Kava for Anxiety and Stress

Overseen By Naomi Fujioka, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Masonic Cancer Center, University of Minnesota

Must not be taking: Benzodiazepines, High-intensity statins

Disqualifiers: Liver disease, Pregnancy, Substance use, others

Compensation: Varies

Number of Visits: 2

43 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a pilot, two-arm, randomized, blinded, placebo-controlled cross-over clinical trial to study the safety and effect of 14 days of kava on anxiety and physiologic stress in survivors of cancer and its treatment. Participants will be randomized to take either kava first or placebo first. Kava 75 mg or placebo will be taken three time daily (TID) for 14 days (Period 1), followed by a washout period of 14-28 days. Thereafter, the participant will take either placebo or kava TID for 14 days (Period 2), whichever he/she did not take in Period 1.

Eligibility Criteria

This trial is for cancer survivors who've finished curative treatment within the last 2 years, have mild anxiety with a GAD-7 score of ≥5, and are in good physical condition (ECOG 0-1). They must have normal kidney/liver function and agree not to use benzodiazepines or alcohol during the study. It's not suitable for those unable to consent or follow the protocol.

Inclusion Criteria

Score of ≥ 5 on the GAD-7 questionnaire, considered to be mild anxiety

Ability to provide written, informed consent

My kidney and liver tests were normal within the last month.

Exclusion Criteria

Known allergy to kava

Significant uncontrolled conditions or situations, which in the judgment of the enrolling investigator, could affect safety and/or ability to adhere to study requirements

Regular use of alcohol, defined as ≥ 3 times per week, regardless of amount, within 14 days prior to study registration

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either kava or placebo three times daily for 14 days

2 weeks

1 visit (in-person)

Washout

Participants undergo a washout period to clear the effects of the first treatment

2-4 weeks

Treatment Period 2

Participants receive the alternate treatment (kava or placebo) three times daily for 14 days

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Kava

Trial Overview The trial tests if Kava can reduce anxiety and stress over a two-week period compared to a placebo. Participants take either Kava or placebo three times daily for 14 days, followed by a break, then switch treatments for another 14 days in this cross-over design.

Participant Groups

Group I: Kava Experimental Treatment 1 Intervention

75mg of Kava taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days.

Group II: Placebo Placebo Group 1 Intervention

The placebo will be taken three times daily for 14 days. Participants will then enter into a washout period of 14-28 days.

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+