Could CBD oil soothe restless legs? new study seeks answers
NCT ID NCT07224932
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a high-CBD cannabis extract is safe and helps relieve symptoms in people with moderate to severe restless legs syndrome (RLS). About 60 adults aged 18-79 will receive either the CBD extract or a placebo for several weeks. Researchers will track side effects and changes in RLS severity to see if the treatment is well-tolerated and effective.
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
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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Feb 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 79 years
- Sex
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Anyone
- Healthy volunteers
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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. Male or female subjects between 18 and 79 years of age, inclusive. 2. Willing and able to give informed consent. 3. Idiopathic RLS, meeting all 4 International RLS Study Group diagnostic criteria. 4. Moderate or severe symptoms, defined as an IRLS score ≥ 15 at screening visit. 5. RLS medications unchanged for 4 weeks prior to baseline. 6. Must have a driver or available transportation (including provided Uber vouchers) to drive them to and from study visits and for other transportation needs during the treatment period. 7. Has a significant other, caregiver, or close acquaintance who knows the subject well and agrees to participate in the subject's neuropsychiatric assessment. 8. Agrees to not take more than 1 gram per day of acetaminophen. 9. Whereas applicable, agrees to utilize an effective method of contraception from screening through at least 4 weeks after the completion of study treatment. Exclusion Criteria: 1. Secondary RLS, such as Parkinson's disease or end-stage renal disease. 2. Present or past history of another severe sleep disorder. 3. Currently on night shift work schedule. 4. History or diagnosis of schizophrenia, bipolar or a psychotic disorder, severe depression, or any mental health illness that would compromise the safety of the participant. 5. Current suicidal ideation. 6. Severe cognitive impairment (e.g., Alzheimer's Disease, traumatic brain injury). 7. Uncontrolled hypertension. 8. Known or suspected allergy or hypersensitivity to cannabinoids or excipients used in the study drug formulation. 9. Pending legal action or workers compensation. 10. Cannabis use (THC) detectable at the screening/baseline visits. 11. History of drug or alcohol dependence. 12. Use of dopamine blockers, cocaine, or MAO-A inhibitors within 90 days of baseline. 13. Use of any drugs with known interactions with cannabinoids (e.g., tolcapone, clopidogrel, felbamate, warfarin, barbiturates, benzodiazepines, niacin, nicotinamide, isoniazid, ketoconazole, clobazam, valproate, mTOR inhibitors) within 90 days of baseline. 14. Unstable medical condition. 15. Clinically significant laboratory abnormalities. 16. Moderate or severe hepatic impairment. 17. Is pregnant, lactating, or has a positive pregnancy test result pre-dose. 18. Planned elective surgery during study participation.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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More trials for these conditions
Other studies related to the condition(s) this trial covers.