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.
Additional locations may be listed 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
