Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)
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|ClinicalTrials.gov Identifier: NCT03215940|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : March 10, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain, Widespread||Drug: Delta-9-Tetrahydrocannabinol Drug: Cannabidiol Drug: Placebos||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||December 30, 2022|
|Estimated Study Completion Date :||March 2023|
Active Comparator: 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.
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.
Active Comparator: 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.
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.
Other Name: CBD
Placebo Comparator: 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.
An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
Other Name: placebo
- Brain Changes [ Time Frame: 5 days ]Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at the baseline visit (day 1) and visit five (day 5) in order to determine whether the administration of Delta-9-THC, CBD, or Placebo will result in changes to these brain indices in participants with chronic pain.
- Improvement in pain relief [ Time Frame: 7 days ]Using baseline assessment measures gathered at visit 0 (Screening), assessments collected at visits 1-5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will improve pain relief in individuals with chronic pain.
- Neurocognitive performance [ Time Frame: 3 days ]Using baseline assessment measures gathered at visit 1, assessments collected at visits 5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will adversely effect neurocognitive performance in individuals with chronic pain.
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|Ages Eligible for Study:||18 Years to 50 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- Age between 18-50 yrs.
- History of cannabis use.
- Chronic musculoskeletal and joint pain for at least 3 months or longer.
- Participants must live within a 60 mile radius of Salt Lake City, Utah to be eligible.
- Current or past neurological illness.
- Substance abuse or dependence within the prior 60 days.
- Contraindication to brain MRI.
- Type I and type II diabetes.
- Unstable medical conditions.
- Consumption of more than 2 drinks of alcohol per night.
- Current pregnancy or planning to become pregnant or breastfeeding
- History of seizures or head trauma
- Active or history of major mental illness
- LFT results 3 times greater than the upper limit of normal at screening.
- Participants may be excluded if the PI feels they do not meet safety criteria.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03215940
|Contact: Matt Hodgkinson, B.S.,RNfirstname.lastname@example.org|
|United States, Utah|
|University Of Utah||Recruiting|
|Salt Lake City, Utah, United States, 84108|
|Principal Investigator:||Deborah Yurgelun-Todd, Ph.D.||University of Utah Brain Institute|
|Responsible Party:||Deborah Yurgelun-Todd, Director of the Brain Institute, University of Utah|
|Other Study ID Numbers:||
|First Posted:||July 12, 2017 Key Record Dates|
|Last Update Posted:||March 10, 2022|
|Last Verified:||March 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan Description:||The investigators are still deciding on if and what IPD will be shared and the details involved. The investigators will update when a plan is in place.|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Cannabinoid Receptor Agonists
Cannabinoid Receptor Modulators
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists