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

Launched by UNIVERSITY OF FLORIDA · Oct 5, 2021

Keywords

ClinConnect Summary

This clinical trial is studying a possible new way to help people who smoke cigarettes and are not ready to quit. Researchers want to see if a kava-based treatment can help reduce smoking habits and lower the risk of developing lung cancer, which is a major health problem in Florida. This study is important because many adults in Florida continue to smoke despite the known risks, and finding effective support for them is urgently needed.

To participate in the trial, individuals must be at least 21 years old, have been smoking at least five cigarettes a day for the past year, and must not be planning to quit smoking during the study. Participants should also be able to commit to the study for four months and will need to have a phone to stay in contact with the research team. Throughout the study, participants will take kava daily and report on their smoking habits and any changes they experience. It's important to note that certain health conditions and lifestyle factors may exclude some individuals from participating, so eligibility will be carefully assessed.

Gender

ALL

Eligibility criteria

• 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' to question 4 but the most recent suicide attempt took place more than12 months from screening visit then subject is still eligible.