Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

NCT04271917 | Completed Phase 3 DMC FDA Drug

• 1 other identifier: 20-07123-XP
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Acute

Keywords

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

Outcome Measures

Primary Outcomes (3)

• Worst pain following surgery using Wong Baker Faces pain scale

  Self-report of participant's worst pain after surgery

  1-week post-op

• Amount of medication used

  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

  Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.

  First 72 hours post-op

Study Arms (4)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

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

Placebo

PLACEBO COMPARATOR

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

CBD 17mg/mL

EXPERIMENTAL

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

CBD 37 mg/mL

EXPERIMENTAL

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

Interventions

cannabidiol DRUG

Use of cannabidiol as an alternative to standard of care treatment of acute pain.

Also known as: CBD oil

CBD 17mg/mL; CBD 37 mg/mL

placebo DRUG

Inactive placebo oil to imitate CBD oil

Placebo

acetaminophen 500mg and ibuprofen 200mg combo DRUG

standard of care

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Tennessee: lead

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Cannabidiol; Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Karen J Derefinko, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

• Ammaar H Abidi, DDS, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 12, 2020
• First Posted: February 17, 2020
• Study Start: February 24, 2020
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: May 2, 2022

Record last verified: 2022-04

Locations

US (1)