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

Sponsor

University of Tennessee (Other)

Overall Status

Completed

CT.gov ID

NCT04271917

Collaborator

(none)

Enrollment

Location

Arms

25.2

Actual Duration (Months)

2.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Pain, Acute	Drug: cannabidiol Drug: placebo Drug: acetaminophen 500mg and ibuprofen 200mg combo	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

68 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 :

Feb 24, 2020

Actual Primary Completion Date :

Mar 31, 2022

Actual Study Completion Date :

Mar 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Worst pain following surgery using Wong Baker Faces pain scale [1-week post-op]
Self-report of participant's worst pain after surgery
Amount of medication used [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 [First 72 hours post-op]
Self-reported pain recorded every 2 hours between 7am-9pm by automated SMS messaging.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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