Could CBD help people with MS sleep better and hurt less?

NCT ID NCT05269628

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This study investigates whether cannabidiol (CBD), a compound from cannabis, can improve sleep and reduce pain in people with multiple sclerosis (MS) who also have chronic pain. About 166 participants take CBD or a placebo for several weeks while their sleep is measured in a lab and at home. The goal is to see if CBD makes sleep more regular and less interrupted, and whether better sleep leads to less pain.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cannabidiol (CBD) oral solution
What this could lead to
If successful, this could point toward a new way to treat sleep problems and chronic pain in people with multiple sclerosis.
What could go wrong
This is a mid-stage trial with a moderate number of participants, so results may not apply to everyone. CBD may cause side effects like drowsiness or liver issues.

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 166 people

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

Started

Mar 2022

Expected to finish

Aug 2027

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 65 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. Patients with clinically definite MS (those who are on a disease modifying therapy must be on a stable dose without evidence of liver toxicity for at least 3 months); 2. Presence of chronic pain defined as moderate to severe pain for at least 3 months, based on a 0-10 numeric rating scale (NRS); 3. Willingness to maintain stable analgesic regimen during study period; 4. Recent serum aspartate transaminase, alanine transaminase, and bilirubin testing within 90 days of screening; Exclusion Criteria: 1. Current shift work sleep disorder, or narcolepsy diagnosed with polysomnography and multiple sleep latency test; 2. History of MS relapse within the last 30 days prior to screening (participants will be considered eligible after the 30-day window); 3. Pain due to cancer; 4. Pregnancy or breastfeeding; 5. Current cannabinoid use (participants may be reconsidered for inclusion after 30-day washout) and/or unwillingness to abstain from cannabinoids in any form from 30 days prior to the study of the study drugs and until the last follow up phone call at the end of the study (30 - 37 days after taking the last dose of the study drug). 6. Unwillingness to use contraception from screening until the end of drug treatment 7. Current suicidal ideation (SI) with intent and/or plan; these individuals will be assessed by a study psychologist and referred for urgent mental health treatment as indicated; 8. Current severe depression as indicated by a PHQ-9 score of ≥ 17 that includes indicators of significant depressed mood (sum of items #1 and #2 ≥ 5). 9. History of mania or schizophrenia diagnosis 10. Known hypersensitivity to cannabinoids in general, or Epidiolex® or Dronabinol specifically or its excipients (e.g., sesame oil) 11. History of the following cardiovascular conditions: recent myocardial infarction or stroke (last 6 months prior to screening), unstable angina, left ventricular hypertrophy, mitral valve prolapses, severe coronary artery disease, NYHA class III or IV congestive heart failure. 12. History severe hepatic impairment (must have blood AST ≤ 2.0x ULN, ALT ≤ 2,0x ULN, and bilirubin ≤ 1.5x ULN within the last 90 days (AST, ALT, bilirubin testing will be required within 90 days of screening); 13. History of seizure disorder (recurrent, unprovoked seizures not explained by a known reversible cause) or history of certain types of head injury that could cause an increased risk of seizures; 14. History of prescription or illicit drug abuse (such as cocaine, amphetamine, methamphetamine, heroin); 15. Current risk for alcohol misuse as indicated by a score of ≥ 8 on the Alcohol Use Disorders Identification Test (AUDIT) self-report measure. 16. Current warfarin, valproate or clobazam use. 17. Current use of known moderate or strong inhibitors of CYP3A4 \[topical ketoconazole, and temporary (\<= 4 week) oral courses of clarithromycin, fluconazole and itraconazole will be allowed\]. 18. Current use of strong inducers of CYP3A4 or CYP2C19 (does not include glucocorticoids or modafinil/armodafinil, which are permitted), 19. Current use of moderate or strong inhibitors/inducers of CYP2C9, and narrow therapeutic index drugs (e.g., cyclosporine, amphotericin B). 20. Current use of known non-minor Sensitive CYP2C19 Substrates, with the exception of some proton pump inhibitors (e.g., esoprazole, omeprazole)), periodic self-limited courses of diazepam (e.g., for MRI sedation) and submaximal doses of some antidepressant class medications (e.g., citalopram, and escitalopram), which will be permitted by the discretion of the treating neurologist PI. 21. Refusal to avoid grapefruit or grapefruit products during the study treatment interval. 22. Current use of opioids (tramadol permitted). 23. Employed as a commercial driver or employed in an occupation that involves extreme heights or use of heavy machinery. 24. History of car crashes or near-crashes due to untreated sleepiness that has led to near-misses in the past 6 months. 25. Cognitive dysfunction as indicated by \>=3 errors on the six-item cognitive screener 26. Expanded Disability Status Scale (EDSS) score \>=8.0. 27. Blood pressure at screening above 180 mmHg systolic and/or 120 mmHg diastolic, or below 90 mmHg systolic and or 60 mmHg diastolic, or history of syncope related to orthostatic hypotension; 28. Resting heart rate at screening less than 50 bpm or greater than 100 bpm; 29. Any other treatment or medical, neurological, sleep, or psychiatric condition that, in the opinion of the investigators, could affect participant safety or eligibility.

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • University of Michigan

    RECRUITING

    Ann Arbor, Michigan, 48109, United States

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