Chronic PainEarly Phase 1NCT04044729

Mechanisms of CBD for Chronic Pain

A Early Phase 1 study testing Cannabidiol in people with Chronic Pain, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Chronic Pain
What is being tested?: Cannabidiol
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2020to 1 Dec 2024
Phase: Early Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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.

Who cannot join

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.

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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 locations and contacts

1 site in 1 country.

United States1 site

University Of Utah
Salt Lake City, Utah, 84108

Other trials in United States

About this study

Official title: Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy

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

Read the detailed 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.

Conditions: Chronic Pain
Being tested: Cannabidiol, Placebo
Medical subject headings: Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04044729
Study group	Role	What they receive
Cannabidiol	Active comparator	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 Receives: Drug: Cannabidiol
Placebo	Placebo comparator	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 Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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 the anterior cingulate cortex (ACC).
Proton magnetic resonance spectroscopy (1H-MRS) was used to quantify levels of glutamate and GABA, with a voxel localized to the anterior cingulate cortex. Because MRI scanner properties can vary across sessions, absolute signal intensities cannot always be converted into absolute concentrations. Instead, we report metabolite concentrations in institutional units, which are normalized, relative signal intensities that make data usable and comparable across MRI sessions. We report changes in metabolite concentrations from Visit 1 to Visit 5, where positive values indicate an increase in metabolite concentrations from Day 1 to Day 5, and negative values indicate a decrease in metabolite concentrations from Day 1 to Day 5.
Measured: 5 Days

Secondary outcomes (1)

Pain Improvement
Baseline pain assessment measures collected at Visit 1 and again at Visit 5 will be used to determine whether the administration of CBD or placebo will improve pain relief in individuals with chronic pain. We will measure pain intensity with a visual analog scale from (0-10) with 10 being the worst pain imaginable. We will measure pain unpleasantness with a visual analog scale from (0-10) with 10 being the most unpleasant pain imaginable. We report changes in pain intensity and pain unpleasantness from Visit 1 to Visit 5, where positive values indicate an increase in pain from Day 1 to Day 5, and negative values indicate a decrease in pain from Day 1 to Day 5.
Measured: 5 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20201 Dec 2024

First posted5 Aug 2019
Study start16 Mar 2020
Primary completion1 Dec 2024
Study completion1 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic PainStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04044729
Sponsor's protocol ID: IRB_00124865
Status last verified: Oct 2026
First submitted: 1 Aug 2019
Last updated: 29 Oct 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: The investigators are still deciding on if and what IPD will be shared and the details involved. The investigators will update when a plan is in place.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Exploring the Mechanisms Underlying the Analgesic Properties of Cannabidiol Using Magnetic Resonance Spectroscopy
ClinicalTrials.gov ID: NCT04044729
Acronym / sponsor ID: IRB_00124865
Conditions: Chronic Pain
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Study start: 16 Mar 2020 (actual)
Primary completion: 1 Dec 2024 (actual)
Study completion: 1 Dec 2024 (actual)
First posted: 5 Aug 2019 (actual)
Results: Posted 29 Oct 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Cannabidiol	Active comparator	Drug: CannabidiolDrug: 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 comparator	Drug: PlaceboDrug: 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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (12 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cannabidiol500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding	Drug	Cannabidiol
PlaceboPlacebo	Drug	Placebo

Primary outcome

Neurochemical Brain Changes
Time frame: 5 Days
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 the anterior cingulate cortex (ACC). Proton magnetic resonance spectroscopy (1H-MRS) was used to quantify levels of glutamate and GABA, with a voxel localized to the anterior cingulate cortex. Because MRI scanner properties can vary across sessions, absolute signal intensities cannot always be converted into absolute concentrations. Instead, we report metabolite concentrations in institutional units, which are normalized, relative signal intensities that make data usable and comparable across MRI sessions. We report changes in metabolite concentrations from Visit 1 to Visit 5, where positive values indicate an increase in metabolite concentrations from Day 1 to Day 5, and negative values indicate a decrease in metabolite concentrations from Day 1 to Day 5.

1 secondary outcome

Pain Improvement
Time frame: 5 Days

Results and safety

Results posted to the registry on 29 Oct 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cannabidiol	4	3
Placebo	7	6

Primary outcome: Neurochemical Brain Changes

Time frame: 5 Days. Mean (Standard Deviation). Unit: Institutional Unit (IU)

Measure	Cannabidiol n = 3	Placebo n = 5
Change in ACC Glutamate	0.28 (0.41)	1.01 (0.89)
Change in ACC GABA	0.22 (0.60)	0.13 (0.65)
Change in ACC Glutamate/GABA	-0.32 (0.82)	0.21 (0.94)

Population analysed: Of the four participants assigned to the Cannabidiol group, one did not complete the dosing visits, leaving three for analysis. Of the seven participants in the placebo group, one did not complete the dosing visits and one was excluded due to motion artifacts, leaving five for analysis.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data were collected each day during the dosing week and then at a follow-up visit scheduled within a week of the last dose, an average of 4.2 days.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cannabidiol	0 of 4 (0%)	3 of 4 (75%)	0 of 4
Placebo	0 of 7 (0%)	4 of 7 (57.1%)	0 of 7

Limitations and caveats (from the sponsor): Recruitment and enrollment were significantly impacted by the COVID-19 pandemic. The resurgence of COVID-19 in 2021 also detrimentally impacted our recruitment and in-person scheduled visits. In addition to COVID-related challenges, there were changes in key staffing, which required extensive training.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided. The investigators are still deciding on if and what IPD will be shared and the details involved. The investigators will update when a plan is in place.

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Recruiting
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RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
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Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
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Not yet recruiting
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Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Cannabidiol in people with Chronic Pain, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Neurochemical Brain Changes (time frame: 5 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04044729.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.