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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cannabidiol | Drug | Use of cannabidiol as an alternative to standard of care treatment of acute pain. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen J Derefinko, PhD | University of Tennessee | Principal Investigator |
| Ammaar H Abidi, DDS, PhD | University of Tennessee | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
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| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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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.
| placebo | Drug | Inactive placebo oil to imitate CBD oil |
|
| acetaminophen 500mg and ibuprofen 200mg combo | Drug | standard of care |
|
| D000083 |
| Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |