Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients

NCT ID: NCT04271917

Last Updated: 2022-05-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-24

Study Completion Date

2022-03-31

Brief Summary

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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

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Conditions

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Pain, Acute

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

acetaminophen 500mg and ibuprofen 200mg combo

Intervention Type DRUG

standard of care

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.

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Inactive placebo oil to imitate CBD oil

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.

Group Type EXPERIMENTAL

cannabidiol

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

cannabidiol

Intervention Type DRUG

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

Interventions

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cannabidiol

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

Intervention Type DRUG

placebo

Inactive placebo oil to imitate CBD oil

Intervention Type DRUG

acetaminophen 500mg and ibuprofen 200mg combo

standard of care

Intervention Type DRUG

Other Intervention Names

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CBD oil

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Karen Derefinko, PhD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen J Derefinko, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Ammaar H Abidi, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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University of Tennessee Health Science Center

Memphis, Tennessee, United States

Site Status

Countries

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United States

Other Identifiers

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20-07123-XP

Identifier Type: -

Identifier Source: org_study_id

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