Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03215940|
Recruitment Status : Recruiting
First Posted : July 12, 2017
Last Update Posted : January 28, 2021
|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, 2021|
|Estimated Study Completion Date :||March 2022|
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.
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.,RNemail@example.com|
|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|