Mechanisms of CBD for Chronic Pain

Utah System of Higher Education (USHE)

Status and phase: Completed; Early Phase 1

Conditions: Chronic Pain

Treatments: Drug: Cannabidiol; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04044729

IRB_00124865

Details and patient eligibility

About

This is a study designed to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain.

Full description

The aim of this trial is to examine the neurochemical mechanisms associated with Cannabidiol (CBD) versus placebo for chronic non-cancer pain. Participants will include individuals with chronic pain, who will be randomized into one of two intervention conditions: low THC/high CBD or placebo. In addition to receiving CBD or placebo, participants also will complete symptom assessments of chronic pain data (intensity, quality, interference/disability) throughout the study. These measures will be gathered prior to and following the fifth doses (dosing will occur once per day for five days) of CBD or placebo. A secondary objective will be to examine the association between clinical and inflammatory markers.

Enrollment: 24 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Cannabidiol

Active Comparator group

Description:

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. Other Names: CBD

Treatment:

Drug: Cannabidiol

Placebo

Placebo Comparator group

Description:

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. Other Names: placebo

Treatment:

Drug: Placebo