Shoulder OsteoarthritisPhase 1/2CBDNCT06381791
CBD for Pain Following Orthopedic Shoulder Surgery
A Phase 1/2 study testing Epidiolex in people with Shoulder Osteoarthritis and Rotator Cuff Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Osteoarthritis, Rotator Cuff Injuries
- What is being tested?
- Epidiolex
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2024to 30 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Haley M Goble, MHA, CRCC, 7134413930, hmgoble@houstonmethodist.org
Patrick C McCulloch, MD
About this study
Official title: Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.
Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.
Participants will:
- track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.
- Complete two short surveys. Once before surgery and once after.
- Have bloodwork tested after surgery
Read the detailed description
Subjects will be randomized according to their surgery type. They will receive either the Epidiolex cannabidiol in addition to their standard of care pain regimen or a placebo in addition to their standard of care pain regimen. They will be asked to track a pain diary for 2 weeks postoperatively.
A member of the research team will conduct a follow-up telephone call on day 7 to assess subjects' drug compliance. Subjects will also be contacted for a safety monitoring call at day 7 and 1 week after completion of treatment in which they will disclose type, severity, onset, and duration of any adverse events. In addition, they will complete a suicidal assessment10 See attached safety screening document. After the 2 weeks, subjects will return the pain diary and vial of CBD/placebo at their postoperative appointment.
Subjects will also be asked to complete validated questionnaires via Houston Methodist's Redcap system once before surgery and again at 14 days postop. The surveys are with regards to sleep, activity, and pain and should take no more than 15 minutes to complete.
At their standard of care postoperative visit (11-17 days following surgery), another liver panel will be taken and their final safety monitoring screening will be conducted.
- Conditions
- Shoulder Osteoarthritis, Rotator Cuff Injuries
- Being tested
- Epidiolex, Placebo oral solution
- Keywords
- CBD, Cannabidiol, Epidiolex
- Medical subject headings
- Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EpidiolexDrug
Also called Cannabidiol Oral Solution
150mg of Epidiolex
Placebo oral solutionDrug
Also called Placebo
150mg of Placebo oral solution
| Study group | Role | What they receive |
|---|---|---|
| Epidiolex (cannabidiol) | Experimental | Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery. Receives: Drug: Epidiolex |
| Placebo | Placebo comparator | Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery. Receives: Drug: Placebo oral solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary - Pain Journal
Evaluation of postoperative pain journal responses from subjects. The pain diary will track their pain level on a Visual Analogue Scale (VAS) and their documented pain medication usage.
Measured: 2 weeks
Secondary outcomes (5)
Survey Data
Evaluation of the survey data and questionnaires from baseline to the end of the two weeks post operative period.
Measured: 2 weeks
Pain Disability Index (PDI)
This survey is designed to measure the degree to which aspects of a participant's life are disrupted by chronic pain. Each item on the survey is rated on an eleven point scale from no disability (0) to worst disability (10).
Measured: 2 weeks
Pain, Enjoyment, General Activity (PEG) Scale
This survey tracks a participant's pain intensity and pain interference. Each item on the survey is rated on an eleven point scale from 0 to 10 with different measures at either end of the scale depending on which item (intensity or interference) is being evaluated.
Measured: 2 weeks
Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety
This survey measures how frequently a patient was bothered by symptoms of anxiety or depression. It is measured on a four point scale from 0-3 with each number corresponding to how often a patient experienced a symptom with 0 being not at all, and 3 being nearly every day.
Measured: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
This survey assesses the amount and quality of sleep that a patient has experienced in the last month. It is measured both with general free response questions and scaled questions reflecting frequency or lack thereof for a given issue (rated from Not during the past month to Three or more times a week).
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start24 May 2024
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick McCulloch,MD, The Methodist Hospital Research Institute
- Investigators
- Patrick McCulloch, MD, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06381791
- Sponsor's protocol ID
- PRO00036811
- Acronym
- CBD
- Status last verified
- Apr 2026
- First submitted
- 11 Apr 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06381791
- Acronym / sponsor ID
- CBD / PRO00036811
- Conditions
- Shoulder Osteoarthritis, Rotator Cuff Injuries
- Keywords
- CBD, Cannabidiol, Epidiolex
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 24 May 2024 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 24 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of the study is to learn if Epidiolex (cannabidiol) works as a additional pain medication in patients who have had orthopedic shoulder surgery. It is also to learn about safe dosages and identify any side effects after surgery.
Researchers will compare Epidiolex to a placebo solution to see if Epidiolex lowers pain after shoulder surgery.
Participants will:
- track their pain and what medications they use every day in a provided pain diary. A researchers will call every seven days to check on the participant and diary.
- Complete two short surveys. Once before surgery and once after.
- Have bloodwork tested after surgery
Detailed description
Subjects will be randomized according to their surgery type. They will receive either the Epidiolex cannabidiol in addition to their standard of care pain regimen or a placebo in addition to their standard of care pain regimen. They will be asked to track a pain diary for 2 weeks postoperatively.
A member of the research team will conduct a follow-up telephone call on day 7 to assess subjects' drug compliance. Subjects will also be contacted for a safety monitoring call at day 7 and 1 week after completion of treatment in which they will disclose type, severity, onset, and duration of any adverse events. In addition, they will complete a suicidal assessment10 See attached safety screening document. After the 2 weeks, subjects will return the pain diary and vial of CBD/placebo at their postoperative appointment.
Subjects will also be asked to complete validated questionnaires via Houston Methodist's Redcap system once before surgery and again at 14 days postop. The surveys are with regards to sleep, activity, and pain and should take no more than 15 minutes to complete.
At their standard of care postoperative visit (11-17 days following surgery), another liver panel will be taken and their final safety monitoring screening will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- This study is designed as a randomized, double-blinded controlled trial. Patients will be recruited in clinic preoperatively prior to their scheduled procedure. Patients and the treating physician/research study team will be blinded to the treatment arm. Patients will be randomized to either the test group, which will be prescribed Epidiolex (cannabidiol) postoperatively in addition to the standard pain regimen, or the control group, which will have a placebo provided in addition to the standard pain regimen.
| Arm | Type | Receives |
|---|---|---|
| Epidiolex (cannabidiol) | Experimental | Drug: EpidiolexPatients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery. |
| Placebo | Placebo comparator | Drug: Placebo oral solutionPatients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EpidiolexAlso: Cannabidiol Oral Solution150mg of Epidiolex | Drug | Epidiolex (cannabidiol) |
| Placebo oral solutionAlso: Placebo150mg of Placebo oral solution | Drug | Placebo |
Primary outcome
Primary - Pain Journal
Time frame: 2 weeks
Evaluation of postoperative pain journal responses from subjects. The pain diary will track their pain level on a Visual Analogue Scale (VAS) and their documented pain medication usage.
5 secondary outcomes
Survey Data
Time frame: 2 weeks
Pain Disability Index (PDI)
Time frame: 2 weeks
Pain, Enjoyment, General Activity (PEG) Scale
Time frame: 2 weeks
Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety
Time frame: 2 weeks
Pittsburgh Sleep Quality Index (PSQI)
Time frame: 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick McCulloch, MD principal investigator
The Methodist Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Epidiolex in people with Shoulder Osteoarthritis and Rotator Cuff Injuries, run by The Methodist Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haley M Goble, MPH, CRCC (7134413930, hmgoble@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary - Pain Journal (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.