SCI - Spinal Cord InjuryPhase 1/2NCT05630235
Effects of CBD/CBD-A Oral Extract on Resting-state EEG and Neuropathic Pain Symptoms After SCI
A Phase 1/2 study testing CBD/CBD-A in people with SCI - Spinal Cord Injury and Neuropathic Pain, run by University of Miami at 1 site in United States.
Trial summary
The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG). Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- SCI - Spinal Cord Injury, Neuropathic Pain
- What is being tested?
- CBD/CBD-A
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jun 2025to 13 Aug 2026
- Phase
- Phase 1/2
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men or Women;
- 18-64 years of age with an incomplete or complete acquired traumatic SCI;
- Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);
- The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).
- Must have previous experience with consuming cannabis and or cannabinoids.
Who cannot join
- Current drug (DAST-10: >6) or alcohol abuse (AUDIT: >10);
- Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
- Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
- History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;
- Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners;
- Current pregnancy. Pregnancy will be evaluated using a pregnancy test during the first study visit. Female subjects of childbearing potential will be required to use two forms of effective birth control for the 3 months prior to participating in the study and continuing for 1 month after completion of the study;
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- Have a history of renal or hepatic disease: or
- Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or
- Have elevated serum transaminases (ALT or AST) above the ULN: or
- Have elevated total bilirubin above the ULN; or
- Take valproate, due increased risk of liver enzyme elevation; or
- Currently using strong CYP2C19 and CYP3A4 inducers; or
- Have suicidal ideation (subjects should be screened for suicidal ideation); or
- Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or
- Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol.
- Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Hemp-derived Cannabidiol and Cannabidiolic-acid Oral Extract on Resting-state Electroencephalography and Neuropathic Pain Symptoms in People With Spinal Cord Injury
The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).
- Conditions
- SCI - Spinal Cord Injury, Neuropathic Pain
- Being tested
- CBD/CBD-A, Placebo
- Medical subject headings
- Spinal Cord Injuries, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBD/CBD-ADrug
Participants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally.
PlaceboOther
The placebo equivalent of the CBD/CBD-A dose administered orally.
| Study group | Role | What they receive |
|---|---|---|
| CBD/CBD-A followed by placebo group | Experimental | Participants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period. Receives: Drug: CBD/CBD-A; Other: Placebo |
| Placebo followed by CBD/CBD-A group | Experimental | Participants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period. Receives: Drug: CBD/CBD-A; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropathic pain intensity or unpleasantness.
Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).
Measured: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Change in brain electrocortical activity at rest.
Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis
Measured: Baseline and 3 hours post intervention
Secondary outcomes (4)
Change in neuropathic pain symptoms severity using the NPSI.
The Neuropathic Pain Symptom Inventory (NPSI) will assess the presence and severity of common neuropathic pain symptoms. Range 0-100 with higher scores representing greater neuropathic pain symptoms.
Measured: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Change in sensory function using QST.
Sensory function will be assessed using quantitative sensory testing (QST) using an FDA-approved Thermal Sensory Analyzer.
Measured: Baseline and 3 hours post intervention
Change in state anxiety using the STAI.
Using the State-trait Anxiety Inventory (STAI), we will evaluate changes in momentary anxiety with scores ranging from 5-20. Higher values equate to greater anxiety symptoms.
Measured: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Subjective Drug Effects
Drug Effects Questionnaire (DEQ): The DEQ is a brief five item instrument used to assess subjective drug effects. The five items are presented on a 100 mm visual analogue scale ranging from not at all to extremely. The participants are instructed to draw a vertical line at any place between the two responses
Measured: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start16 Jun 2025
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Consortium for Medical Marijuana Clinical Outcomes Research
- Responsible party
- Principal investigator, Eva Widerstrom-Noga, University of Miami
- Investigators
- Eva Widerstrom-Noga, PhD, DDS, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05630235
- Sponsor's protocol ID
- 20220782
- Status last verified
- Aug 2026
- First submitted
- 18 Nov 2022
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Hemp-derived Cannabidiol and Cannabidiolic-acid Oral Extract on Resting-state Electroencephalography and Neuropathic Pain Symptoms in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05630235
- Acronym / sponsor ID
- 20220782
- Conditions
- SCI - Spinal Cord Injury, Neuropathic Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Consortium for Medical Marijuana Clinical Outcomes Research
- Study start
- 16 Jun 2025 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 29 Nov 2022 (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.
The main purposes of this study are to (1) measure the effect of CBD/CBD-A on pain symptoms, pain intensity, pain unpleasantness, and skin sensitivity to hot and cold temperatures; and (2) measure the effect of CBD on brain electrical activity with electroencephalography (EEG).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBD/CBD-A followed by placebo group | Experimental | Drug: CBD/CBD-A, Other: PlaceboParticipants in this group will receive a one time dose of CBD/CBD-A on visit 2, followed by a placebo on visit 3 after a two-week period. |
| Placebo followed by CBD/CBD-A group | Experimental | Drug: CBD/CBD-A, Other: PlaceboParticipants in this group will receive a placebo on visit 2, followed by a one time of CBD/CBD-A on visit 3 after a two-week period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Men or Women;
- 18-64 years of age with an incomplete or complete acquired traumatic SCI;
- Must have experienced neuropathic pain for a minimum of three months before entering the study (neuropathic pain will be assessed using the International SCI Pain Classification);
- The pain intensity must be in the moderate to severe category, which will be defined as a score of at least four on an NRS (range of 0 to 10).
- Must have previous experience with consuming cannabis and or cannabinoids.
Key exclusion criteria (16 listed)
- Current drug (DAST-10: >6) or alcohol abuse (AUDIT: >10);
- Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol;
- Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma;
- History of or current severe psychopathology (e.g., major depressive disorder, bipolar disorder, schizophrenia, post-traumatic stress disorder) judged by the investigator to put the subject at greater risk of experiencing an adverse event;
- Adults who are unable to consent, women who are pregnant, breastfeeding, or not practicing an effective form of birth control (condoms, diaphragm, birth control pill, IUD), and prisoners;
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 |
|---|---|---|
| CBD/CBD-AParticipants will be administered a one-time dose of 204.6 mg of CBD/CBD-A orally. | Drug | CBD/CBD-A followed by placebo group, Placebo followed by CBD/CBD-A group |
| PlaceboThe placebo equivalent of the CBD/CBD-A dose administered orally. | Other | CBD/CBD-A followed by placebo group, Placebo followed by CBD/CBD-A group |
Primary outcome
Change in neuropathic pain intensity or unpleasantness.
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Assess changes in pain intensity and unpleasantness of the worst neuropathic pain using a numerical rating scale from 0-10 (0 no pain and 10 worst imaginable/unpleasant pain).
Change in brain electrocortical activity at rest.
Time frame: Baseline and 3 hours post intervention
Assess brain electrocortical activity at rest using a 64-channel Biosemi EEG system and conducting EEG power spectrum analysis
4 secondary outcomes
Change in neuropathic pain symptoms severity using the NPSI.
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Change in sensory function using QST.
Time frame: Baseline and 3 hours post intervention
Change in state anxiety using the STAI.
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
Subjective Drug Effects
Time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention
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 14 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Eva Widerstrom-Noga, PhD, DDS principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CBD/CBD-A in people with SCI - Spinal Cord Injury and Neuropathic Pain, run by University of Miami 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 5 inclusion and 16 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 14 Aug 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Change in neuropathic pain intensity or unpleasantness. (time frame: Baseline, approximately 3 hours post intervention, and approximately 6 hours post intervention). The study lists 2 primary outcomes in all. 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 14 Aug 2026.