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Kava drink tested to help smokers cut down and lower cancer risk

NCT ID NCT05081882

Disease control Sponsor: University of Florida Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether a daily kava drink can help active smokers who don't plan to quit reduce their smoking and lower their risk of lung cancer. Twenty adult smokers will take kava daily for several months. Researchers will check how well participants stick with the regimen, and whether it leads to fewer cigarettes smoked and less cancer-related damage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

19 people

The number who actually took part.

Started

Jun 2022

Finished

Jun 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 99 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

nicotine dependence Smoking Smoking Cessation lung cancer prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Smoking

Contacts and locations

Locations

  • University of Florida

    Gainesville, Florida, 32608, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.