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NCT06177535 | RECRUITING | Stress

A Study of Oral Kavalactones Effect on Nurses
Sponsor:

Mayo Clinic

Information provided by (Responsible Party):

Brent A. Bauer

Brief Summary:

This research study is being done to assess the impact of taking Kava extract (Piper methysticum), a dietary supplement on cortisol in a healthy nursing population.

Condition or disease

Stress

Intervention/treatment

Kavalactones

Placebo

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : DOUBLE
Primary Purpose : SUPPORTIVE_CARE
Official Title : The Effect of Oral Kavalactones on Cortisol, Measures of Burnout, and Motivation in Nurses
Actual Study Start Date : 2025-07-15
Estimated Primary Completion Date : 2025-10
Estimated Study Completion Date : 2025-10

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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.
A Study of Oral Kavalactones Effect on Nurses

Location Details

NCT06177535

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Locations

RECRUITING

United States, Minnesota

Mayo Clinic Minnesota

Rochester, Minnesota, United States, 55905