Chronic Pain, WidespreadEarly Phase 1NCT03215940
Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC)
A Early Phase 1 study testing Delta-9-Tetrahydrocannabinol and Cannabidiol in people with Chronic Pain, Widespread, run by University of Utah at 1 site in United States.
Trial summary
This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Widespread
- What is being tested?
- Delta-9-Tetrahydrocannabinol and Cannabidiol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2018to 1 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18-50 yrs.
- History of cannabis use.
- 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 60 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
- Active or history of major mental illness
- LFT results 3 times greater than the upper limit of normal at screening.
- Participants may be excluded if the PI feels they do not meet safety criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes
This is a study comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.
Read the detailed description
The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/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/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.
- Conditions
- Chronic Pain, Widespread
- Being tested
- Delta-9-Tetrahydrocannabinol, Cannabidiol, Placebos
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delta-9-TetrahydrocannabinolDrug
Also called THC, Delta-9-THC
An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.
CannabidiolDrug
Also called CBD
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.
PlacebosDrug
Also called placebo
An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
| Study group | Role | What they receive |
|---|---|---|
| Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain | Active comparator | This arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain. Receives: Drug: Delta-9-Tetrahydrocannabinol |
| Cannabidiol's (CBD) effects on pain | Active comparator | This arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain. Receives: Drug: Cannabidiol |
| Placebo | Placebo comparator | This Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain Changes
Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at the baseline visit (day 1) and visit five (day 5) in order to determine whether the administration of Delta-9-THC, CBD, or Placebo will result in changes to these brain indices in participants with chronic pain.
Measured: 5 days
Secondary outcomes (1)
Improvement in pain relief
Using baseline assessment measures gathered at visit 0 (Screening), assessments collected at visits 1-5 and follow-up will be used to determine wether the administration of Delta-9-THC, CBD, or placebo will improve pain relief in individuals with chronic pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Feb 2018
- 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.
- Other trials for Chronic Pain, WidespreadStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Yurgelun-Todd, University of Utah
- Investigators
- Deborah Yurgelun-Todd, Ph.D., Principal investigator, University of Utah Brain Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215940
- Sponsor's protocol ID
- IRB_00103451
- Status last verified
- Apr 2025
- First submitted
- 27 Jun 2017
- Last updated
- 13 Apr 2025
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Chronic Pain With Cannabidiol (CBD) and Delta-9-tetrahydrocannabinol (THC): Effectiveness, Side Effects and Neurobiological Changes
- ClinicalTrials.gov ID
- NCT03215940
- Acronym / sponsor ID
- IRB_00103451
- Conditions
- Chronic Pain, Widespread
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
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 comparing the effects of Delta-9-Tetrahydrocannabinol (THC) versus Cannabidiol (CBD) versus a placebo on chronic non-cancer pain.
Detailed description
The overall aim of this study is to examine the effects of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) on chronic pain symptoms, specifically we will examine the effects of different doses of THC/CBD on symptoms of chronic pain and life functioning. Participants will include individuals with chronic pain, who will be randomized into one of three intervention conditions: high THC/low CBD, low THC/high CBD, or placebo. In addition to receiving THC/CBD/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/THC or placebo. A secondary objective will be to examine the association between clinical and neurocognitive variables and use of CBD/THC, including the potential side effects of THC/CBD. Other secondary objectives include the use of magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS), acquired before and after final administration with CBD/THC or placebo to examine differences in brain metabolism, brain connectivity, and brain structure. Imaging analyses will focus on regional brain changes before and after administration of THC/CBD/placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain | Active comparator | Drug: Delta-9-TetrahydrocannabinolThis arm will be testing the analgesic effects of orally dosed Delta-9-Tetrahydrocannabinol on subjects with chronic non-cancer pain. |
| Cannabidiol's (CBD) effects on pain | Active comparator | Drug: CannabidiolThis arm will be testing the analgesic effects of orally dosed Cannabidiol on subjects with chronic non-cancer pain. |
| Placebo | Placebo comparator | Drug: PlacebosThis Placebo arm will act as the control as standard of care medications will be continued through the study. This arm will allow us to compare the analgesic effects of the other two arms with the standard of care treatments for chronic non-cancer pain. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18-50 yrs.
- History of cannabis use.
- 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 (11 listed)
- Current or past neurological illness.
- Substance abuse or dependence within the prior 60 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 |
|---|---|---|
| Delta-9-TetrahydrocannabinolAlso: THC, Delta-9-THCAn oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day. | Drug | Delta-9-Tetrahydrocannabinol's (Delta-9-THC) effects on pain |
| CannabidiolAlso: CBDAn 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. | Drug | Cannabidiol's (CBD) effects on pain |
| PlacebosAlso: placeboAn oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day. | Drug | Placebo |
Primary outcome
Brain Changes
Time frame: 5 days
Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at the baseline visit (day 1) and visit five (day 5) in order to determine whether the administration of Delta-9-THC, CBD, or Placebo will result in changes to these brain indices in participants with chronic pain.
1 secondary outcome
Improvement in pain relief
Time frame: 7 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- 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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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.
Deborah Yurgelun-Todd, Ph.D. principal investigator
University of Utah Brain Institute
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 Delta-9-Tetrahydrocannabinol and Cannabidiol in people with Chronic Pain, Widespread, 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 4 inclusion and 11 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 13 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
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 13 Apr 2025.