CBD for Pain Following Orthopedic Shoulder Surgery

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT06381791
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Rotator Cuff Injuries
  • Shoulder Osteoarthritis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Epidiolex — DRUG
    150mg of Epidiolex
  • Placebo oral solution — DRUG
    150mg of Placebo oral solution

Study Details

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

Key Dates

Start date
May 24, 2024
Status verified
Apr 2026
Primary completion
Dec 30, 2026
Completion
Dec 30, 2027

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Epidiolex (cannabidiol)
    Patients randomized to the Epidiolex group will take 150mg of Epidiolex with food twice daily for 14 days beginning the day of surgery.
  • Placebo Comparator: Placebo
    Patients randomized to the placebo group will take 150mg of oral placebo solution with food for 14 days beginning the day of surgery.

Primary Outcome Measure

Primary - Pain Journal [ Time Frame: 2 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Houston Methodist HospitalHoustonTexas77030
Haley M Goble, MHA, CRCC
[email protected]
7134413930
Patrick C McCulloch, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Houston Methodist Hospital· Houston, TX

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