This phase II trial evaluates a kava-based intervention, AB-free kava for reduction in tobacco use and lung cancer risk. Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Unfortunately, around 16% of Florida adults continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies, partly because these cessation strategies have various adverse effects, such as suicide risk, anxiety, and insomnia. Therefore, there is an unmet and urgent need for new interventions to improve the success of tobacco cessation. Kava is a traditional beverage consumed daily by residents of the South Pacific Islands to promote relaxation, socializing and to improve the quality of sleep. Kava has been available as a dietary supplement in the United States (US) for several decades to support calm and relaxation. This study may help researchers learn whether AB-free kava may reduce tobacco use and lung cancer risk.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05081882.
Locations matching your search criteria
United States
Florida
Gainesville
UF Health Cancer Institute - GainesvilleStatus: Active
Contact: Ramzi G. Salloum
Phone: 352-294-4997
PRIMARY OBJECTIVE:
I. To examine whether AB-free kava has the potential to help facilitate tobacco cessation through evaluating reduction in urinary TNE (total nicotine equivalents, which measures nicotine, cotinine, and 3-hydroxycotinine and their conjugates separately).
SECONDARY OBJECTIVES:
I. To evaluate AB-free kava compliance and identify potential issues.
II. To examine whether AB-free kava has the potential in reducing tobacco use and tobacco dependence through analyzing tobacco cessation-related questionnaires.
EXPLORATORY OBJECTIVE:
I. To examine whether AB-free kava has the potential to reduce lung carcinogenesis induced by tobacco specific carcinogen – nicotine-derived nitrosamine ketone (NNK) (reduction in urinary 3-methyladenine [3-mA] and increase in urinary 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol [NNAL]).
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive AB-Free Kava orally (PO) three times a day (TID) for 4 weeks. Patients also undergo blood and urine collection on study.
ARM II: Patients receive placebo PO TID for 4 weeks. Patients also undergo blood and urine collection on study.
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorRamzi G. Salloum
