Hemp compound tested for spinal cord injury pain relief
NCT ID NCT05630235
First seen Jun 27, 2026 · Last updated Aug 14, 2026 · Updated 1 time
Summary
This small early-phase trial tests whether a single oral dose of a hemp-derived CBD/CBD-A extract can reduce neuropathic pain and change brain activity in people with spinal cord injury. Six participants with moderate to severe nerve pain for at least three months will receive either the extract or a placebo. The study measures pain intensity, unpleasantness, and brain electrical patterns using EEG.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- hemp-derived cannabidiol (CBD) and cannabidiolic-acid (CBD-A) oral extract
- What this could lead to
- If it works, this could point toward a new option for managing chronic nerve pain after spinal cord injury.
- What could go wrong
- This is a very small, early-phase trial with only 6 participants, so results may not apply widely. The one-time dose may not reflect real-world use, and side effects are not yet well understood.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
6 people
The number who actually took part.
- Started
-
Jun 2025
- Finished
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Aug 2026
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 64 years
- Sex
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Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Men or Women; 2. 18-64 years of age with an incomplete or complete acquired traumatic SCI; 3. 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); 4. 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). 5. Must have previous experience with consuming cannabis and or cannabinoids. Exclusion Criteria: 1. Current drug (DAST-10: \>6) or alcohol abuse (AUDIT: \>10); 2. Current use of cannabis plant or cannabis products (CBD or CBD+THC) or any other drugs of abuse (unless prescribed) including alcohol; 3. Presence of significant medical illness (e.g., diabetes, obesity, cardiovascular disease, hypertension, hepatitis) or other significant neurological trauma; 4. 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; 5. 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; 6. 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; 7. Have a history of renal or hepatic disease: or 8. Have elevated serum creatinine above the laboratory upper limit of normal (ULN): or 9. Have elevated serum transaminases (ALT or AST) above the ULN: or 10. Have elevated total bilirubin above the ULN; or 11. Take valproate, due increased risk of liver enzyme elevation; or 12. Currently using strong CYP2C19 and CYP3A4 inducers; or 13. Have suicidal ideation (subjects should be screened for suicidal ideation); or 14. Cannot abstain from the use of alcohol during the study period, due to increased risk of sedation; or 15. Have a known or suspected hypersensitivity to cannabidiol or tetrahydrocannabinol. 16. Have a known or suspected hypersensitivity to sesame seed oil, lecithin, or bovine gelatin.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Lynn Rehabilitation Center
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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