A Phase 2 interventional study of Placebo and AB-free kava in Smoking, sponsored by University of Florida. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-27.
Sponsored by University of Florida · Phase 2, Interventional, and Prevention
This study will evaluate the compliance with a daily kava regimen among active smokers who have an intention to quit smoking. This study will also investigate whether kava use can facilitate tobacco cessation, reduce stress, and improve sleep.
268 studies on the registry are indexed under Smoking; 136 are open to participants now.
This study's planned enrollment of 76 is below the median of 120 across 211 interventional studies indexed under Smoking.
Browse Smoking studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: AB-free kava
Drug: Placebo
Participants on this arm will take one placebo capsule orally three times daily for 4 weeks.
Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 4 weeks.
Subject Compliance with Intervention
Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
Time frame: 4 weeks
Subject Compliance with Intervention
Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine by urine testing
Time frame: 4 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked
Time frame: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)
Time frame: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)
Time frame: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)
Time frame: 12 weeks
Tobacco cessation
Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents
Time frame: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by the Perceived Stress Scale (PSS). The Perceived Stress Scale consists of 10 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 40 and the minimum score is 0. A higher score indicates greater perceived stress.
Time frame: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by plasma PRKACA
Time frame: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by plasma cortisol
Time frame: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by urinary TCE
Time frame: 12 weeks
Effect on stress
Examine whether kava has the potential to reduce stress, as measured by total cortisol equivalents
Time frame: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by the Insomnia Severity Scale. The Insomnia Severity Scale instrument consists of 7 items that are each scored on a scale of 0-4. The maximum possible score for this instrument is 28 and the minimum score is 0. A higher score indicates more severe insomnia.
Time frame: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by the Pittsburgh Sleep Quality Index (PSQI)
Time frame: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by urinary 6-hydroxymelatonin
Time frame: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by urinary N-acetyl serotonin
Time frame: 12 weeks
Effect on sleep
Examine whether kava has the potential to improve sleep, as measured by urinary NAS
Time frame: 12 weeks
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