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

Study Overview
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Brief Summary
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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.

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

Conditions
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Smoking

Intervention / Treatment
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* Drug: Kava
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kava Intervention<br> | Drug: Kava<br>* Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.<br>|
| Placebo Comparator: Placebo Control<br> | Drug: Placebo<br>* Participants on this arm will take one placebo capsule orally three times daily for 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject Compliance with Intervention | Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses | 4 weeks | 
| Subject Compliance with Intervention | Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND) | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ) | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief) | 12 weeks | 
| Tobacco cessation | Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tobacco dependence, smoking cessation, kava