Chronic Pain Clinical Trial
Official title:
Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.
Status | Recruiting |
Enrollment | 52 |
Est. completion date | February 28, 2025 |
Est. primary completion date | December 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | Inclusion Criteria: - Age between 18-50 yrs. - 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. Exclusion Criteria: - Current or past neurological illness. - Substance abuse or dependence within the prior 90 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 at PI discretion. - Active or history of major mental illness - Use of opioid medications in the past 30 days. - LFT results 3 times greater than the upper limit of normal at the screening. - Participants may be excluded if the PI feels they do not meet safety criteria. |
Country | Name | City | State |
---|---|---|---|
United States | University Of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Neurochemical Brain Changes | 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. | 5 Days | |
Secondary | Pain Improvement | 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. | 7 Days |
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