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Active, Not Recruiting

NCT Number: NCT05081882

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Smoking Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Cessation Substance-Related Disorders Tobacco Use Disorder

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Florida

Gainesville, Florida, 32608, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Kava

Drug

Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.

Placebo

Drug

Participants on this arm will take one placebo capsule orally three times daily for 28 days.

Primary outcomes

  1. Subject Compliance with Intervention

    Time frame: 4 weeks

    Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses

  2. Subject Compliance with Intervention

    Time frame: 4 weeks

    Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine

Secondary outcomes

  1. Tobacco cessation

    Time frame: 12 weeks

    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked

  2. Tobacco cessation

    Time frame: 12 weeks

    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)

  3. Tobacco cessation

    Time frame: 12 weeks

    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)

  4. Tobacco cessation

    Time frame: 12 weeks

    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)

  5. Tobacco cessation

    Time frame: 12 weeks

    Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Florida Department of Health

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Oct 18, 2021
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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