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Could CBD oil soothe restless legs? new study seeks answers

NCT ID NCT07224932

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 60 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Feb 2026

An estimate. End dates often move.

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 79 years

Sex

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

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

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