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 Utah
Indication
Chronic Pain