Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)
NCT ID: NCT03215940
Last Updated: 2025-04-13
Study Results
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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COMPLETED
EARLY_PHASE1
53 participants
INTERVENTIONAL
2018-02-01
2024-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain
This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain.
Delta-9-Tetrahydrocannabinol
An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.
Cannabidiol's (CBD) effects on pain
This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain.
Cannabidiol
An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.
Placebo
This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain.
Placebos
An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
Interventions
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Delta-9-Tetrahydrocannabinol
An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.
Cannabidiol
An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.
Placebos
An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. History of cannabis use.
3. Chronic musculoskeletal and joint pain for at least 3 months or longer.
4. Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.
Exclusion Criteria
2. Substance abuse or dependence within the prior 60 days.
3. Contraindication to brain MRI.
4. Type I and type II diabetes.
5. Unstable medical conditions.
6. Consumption of more than 2 drinks of alcohol per night.
7. Current pregnancy or planning to become pregnant or breastfeeding
8. History of seizures or head trauma
9. Active or history of major mental illness
10. LFT results 3 times greater than the upper limit of normal at screening.
11. Participants may be excluded if the PI feels they do not meet safety criteria.
18 Years
50 Years
ALL
Yes
Sponsors
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University of Utah
OTHER
Responsible Party
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Deborah Yurgelun-Todd
Director of the Brain Institute
Principal Investigators
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Deborah Yurgelun-Todd, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Utah Brain Institute
Locations
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University Of Utah
Salt Lake City, Utah, United States
Countries
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Other Identifiers
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IRB_00103451
Identifier Type: -
Identifier Source: org_study_id
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