  • Drug: cannabidiol
    Use of cannabidiol as an alternative to standard of care treatment of acute pain.
    Other Name: CBD oil
  • Drug: placebo
    Inactive placebo oil to imitate CBD oil
  • Drug: acetaminophen 500mg and ibuprofen 200mg combo
    standard of care
Study Arms  ICMJE
  • 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.

    Intervention: Drug: acetaminophen 500mg and ibuprofen 200mg combo
  • 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.

    Intervention: Drug: placebo
  • 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.

    Intervention: Drug: cannabidiol
  • 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.

    Intervention: Drug: cannabidiol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: February 14, 2020)
120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2022
Estimated Primary Completion Date June 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04271917
Other Study ID Numbers  ICMJE 20-07123-XP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Karen Derefinko, PhD, University of Tennessee Health Science Center
Study Sponsor  ICMJE University of Tennessee
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Karen J Derefinko, PhD University of Tennessee
Principal Investigator: Ammaar H Abidi, DDS, PhD University of Tennessee
PRS Account University of Tennessee
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP