Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava
Abstract Background Tobacco 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...
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| Format: | Article |
| Language: | English |
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BMC
2023-01-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07081-x |
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| author | Chengguo Xing John Malaty Melissa Bou Malham Anna Maria Abi Nehme Breanne Freeman Zhiguang Huo Roberto Firpi-Morrel Ramzi G. Salloum |
| author_facet | Chengguo Xing John Malaty Melissa Bou Malham Anna Maria Abi Nehme Breanne Freeman Zhiguang Huo Roberto Firpi-Morrel Ramzi G. Salloum |
| author_sort | Chengguo Xing |
| collection | DOAJ |
| description | Abstract Background Tobacco 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. Methods A 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. Discussion Primary 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 registration ClinicalTrials.gov with the identifier: NCT05081882. Registered on October 18, 2021. |
| first_indexed | 2024-04-10T20:59:45Z |
| format | Article |
| id | doaj.art-45978af9b1e14db8a4ea567abd888510 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-10T20:59:45Z |
| publishDate | 2023-01-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-45978af9b1e14db8a4ea567abd8885102023-01-22T12:24:24ZengBMCTrials1745-62152023-01-0124111410.1186/s13063-023-07081-xReducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kavaChengguo Xing0John Malaty1Melissa Bou Malham2Anna Maria Abi Nehme3Breanne Freeman4Zhiguang Huo5Roberto Firpi-Morrel6Ramzi G. Salloum7Department of Medicinal Chemistry, College of Pharmacy, University of FloridaDepartment of Community Health and Family Medicine, College of Medicine, University of FloridaDepartment of Health Outcomes and Biomedical Informatics, College of Medicine, University of FloridaDepartment of Health Outcomes and Biomedical Informatics, College of Medicine, University of FloridaDepartment of Medicinal Chemistry, College of Pharmacy, University of FloridaDepartment of Biostatistics, College of Public Health and Health Professions and College of Medicine, University of FloridaDivision of Gastroenterology, College of Medicine, University of FloridaDepartment of Health Outcomes and Biomedical Informatics, College of Medicine, University of FloridaAbstract Background Tobacco 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. Methods A 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. Discussion Primary 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 registration ClinicalTrials.gov with the identifier: NCT05081882. Registered on October 18, 2021.https://doi.org/10.1186/s13063-023-07081-xRandomized controlled trialTobacco dependenceSmoking cessationKava |
| spellingShingle | Chengguo Xing John Malaty Melissa Bou Malham Anna Maria Abi Nehme Breanne Freeman Zhiguang Huo Roberto Firpi-Morrel Ramzi G. Salloum Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava Trials Randomized controlled trial Tobacco dependence Smoking cessation Kava |
| title | Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava |
| title_full | Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava |
| title_fullStr | Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava |
| title_full_unstemmed | Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava |
| title_short | Reducing tobacco-associated lung cancer risk: a study protocol for a randomized clinical trial of AB-free kava |
| title_sort | reducing tobacco associated lung cancer risk a study protocol for a randomized clinical trial of ab free kava |
| topic | Randomized controlled trial Tobacco dependence Smoking cessation Kava |
| url | https://doi.org/10.1186/s13063-023-07081-x |
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