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

StatusTerminated
PhasePhase 2
Started2022-06-09
View on ClinicalTrials.gov ↗

Amendment history

2026-08-13
Completed→Terminated Study Status, Outcome Measures, Outcome Measures (Results) v21
Trial terminated: slow accrual
Primary endpoint(s) modified2 to 1 entries
WasSubject Compliance with Intervention, Subject Compliance with Intervention
NowUrinary Total Nicotine Equivalents
Primary completion confirmed: June 2025 (last estimated December 2026)
Results posted: 2026-09-03
Trial statusCompleted→Terminated
Secondary endpointsdetails revised at 1 of 8 entries
2026-06-26
Active, Not Recruiting→Completed Study Status, Study Design, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v20
Trial statusActive, Not Recruiting→Completed
Primary completion dateestimated 2026-12→confirmed 2025-06-30
Completion dateestimated 2026-12→confirmed 2025-06-30
Enrollment target20→19
Secondary endpoints5 to 8 entries
TobaccoReinforcing cessationEffects of Smoking TobaccoParticipant cessationReported Number of Cigarettes Smoked Weekly TobaccoParticipant cessationUrge to Smoke TobaccoNicotine cessationDependency TobaccoPerceived cessationStress Severity of Insomnia Compliance Score Percentage Participant Compliance Status
Primary endpoints2 entries, revised
SubjectEffect Complianceof withKava Interventionand Time on Urinary Total Nicotine Equivalents SubjectEffect Complianceof withKava Interventionand Time on Urinary Total Nicotine Equivalents
2026-02-16
Terminated→Active, Not Recruiting Study Status v19
Trial statusTerminated→Active, Not Recruiting
Reason stoppedslow accrual→not stated
Primary completion date2025-06-30→2026-12
Completion date2025-06-30→2026-12
2025-09-22
Active, Not Recruiting→Terminated Study Status v18
Trial statusActive, Not Recruiting→Terminated
Reason stoppednot stated→slow accrual
Primary completion dateestimated 2025-09→confirmed 2025-06-30
Completion dateestimated 2025-09→confirmed 2025-06-30
2025-07-11
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v17
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-11→2025-09
Completion date2026-11→2025-09
Enrollment targetestimated 80→confirmed 20
Study sitesdetails revised at 1 of 1 site
Show 16 earlier versions
2025-06-12
Suspended→Recruiting Study Status, Contacts/Locations v16
Trial statusSuspended→Recruiting
Reason stoppedsuspension by internal data integrity and safety committee→not stated
Study sitesdetails revised at 1 of 1 site
2025-04-24
Study Status, Eligibility v15
Eligibility criteria-14 characters
[...] 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 s [...] ths not currently enrolled in any smoking cessation programs per self-report female subjects of childbearing potential will be required [...] ice [IUD], Diaphragm, and cervical cap) Exclusion Criteria: diagnosedhistory withof active cancer (other than non-melanoma skin cancer) within the past 2 years dia [...] [...]
2025-02-05
Recruiting→Suspended Study Status, Contacts/Locations v14
Trial statusRecruiting→Suspended
Reason stoppednot stated→suspension by internal data integrity and safety committee
Study sitesdetails revised at 1 of 1 site
2025-01-28
Study Status, Study Design v13
Re-verified, no change to tracked fields
2024-09-06
Study Status, Eligibility v12
Primary completion date2024-11→2025-11
Completion date2025-11→2026-11
Eligibility criteria+3 characters
Inclusion Criteria: adults aged 21 years or above self-reported smoking at least 105 cigarettecigarettes/day for the past year with no intention to quit expired car [...] o question 4 but the most recent suicide attempt took place >>12 months from screening visit then subject is still eligible.
2024-03-28
Suspended→Recruiting Study Status, Eligibility, Contacts/Locations v11
Trial statusSuspended→Recruiting
Reason stoppedstudy suspended by internal data integrity and safety committee→not stated
Start date2022-05-31→2022-06-09
Eligibility criteria+151 characters
[...] o any of the ASQ questions 1 through 4, or refuses to answer. If subject answers 'Yes' to question 4 but the most recent suicide attempt took place >12 months from screening visit then subject is still eligible.
Study sitesdetails revised at 1 of 1 site
2023-10-16
Recruiting→Suspended Study Status, Contacts/Locations v10
Trial statusRecruiting→Suspended
Reason stoppednot stated→study suspended by internal data integrity and safety committee
Study sitesdetails revised at 1 of 1 site
2023-02-22
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 1 site
2023-01-17
Suspended→Recruiting Study Status, Contacts/Locations v8
Trial statusSuspended→Recruiting
Reason stoppedpending protocol revision→not stated
Study sitesdetails revised at 1 of 1 site
2022-11-16
Recruiting→Suspended Study Status, Contacts/Locations v7
Trial statusRecruiting→Suspended
Reason stoppednot stated→pending protocol revision
Study sitesdetails revised at 1 of 1 site
2022-07-05
Study Status v6
Start dateestimated 2022-06→confirmed 2022-05-31
2022-05-17
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v5
Trial statusNot Yet Recruiting→Recruiting
Start date2022-04→2022-06
Study sites0→1
2022-03-15
Study Status v4
Start date2022-03→2022-04
2022-02-16
Study Status, Eligibility, Contacts/Locations v3
Primary completion date2023-11→2024-11
Completion date2024-11→2025-11
Start date2022-01→2022-03
Eligibility criteria+89 characters
[...] or unwilling to use adequate contraception during the study participant answered "Yes" to any of the ASQ questions 1 through 4, or refuses to answer
2021-12-21
Study Status, Eligibility, Contacts/Locations v2
Start date2021-12→2022-01
Eligibility criteria-20 characters
[...] om acetaminophen, alcohol (no more than one drink daily via both self-report and blood test), or other potentially hepatotoxic substances use any other [...]
2021-11-15
Study Status v1
Start date2021-11→2021-12
2021-10-05
Original filing
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.
Trial Details
NCT Number NCT05081882
Lead Sponsor University of Florida
Collaborators: Florida Department of Health
Conditions Smoking
Enrollment 19 participants
Start Date 2022-06-09
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-09-03