Clinical Trials

Inclusion Criteria: 

• 18 years of age or older.
• Surgical services nurses at Mayo Clinic in Rochester, MN.
• Able to participate fully in all aspects of the study.
• Willing to use birth control for the duration of the study (if of childbearing potential). Understood and signed study informed consent.

Exclusion Criteria:

• Pregnant, nursing, or trying to conceive.
• Persons with a menstrual cycle who are not willing and able to use an approved contraceptive during the study (female sterilization (tubal ligation, hysterectomy), IUD or another implant, oral or injectable contraceptive, contraceptive patch/ring, diaphragm/cervical cap, male sterilization (vasectomy), male condom, female condom, sponge/spermicide) (Persons who do not have sex with men can participate without the use of an approved contraceptive).
• Use of kava or kava-containing products within the past 8 weeks.
• Any prior adverse reaction or known sensitivity or allergy to kava or related botanicals (peppers).
• Use of acetaminophen that cannot be discontinued or replaced with an NSAID during the study.
• Use of oral corticosteroids (e.g., hydrocortisone) or other steroids (e.g., prednisone).
• Alcohol use greater than 1 drink per day.
• Use of kratom within the past 8 weeks.
• Recent history of clinical depression or anxiety diagnosis.
• Known significant liver disease or dysfunction.
• Known significant kidney disease or dysfunction.
• Known Addison’s or Cushing’s Disease.
• Known catecholamine imbalance or medication use which influences catecholamine levels.
• History or current diagnosis of cancer (except for successfully treated basal cell carcinoma diagnosed less than 5 years prior to screening or cancer in full remission more than 5 years after diagnosis).
• Recent history or acute disease or unstable medical condition.
• Surgery planned during the course of the trial.
• A known history of any condition or factor judged by the investigator to preclude participation in  the study or which might hinder adherence.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 6/19/23. Questions regarding updates should be directed to the study team contact.