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

August 13, 2026 updated by: University of Florida

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
19

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Control
Drug: Placebo
Participants on this arm will take one placebo capsule orally three times daily for 28 days.
Experimental: Kava Intervention
Drug: Kava
Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Urinary Total Nicotine Equivalents
Time Frame: at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
Measure urinary total nicotine equivalents (TNE). TNE is the sum of nicotine and its metabolites in a participant's urine. TNE was measured at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Reinforcing Effects of Smoking
Time Frame: At baseline (Day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after starting treatment)
Determine if participants experience reinforcing effects of smoking using the Modified Cigarette Evaluation Questionnaire. Subjects respond with a whole number numerical value from 1 to 7 for each item. The item responses are used to determine 5 scores: smoking satisfaction, psychological reward, aversion, enjoyment of respiratory tract sensations and craving reduction. Each score is either the response to a single item (for the enjoyment of respiratory tract sensations and craving reduction scores) or is calculated as the mean of multiple individual item responses (for the smoking satisfaction, psychological reward, and aversion scores). Possible values for each score range from a minimum of 1 and a maximum of 7. A higher value is worse for the smoking satisfaction, psychological reward and craving reduction scores. A lower value is worse for the aversion score. A higher score for the respiratory tract sensations score means greater enjoyment of respiratory tract sensations.
At baseline (Day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after starting treatment)
Participant Reported Number of Cigarettes Smoked Weekly
Time Frame: At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Determine the participant reported number of cigarettes smoked weekly. The number of cigarettes smoked was measured by having participants document how many cigarettes they smoked in the past week on a calendar. Participants completed this at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Participant Urge to Smoke
Time Frame: At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Measure participant urge to smoke using the Brief Questionnaire on Smoking Urges (QSU-Brief). The QSU-Brief is a 10-item scale, assessing the features of craving, including the anticipation of relief of nicotine withdrawal, anticipation of positive outcomes of smoking, desire to smoke, and intention to smoke. Participants respond with a score from 1 (best) to 7 (worst) for each item. Possible total scores range from 10 to 70, with a higher score meaning a greater urge to smoke. Participants completed the QSU-Brief at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Nicotine Dependency
Time Frame: At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Measure participant nicotine dependency using the Fagerström Test for Nicotine Dependence (FTND). The FTND is a 6-item scale measuring the level of nicotine dependency or addiction. It assesses how soon tobacco use begins each day, which cigarettes during the day a person could do without, how smokers cope in places where they cannot smoke, and how frequently and how deeply they smoke. Responses for each item are given either 0 points or 1 point for 4 items and 0-3 points for 2 items, with more points meaning a greater nicotine dependency. Possible total scores range from 0 to 10 points, with a higher score meaning a greater nicotine dependency. Participants completed the FTND at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Perceived Stress
Time Frame: At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Measure participant perceived stress using the Perceived Stress Scale (PSS). The PSS is a 10-item scale measuring the perception of stress. It is a measure of the degree to which situations in one's life are appraised as stressful. The scale also includes a number of direct queries about current levels of experienced stress. Participants respond to each item with a score of 0 ("never") to 4 ("very often"). A higher score is worse for the 6 items assessing negative outcomes, such as how often participants felt nervous and stressed and a lower score is worse for the 4 items assessing positive outcomes, such as how often participants felt on top of things. Possible total scores range from 0 to 40, with a higher score meaning higher perceived stress. Participants completed the PSS at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Severity of Insomnia
Time Frame: At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Measure severity of participant insomnia using the Insomnia Severity Scale. The Insomnia Severity Scale is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia. Participants respond to each item with a score of 0 (best) to 4 (worst). Possible total scores range from 0 to 28, with a higher score meaning more severe insomnia. Participants completed the Insomnia Severity Scale at baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment.
At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment)
Compliance Score Percentage
Time Frame: At end of treatment (28 days after starting treatment)
Evaluate subject compliance with the kava intervention, as measured by the compliance score percentage. The compliance score percentage was calculated by dividing the total number of kava or placebo capsules actually consumed across all visits by the total number of kava or placebo capsules expected to be consumed across all visits and multiplying the result by 100.
At end of treatment (28 days after starting treatment)
Participant Compliance Status
Time Frame: At end of treatment (28 days after starting treatment)
Determine participant compliance status, defined as whether the number of kava or placebo capsules expected to be returned matched the number of kava or placebo capsules actually returned by a participant across all visits, with "Yes" indicating a match and "No" indicating a mismatch.
At end of treatment (28 days after starting treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Florida

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Florida Department of Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ramzi Salloum, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 5, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Kava
  • OCR40933 (Other Identifier: University of Florida)
  • IRB202101885 (Other Identifier: University of Florida IRB-01)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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