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Kava

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

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

Placebo

Naomi Fujioka, MD

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.

Effect of Kava on Anxiety and Stress in Cancer Survivors

De-identified data will be shared amongst the study team via Box.

PROMIS- 29 questionnaire will be administered to determine anxiety level. Scale 4-20. Higher score indicates higher anxiety.

Masonic Cancer Center, University of Minnesota

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.

Participants on this arm will take one placebo capsule orally three times daily for 28 days.

Melissa Malham

Nicole Davila

Ramzi Salloum, PhD

Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians.

This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.

Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava

Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses

Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Effect of Kava on Anxiety and Stress in Cancer Survivors	NCT06213298	Kava Anxiety Stress Cancer Depression Sleep	Kava Placebo	18 Years -	Masonic Cancer Center, University of Minnesota
Effect of Kava on Anxiety and Stress in Cancer Survivors	NCT06213298	Kava Anxiety Stress Cancer Depression Sleep	Kava Placebo	18 Years -	Masonic Cancer Center, University of Minnesota
Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava	NCT05081882	Smoking	Kava Placebo	21 Years - 99 Years	University of Florida

Spots Global Cancer Trial Database for kava

Every month we try and update this database with for kava cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for kava

Every month we try and update this database with for kava cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for kava cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.