Clinical trial
Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
Name
IRB_00124865
Description
This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.
Trial arms
Trial start
2020-03-16
Estimated PCD
2024-12-30
Trial end
2025-02-28
Status
Recruiting
Phase
Early phase I
Treatment
Cannabidiol
500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding
Arms:
Cannabidiol
Placebo
Placebo
Arms:
Placebo
Size
52
Primary endpoint
Neurochemical Brain Changes
5 Days
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 52, 'type': 'ESTIMATED'}}
Updated at
2024-04-26
1 organization
1 product
1 indication
Organization
University of UtahProduct
CannabidiolIndication
Chronic Pain