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

  • End date
    Nov 24, 2025
  • participants needed
  • sponsor
    University of Florida
Updated on 24 May 2022


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.

Condition Smoking
Treatment Placebo, Kava
Clinical Study IdentifierNCT05081882
SponsorUniversity of Florida
Last Modified on24 May 2022


Yes No Not Sure

Inclusion Criteria

adults aged 21 years or above
self-reported smoking at least 10 cigarette/day for the past year with no intention to quit
expired carbon monoxide level of more than 8 ppm at recruitment
willingness to participate in the proposed study
access to a functional telephone
expected presence in the study's geographical area for the next 4 months
not currently enrolled in any smoking cessation programs
female subjects of childbearing potential will be required to practice acceptable methods of birth control (the acceptable methods of birth control include birth control pills, Birth Control Shot, Birth Control Implant, Intrauterine Device [IUD], Diaphragm, and cervical cap)

Exclusion Criteria

diagnosed with cancer (other than non-melanoma skin cancer)
diagnosed with liver dysfunction or with previous liver diseases
levels of alanine transaminase, aspartate transaminase, alkaline phosphatase, or total bilirubin over limit of normal range at prescreen
inability to refrain from acetaminophen, alcohol (no more than one drink daily via self-report), or other potentially hepatotoxic substances
use any other non-cigarette nicotine containing products such as smokeless tobacco, cigar or e-cigarettes
are pregnant or nursing (lactating) or of childbearing age planning to become pregnant or unwilling to use adequate contraception during the study
participant answered "Yes" to any of the ASQ questions 1 through 4, or refuses to answer
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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