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Could CBD be the next painkiller for shoulder surgery patients?

NCT ID NCT06381791

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tests whether Epidiolex (a CBD medicine) can help control pain after shoulder surgery when added to standard painkillers. About 80 adults having rotator cuff repair will take either CBD or a placebo for two weeks after surgery. They will track their pain and medication use daily, and researchers will check for side effects and changes in pain-related disability.

What this could mean

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

Active substance
Cannabidiol (Epidiolex)
What this could lead to
If it works, this could point toward a safe, non-opioid option for managing pain after orthopedic surgery.
What could go wrong
This is an early-phase trial with only 80 people, so results may not apply to everyone. CBD can cause side effects like drowsiness or liver issues, and it may not reduce pain better than a placebo.

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

About 80 people

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

Started

May 2024

Expected to finish

Dec 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 years and older

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: * Above the age of 18 years old * Undergoing a rotator cuff repair surgery * Receiving standard anesthesia during surgery * If a subject is of reproductive potential, they must be on effective contraception one month prior, during treatment, and one month following treatment. Exclusion Criteria: * Under the age of 18 years old * History of revision shoulder arthroplasty * History of liver disease or impairment * Are currently taking valproate or clobazam * Are currently taking a moderate/strong CYP3A4 or CYP2C19 inhibitor * Are currently taking a strong CYP3A4 or CYP2C19 inducer * Are currently taking narcotics * History of substance/alcohol abuse * Those currently or previously under the care of a pain management specialist * History of marijuana/cannabidiol (not including topical) regular use within the past 6 months * Allergy related to cannabidiol * Allergy related to sesame seeds * Pregnancy (As part of standard of care, all female participants will be administered a urine pregnancy test prior to surgery. A negative test result is required to participate in the study.) * If you are taking any medications with known risks for suicidal behavior and ideation * If you have a diagnosed psychiatric disorder * If you are untreated for a diagnosed sleeping disorder * If you are actively breastfeeding * Patients currently taking central nervous system (CNS) depressants * Patients currently taking other drugs with known hepatotoxicity * Vulnerable populations. Patients taking concomitant medications which are substrate of uridine 5'-diphospho-glucuronosyltransferase 1-9 (UGT1A9), uridine diphosphate-glucuronosyltransferase 2B7 (UGT2B7), CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, and P-gp will be monitored for potential adverse events based on the Epidiolex® label for the concomitant medication being used.

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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

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

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