Is NCT06234631 recruiting in Ann Arbor, MI?

Yes, NCT06234631 is currently recruiting participants at its Ann Arbor, MI location. This knee osteoarthritis clinical trial is actively enrolling qualified participants.

How do I join the knee osteoarthritis clinical trial in Ann Arbor?

To join this clinical trial in Ann Arbor, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Ann Arbor clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Knee Osteoarthritis Clinical Trial in Ann Arbor, MI

About This Knee Osteoarthritis Study in Ann Arbor

The goal of this study is to better understand how daily treatment with cannabidiol (CBD) affects the need for opioid pain medication, as well as pain, inflammation and other related symptoms, after knee replacement surgery. The information collected in this study is necessary to help understand whether CBD may be a useful medication before and/or after surgery. The study hypothesis is that CBD exerts opioid-sparing effects through anti-inflammatory, analgesic, and anxiolytic mechanisms.

Sponsor: Chad Brummett

Who Can Participate

Inclusion Criteria

Willing and able to read, understand, and sign the informed consent (English)

Willingness to participate in all study measures and restrictions, including patient-reported outcomes and longitudinal follow-up

Scheduled for surgery: primary total knee arthroplasty

Primary diagnosis of osteoarthritis of the surgical knee

Individuals of reproductive potential must agree to use acceptable birth control (defined in manual of operating procedures). This includes currently practicing an effective form of two types of birth control for women of childbearing potential, which are defined as those, alone or in combination, that result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly from the screening visit until 28 days after the last study drug administration.

Participants must also agree not to donate sperm or eggs during study drug administration

Ability to take and to swallow the study medication and be willing to adhere to the treatment regimen

Agreement to adhere to Lifestyle Considerations (see protocol) throughout study duration

Exclusion Criteria

Revision or bilateral total knee arthroplasty

Individuals receiving or actively applying for worker's compensation or disability and other aspects associated with potential secondary gain (postoperative disability for recovery is permitted)

Severe physical impairment or clinically significant illness (e.g., blindness, paraplegia)

Co-morbid medical conditions that may significantly impair physical functional status (e.g., current non-skin malignancies, solid organ transplant in the past year)

Illicit drug use (other than cannabis). Unreported opioid use would be exclusionary but reported prescribed opioid use is allowed (e.g. patient denies opioid use but is found to be positive on the urine drug screen)

Self-reported use of cannabis products within the 7 days prior to starting study drug

Self-reported use of cannabis products within the 8-30 days prior to starting study drug AND either a failed drug screen or inability to confirm successful washout (Note - may be rescreened with appropriate wash-out period)

High daily preoperative opioid dose

Individuals with major neurological disorders, such as dementia, Parkinson's disease, cognitive impairment, epilepsy, history of traumatic brain injury/head injury, and seizures

Individuals with significant illness (e.g., cancer) and/or clinically significant labs (e.g. labs measured by complete blood count (CBC) and basic chemistry with values meaningfully outside of the normal range \[abnormal levels to be reviewed by the Principal Investigator or prescribing provider\])

Medical or psychiatric conditions that in the judgment of study personnel would preclude participation in this study (e.g., psychosis, suicidal ideation; note that stable anxiety and depression are not exclusions)

Pregnant or nursing women (total joint arthroplasty is typically not indicated in this group of patients)

Self-reported liver cirrhosis

Self-reported uncontrolled diabetes

Self-reported active hepatitis (any etiology, including infectious, autoimmune, or alcohol-related)

Blood pressure at screening above 180 millimeters of mercury (mmHg) systolic and/or 120 mmHg diastolic; if value exceeds the set point, potential participants will have repeat assessment within 5 minutes for up to two additional measurements.

Resting heart rate at screening less than 50 beats per minute (bpm) or greater than 100 bpm; if value exceeds the set point, potential participants will have repeat assessment within 5 minutes for up to two additional measurements.

Elevated liver enzymes and bilirubin (measured by blood test at screening)

Serum total bilirubin ≥ 2.5 milligrams (mg) per deciliter (dL) (mg/dL); or,

Alanine transaminase (ALT) or Alanine transaminase (AST) ≥ 3x upper limit normal (ULN); or,

Alkaline phosphatase ≥ 2x ULN

Severe cardiovascular disease (e.g., current unstable angina, current congestive heart failure, or current severe valvular abnormalities) that is self-reported by patient or in medical record

Current valproate, clobazam, or warfarin use per self-report or medical records

Current use of strong inducers of cytochrome p450 (CYP) enzymes CYP3A4 and CYP2C19, or CYP2C19 substrates with a narrow therapeutic index

Self-reported allergies to sesame oil, strawberries, opioids, or cannabis/cannabinoids and confirmed by the investigator during screening

Any impairment, activity, behavior, or situation that in the judgment of the study team would prevent satisfactory completion of the study protocol

Self-reported severe side effects to opioids precluding the use of opioids for post-surgical pain and/or clear plan not to use any opioids after surgery and confirmed by the investigator during screening

Participation in other clinical trials over the course of this study (note: outside of active period is permissible as determined by the investigator during screening)

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT06234631) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Knee Osteoarthritis Treatment Options in Ann Arbor, MI

If you're searching for knee osteoarthritis treatment options in Ann Arbor, MI, this clinical trial (NCT06234631) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced knee osteoarthritis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all knee osteoarthritis clinical trials near you to find additional studies recruiting in your area.

Knee Osteoarthritis Clinical Trial in Ann Arbor, MI

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