Clinical trial NCT06381791: CBD for Pain Following Orthopedic Shoulder Surgery
Official title: Cannabidiol (CBD) As A Pain Adjunct in Orthopedic Surgical Patients: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Shoulder Osteoarthritis
Rotator Cuff Injuries
Keywords: CBD
Cannabidiol
Epidiolex
Lead sponsor: The Methodist Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: Inclusion Criteria:

* Undergoing one of the following orthopedic shoulder surgeries:

  * Total shoulder arthroplasty
  * Reverse total shoulder arthroplasty
  * Shoulder hemiarthroplasty
  * Rotator cuff repair
* 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:

* Not above 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 or 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.

Primary outcomes:
measure: Primary - Pain Journal
timeFrame: 2 weeks
Secondary outcomes:
measure: Survey Data
timeFrame: 2 weeks
measure: Pain Disability Index (PDI)
timeFrame: 2 weeks
measure: Pain, Enjoyment, General Activity (PEG) Scale
timeFrame: 2 weeks
measure: Patient Health Questionnaire 4 (PHQ-4): The four-item patient health questionnaire for anxiety
timeFrame: 2 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Patrick McCulloch, MD
role: PRINCIPAL_INVESTIGATOR
References: