CBD for Pain Following Orthopedic Shoulder Surgery

NCT06381791 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PRO00036811
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Shoulder Osteoarthritis; Rotator Cuff Injuries

Keywords

CBD; Cannabidiol; Epidiolex

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Secondary Outcomes (5)

• Survey Data

  2 weeks

• Pain Disability Index (PDI)

  2 weeks

• Pain, Enjoyment, General Activity (PEG) Scale

  2 weeks

• Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety

  2 weeks

• Pittsburgh Sleep Quality Index (PSQI)

  2 weeks

Study Arms (2)

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.

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.

Drug: Placebo oral solution

Interventions

Epidiolex DRUG

150mg of Epidiolex

Also known as: Cannabidiol Oral Solution

Epidiolex (cannabidiol)

Placebo oral solution DRUG

150mg of Placebo oral solution

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Patrick McCulloch, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haley M Goble, MPH, CRCC

CONTACT

7134413930; hmgoble@houstonmethodist.org

David N Armond, BS

CONTACT

3462380206; dnarmond@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The John S. Dunn Chair in Orthopedic Surgery

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: April 24, 2024
• Study Start: May 24, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)