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Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava - Trial NCT05081882

Access comprehensive clinical trial information for NCT05081882 through Pure Global AI's free database. This Phase 2 trial is sponsored by University of Florida and is currently Not yet recruiting. The study focuses on Smoking. Target enrollment is 80 participants.

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NCT05081882
Phase 2
Not yet recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05081882
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Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava

Study Focus

Smoking

Kava

Interventional

drug

Sponsor & Location

University of Florida

Timeline & Enrollment

Phase 2

Apr 01, 2022

Nov 01, 2025

80 participants

Primary Outcome

Subject Compliance with Intervention,Subject Compliance with Intervention

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.

ICD-10 Classifications

Tobacco use
Exposure to tobacco smoke
Toxic effect: Tobacco and nicotine
Mental and behavioural disorders due to use of tobacco : harmful use
Drug use

Data Source

ClinicalTrials.gov

NCT05081882

Non-Device Trial