Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava

Trials

Study Protocol

Zhiguang Huo¹  John Malaty²  Ramzi G. Salloum³  Melissa Bou Malham³  Anna Maria Abi Nehme³  Chengguo Xing⁴  Breanne Freeman⁴  Roberto Firpi-Morrel⁵ 

[1] Department of Biostatistics, College of Public Health and Health Professions and College of Medicine, University of Florida, Gainesville, FL, USA;Department of Community Health and Family Medicine, College of Medicine, University of Florida, Gainesville, FL, USA;Department of Health Outcomes and Biomedical Informatics, College of Medicine, University of Florida, Gainesville, FL, USA;Department of Medicinal Chemistry, College of Pharmacy, University of Florida, Gainesville, FL, USA;Division of Gastroenterology, College of Medicine, University of Florida, Gainesville, FL, USA;

关键词: Randomized controlled trial;    Tobacco dependence;    Smoking cessation;    Kava;   

DOI  :  10.1186/s13063-023-07081-x

 received in 2022-11-07, accepted in 2023-01-06,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundTobacco use is the leading cause of many preventable diseases, resulting in premature death or disease. Given that the majority of adult who smoke want to stop, this health burden could be significantly reduced if the success rate of tobacco cessation can be improved. In addition, most adults planning to quit were interested in trying complementary approaches to facilitating tobacco cessation, which is currently lacking. 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 goal of this project 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 smokers.MethodsA randomized controlled trial will enroll 80 adults who currently smoke at least 10 cigarettes daily and randomize 1:1 into the placebo and AB-free kava arms, being exposed for 4 weeks, with a total of six visits (weeks 0, 1, 2, 4, 8, and 12) to evaluate the compliance and potential issues of AB-free kava use among the participants, explore the potential effect of the AB-free kava intervention on tobacco dependence, tobacco use, and lung carcinogenesis biomarkers. Participants will be enrolled during their primary care clinic visit.DiscussionPrimary care settings play a critical role in tobacco-related disease screening, counseling, and early intervention, as the majority of adults who smoke visit their physicians annually. Building upon our promising pilot human trial results in conjunction with ample compelling lab animal results, and consistent with evidence of kava’s benefits from epidemiological data, this trial will evaluate the compliance of AB-free kava among adults who currently smoke with no intention to quit. The other exploratory aims include (1) whether AB-free kava intervention can reduce tobacco use and tobacco dependence; (2) whether AB-free kava use suppresses tobacco-induced carcinogenesis; and (3) the potential of the mechanism-based noninvasive biomarkers in precision AB-free kava intervention. The positive results from this study are expected to provide a great opportunity to effectively reduce smoking rates and tobacco-related diseases.Trial registrationClinicalTrials.gov with the identifier: NCT05081882. Registered on October 18, 2021.

【 授权许可】

CC BY   
© The Author(s) 2023

【 图 表 】

Fig. 5

Fig. 1

40798_2022_490_Article_IEq87.gif

13690_2022_1010_Article_IEq14.gif

13690_2022_1010_Article_IEq8.gif