Clinical trial NCT05081882: Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava
Official title: Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Smoking
Keywords: tobacco dependence
smoking cessation
kava
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Florida Department of Health
First posted: 2021-10-18
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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.

Primary outcomes:
measure: Subject Compliance with Intervention
timeFrame: 4 weeks
measure: Subject Compliance with Intervention
timeFrame: 4 weeks
Secondary outcomes:
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
measure: Tobacco cessation
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Ramzi Salloum, PhD
role: PRINCIPAL_INVESTIGATOR
References: