Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava (NCT05081882) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava
United States20 participantsStarted 2022-06-09
Plain-language summary
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.
Who can participate
Age range
21 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* adults aged 21 years or above
* self-reported smoking at least 5 cigarettes/day for the past year with no intention to quit at time of screening visit
* expired carbon monoxide level of more than 8 ppm at recruitment
* willingness to participate in the proposed study, as indicated by signed informed consent
* 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 per self-report
* 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:
* history of active cancer (other than non-melanoma skin cancer) within the past 2 years
* 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)
* 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 3, or refuses to answer all of the questions. If subject answers 'Yes' t…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.