Mechanisms of CBD for Chronic Pain

NCT ID: NCT04044729

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2024-12-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cannabidiol

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

Group Type ACTIVE_COMPARATOR

Cannabidiol

Intervention Type DRUG

500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Cannabidiol

500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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Deborah Yurgelun-Todd

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Of Utah

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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IRB_00124865

Identifier Type: -

Identifier Source: org_study_id

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