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

University of Florida

Status and phase

Suspended

Phase 2

Conditions

Smoking

Treatments

Drug: Kava

Drug: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT05081882

Kava

OCR40933 (Other Identifier)

IRB202101885 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

21 to 99 years old

Volunteers

No Healthy Volunteers

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.