Pain, AcutePhase 3SWAPNCT04271917
Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
A Phase 3 study testing cannabidiol and acetaminophen 500mg and ibuprofen 200mg combo in people with Pain, Acute, run by University of Tennessee at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Acute
- What is being tested?
- cannabidiol and acetaminophen 500mg and ibuprofen 200mg combo
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Feb 2020to 31 Mar 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
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
- Being tested
- cannabidiol, placebo, acetaminophen 500mg and ibuprofen 200mg combo
- Keywords
- cannabidiol, CBD, acute pain, alternative pain management, simple extraction
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cannabidiolDrug
Also called CBD oil
Use of cannabidiol as an alternative to standard of care treatment of acute pain.
placeboDrug
Inactive placebo oil to imitate CBD oil
acetaminophen 500mg and ibuprofen 200mg comboDrug
standard of care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: cannabidiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Worst pain following surgery using Wong Baker Faces pain scale
Self-report of participant's worst pain after surgery
Measured: 1-week post-op
Amount of medication used
Self-report of total amount of pain medication used from participant diary
Measured: 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.
Measured: First 72 hours post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2020
- Study start24 Feb 2020
- Primary completion31 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tennessee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Derefinko, PhD, University of Tennessee
- Investigators
- Karen J Derefinko, PhD, Principal investigator, University of TennesseeAmmaar H Abidi, DDS, PhD, Principal investigator, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04271917
- Sponsor's protocol ID
- 20-07123-XP
- Acronym
- SWAP
- Status last verified
- Apr 2022
- First submitted
- 12 Feb 2020
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgery With Alternative Pain Management (SWAP): Analgesic Effects of Cannabidiol for Simple Tooth Extractions in Dental Patients
- ClinicalTrials.gov ID
- NCT04271917
- Acronym / sponsor ID
- SWAP / 20-07123-XP
- Conditions
- Pain, Acute
- Keywords
- cannabidiol, CBD, acute pain, alternative pain management, simple extraction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- University of TennesseeUniversity, hospital or other
- Study start
- 24 Feb 2020 (actual)
- Primary completion
- 31 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 17 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | Active comparator | Drug: acetaminophen 500mg and ibuprofen 200mg comboParticipants 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. |
| Placebo | Placebo comparator | Drug: placeboParticipants 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. |
| CBD 17mg/mL | Experimental | Drug: cannabidiolParticipants 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. |
| CBD 37 mg/mL | Experimental | Drug: cannabidiolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindication to ibuprofen
- Contraindication to acetaminophen
- Contraindication to cannabidiol or hemp oil
- Contraindication to peppermint oil
- Contraindication to almond or other tree nuts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cannabidiolAlso: CBD oilUse of cannabidiol as an alternative to standard of care treatment of acute pain. | Drug | CBD 17mg/mL, CBD 37 mg/mL |
| placeboInactive placebo oil to imitate CBD oil | Drug | Placebo |
| acetaminophen 500mg and ibuprofen 200mg combostandard of care | Drug | Treatment As Usual (TAU) |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J Derefinko, PhD principal investigator
University of Tennessee
Ammaar H Abidi, DDS, PhD principal investigator
University of Tennessee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cannabidiol and acetaminophen 500mg and ibuprofen 200mg combo in people with Pain, Acute, run by University of Tennessee at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Worst pain following surgery using Wong Baker Faces pain scale (time frame: 1-week post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.