Mechanisms of CBD for Chronic Pain
Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
1 other identifier
interventional
24
1 country
1
Brief Summary
This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1 chronic-pain
Started Mar 2020
Longer than P75 for early_phase_1 chronic-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
March 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedApril 13, 2025
April 1, 2025
4.7 years
August 1, 2019
April 9, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Pain Improvement
7 Days
Study Arms (2)
Cannabidiol
ACTIVE COMPARATORDrug: 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. Other Names: CBD
Placebo
PLACEBO COMPARATORDrug: Placebos An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day. Other Names: placebo
Interventions
500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Of Utah
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 5, 2019
Study Start
March 16, 2020
Primary Completion
December 1, 2024
Study Completion
December 1, 2024
Last Updated
April 13, 2025
Record last verified: 2025-04