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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether kava, a plant-based supplement, can reduce anxiety and stress in individuals who have recently completed cancer treatment. Participants will take both kava and a placebo (a harmless sugar pill) to determine if kava makes a difference. The trial is open to those who finished treatment for certain types of cancer within the last two years, currently experience mild anxiety, and can avoid alcohol and certain medications during the study. The research aims to determine if kava is safe and effective for easing anxiety in these individuals. As an Early Phase 1 trial, the study focuses on understanding how kava works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

The trial requires you to stop using benzodiazepines and alcohol during the study and for at least 14 days after. If you regularly use these or certain other medications, you may need to stop before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that kava might help reduce anxiety. However, safety concerns exist. Some studies have found that kava does not affect mental alertness or cause drowsiness when used short-term. However, reports have linked kava use to liver problems. For people with mild anxiety, kava has shown benefits when used for less than 24 weeks. Due to the risk of liver issues, caution is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for anxiety?

Unlike the standard treatments for anxiety and stress, like SSRIs (selective serotonin reuptake inhibitors) and benzodiazepines, Kava offers a natural alternative derived from the roots of the kava plant. Researchers are excited about Kava because it contains kavalactones, which may help reduce stress and anxiety by interacting with the brain's neurotransmitters in a unique way, potentially offering calming effects without the sedative side effects often associated with traditional medications. Additionally, Kava could show results in just days, providing quicker relief compared to some options that can take weeks to become effective.

What evidence suggests that kava might be an effective treatment for anxiety and stress?

Research has shown that kava extract can help reduce anxiety symptoms. In this trial, participants will receive either kava or a placebo. Some studies have found kava to be more effective than a placebo, which contains no active ingredients, in treating anxiety. About 88% of kava users report feeling less stressed and more relaxed. Those who feel nervous or restless often see the best results. While kava seems more effective for short-term anxiety, some people may experience side effects like drowsiness or sweating. Overall, kava appears to be a promising natural option for managing anxiety. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/10653213/

Efficacy of kava extract for treating anxiety These data imply that kava extract is superior to placebo as a symptomatic treatment for anxiety. Therefore, kava extract is an herbal treatment option for ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0378874125013091

Prevalence and Use Patterns of Kava (Piper methysticum) ... Kava was rated as effective for stress relief and relaxation by 88% of users. •. Drowsiness and sweating were the most reported side effects.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33207379/

Kava (Piper methysticum) Extract for the Treatment of ... The most effective results were seen for nervous tension and restlessness, with better effects in patients with acute versus chronic complaints.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388118301981

A systematic review and analysis of randomized clinical trials Results. Kava Kava was shown to be more effective than placebo in 3 of the 7 trials. A final risk ratio of 1.50 (95% CI: ...

5. digitalcommons.pcom.edu digitalcommons.pcom.edu/pa_systematic_reviews/83/

"Is Kava (Piper Methysticum) Safe and Effective for Reducing ... Results from the Conner et al study indicate that Kava use is effective in reducing anxiety in individuals with low baseline anxiety, but there were no ...

6. cdph.ca.gov cdph.ca.gov/Programs/CEH/DFDCS/CDPH%20Document%20Library/FDB/FoodSafetyProgram/KavaFactSheet.pdf

Consumer Fact Sheet—Kava - CDPH Additionally, FDA published a memorandum which concluded that sufficient toxicological data demonstrates that kava is not safe for human ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/11994028/

A systematic review of the safety of kava extract in ... Controlled trials suggest that kava extracts do not impair cognitive performance and vigilance or potentiate the effects of central nervous system depressants.

8. fda.gov fda.gov/media/169556/download

Scientific Memorandum: Kava (8/11/2020) Although there is some scientific evidence for the use of kava to treat anxiety, safety concerns over hepatotoxicity has resulted in withdrawal ...

9. aafp.org aafp.org/pubs/afp/issues/2008/0815/p433.html

Safety of Kava for Patients with Mild Anxiety Disorders We found solid evidence that kava, when taken for mild-to-moderate generalized anxiety disorder (GAD) for less than 24 weeks, produced significant reductions ...