Mechanisms of CBD for Chronic Pain
|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: NCT04044729|
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pain||Drug: Cannabidiol Drug: Placebo||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||52 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy|
|Estimated Study Start Date :||January 1, 2020|
|Estimated Primary Completion Date :||December 30, 2020|
|Estimated Study Completion Date :||December 30, 2021|
Active Comparator: Cannabidiol
Drug: 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.
500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding
Placebo Comparator: Placebo
Drug: Placebos An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
- Neurochemical Brain Changes [ Time Frame: 5 Days ]Participants will undergo MRS scanning to assess neurochemical shifts from the baseline visit (day 1) to the visit five (day 5) in order to determine whether CBD, or Placebo will result in changes to neurochemical ratios in select brain regions. Neurotransmitter levels such as BABA and N-Acetylaspartate will be collected and compared pre and post study drug administration.
- Pain Improvement [ 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 whether the administration of CBD or placebo will improve pain relief in individuals with chronic pain. We will measure pain intensity with a visual analog scale from (0-10) with 10 being the worst pain imaginable. We will also measure Objective pain thresholds with a pressure algometer. This is a device that applies pressure to the participants finger until they say stop. The pressure range is 0-50 foot pounds of force.
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): NCT04044729
|Contact: Matt Hodgkinson, B.S.,RNfirstname.lastname@example.org|
|Contact: Deborah Yurgelun-Todd, PhD|