This phase II trial explores variables that may help or hinder a tobacco cessation strategy using flavokavain A and B (AB)-free kava. Tobacco use is the leading cause of many preventable diseases and tobacco cessation is expected to improve overall health. Kava is a traditional beverage consumed daily by residents of the South Pacific Islands to promote relaxation, to socialize and to improve sleep quality. Kava has also been available as a dietary supplement in the United States for several decades to support calm and relaxation. AB-free kava (a specialized kava supplement expected to have a better safety profile than other kava supplements) has the potential to improve rates of successful tobacco cessation. This study may help researchers learn whether AB-free kava is a useful tool for supporting tobacco cessation.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05814055.
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 evaluate AB-free kava compliance and identify potential issues.
SECONDARY OBJECTIVES:
I. To examine whether AB-free kava has the potential to help facilitate tobacco cessation – tobacco cessation-related questionnaires and reduction in urinary TNE (total nicotine equivalents, which measures nicotine, cotinine, and 3-hydroxycotinine and their conjugates separately).
II. To examine whether AB-free kava has the potential to reduce stress and improve sleep – standard questionnaires and associated biomarkers (plasma PRKACA, plasma cortisol, urinary total cortisol equivalents [TCE], and urinary N-acetyl serotonin [NAS]).
EXPLORATORY OBJECTIVES:
I. To examine the sociocultural context to better understand factors that may play a role in participants’ enrollment and willingness to engage in kava use as a dietary supplement in tobacco cessation.
II. To use a wrist wearable device to objectively monitor parameters related to sleep, which complement self-reported sleep measures.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants receive AB-free kava orally (PO) three times daily (TID) for 4 weeks. Participants also wear an accelerometer on study and undergo collection of blood samples throughout the study.
ARM II: Participants receive placebo PO TID for 4 weeks. Participants also wear an accelerometer on study and undergo collection of blood samples throughout the study.
After completion of study intervention, participants are followed up at 8 and 12 weeks.
Lead OrganizationUF Health Cancer Institute - Gainesville
Principal InvestigatorRamzi G. Salloum
