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

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.

Timeline

Start

2022-06-09

Primary completion

2026-12

Completion

2026-12

Publications

• Freeman B, Bian T, Xu G, Wheeler M, Fujioka N, Malaty J, Orlando FA, Braithwaite D, Salloum RG, Bruijnzeel AW, Zhang W, Xing C. Assessing the physiological relevance of the bioactivation of tobacco-specific carcinogen NNK and its metabolite NNAL: quantitative analyses of hydrolysis products from their protein adducts under different carcinogen exposure conditions. Carcinogenesis. 2026 Apr 9;47(2):bgag031. doi: 10.1093/carcin/bgag031.
• Xing C, Malaty J, Malham MB, Nehme AMA, Freeman B, Huo Z, Firpi-Morrel R, Salloum RG. Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava. Trials. 2023 Jan 18;24(1):36. doi: 10.1186/s13063-023-07081-x.

Drugs

Indications

No indication recorded.