A Phase 1 interventional study of Kava in Kava on the Metabolism of Nicotine and NNK, sponsored by University of Florida. Withdrawn. Open to participants aged 21 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by University of Florida · Phase 1, Interventional, and Supportive care
Tobacco smoking is the leading cause of head and neck cancer in the United States. Smoking cessation remains a challenge for many head/neck cancer survivors, indicating a need for development of more effective smoking cessation interventions. Kava's properties as a proven anxiolytic and carcinogen detoxifier warrant an investigation of its efficacy as an innovative smoking cessation aid. Kava may also influence carcinogen (NNK specifically) metabolism to help reduce carcinogenesis risk.
Tobacco smoking is the leading cause of head and neck cancer in the United States and a significant portion of head/neck cancer survivors continue to smoke even though smoking negatively impacts their clinical outcomes and increases chance of recurrence. Two tobacco chemicals, NNK and nicotine, are respectively responsible for the increased recurrence risk and tobacco addiction. Kava s properties as a proven anxiolytic and a potential carcinogen detoxifier warrant an investigation of its effects on the metabolism of these two tobacco chemicals among head/neck cancer survivors who continue to smoke. The results will identifying surrogate biomarkers and provide information regarding kava s potential as a future intervention to both promote smoking cessation and reduce carcinogenesis risk.
Primary Objective:
To explore the feasibility of recruitment of participants, adherence rate, acceptability of treatment and completion rate with 14 day dietary supplement kava treatment in head and neck cancer patients who continue to smoke.
To evaluate distribution of change in nicotine and NNK metabolism after 14 day kava treatment.
Exploratory Objective:
To evaluate distribution of change in mood after 14 day kava treatment. To evaluate prevalence of pain and pain medication use and distribution of change in pain and pain medication consumption after 14 day kava treatment.
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.
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Individuals eligible for study participation must meet the following criteria:
WOCBP include any woman who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or who is not post-menopausal. Post-menopause is defined as:
Exclusion Criteria:
Subjects with any of the following will not be eligible for study participation:
This is a single-arm pre- and post- Phase 0/1 study with one primary goal to explore the feasibility of recruitment of participants, adherence rate, acceptability of treatment and completion rate with 14 day dietary supplement kava treatment in head and neck cancer patients who continue to smoke. The other primary goal is to evaluate distribution of change in nicotine and NNK metabolism after 14 day kava treatment..
Drug: Kava
Kava: 75 mg three times daily (3 capsules)
Total NNAL
Total NNAL (the creatinine-normalized sum of NNAL, NNAL-N-gluc, and NNAL-O-gluc) will be calculated via urinary analysis at the screening visit and the final study visit to determine kava's effect on the pharmacokinetics and metabolism of carcinogens \[NNK: 4-(methylnitrosamino)-1-3(pyridyl)-1-butanone\].
Time frame: Two weeks
The ratio of total NNAL-gluc to NNAL
The ratio of total NNAL-gluc to NNAL will be calculated via urinary analysis at the screening visit and the final study visit to determine kava's effect on the pharmacokinetics and metabolism of carcinogens \[NNK: 4-(methylnitrosamino)-1-3(pyridyl)-1-butanone\].
Time frame: Two weeks
The urinary DNA adducts of 3-mA upon TNE correction
The urinary DNA adducts of 3-mA upon TNE correction will be calculated via urinary analysis at the screening visit and the final study visit to determine kava's effect on the pharmacokinetics and metabolism of carcinogens \[NNK: 4-(methylnitrosamino)-1-3(pyridyl)-1-butanone\].
Time frame: Two weeks
The ratio of total NNAL to TNE
The ratio of total NNAL to TNE (the creatinine-normalized sum of total nicotine, total cotinine, total 3-hydroxycotinine, and nicotine N-oxide) will be calculated via urinary analysis at the screening visit and the final study visit to determine kava's effect on the pharmacokinetics and metabolism of carcinogens \[NNK: 4-(methylnitrosamino)-1-3(pyridyl)-1-butanone\].
Time frame: Two weeks
The DNA adducts in the buccal cells from oral swab
The DNA adducts in the buccal cells will be calculated via oral swab at the screening visit and the final study visit to determine kava's effect on the pharmacokinetics and metabolism of carcinogens \[NNK: 4-(methylnitrosamino)-1-3(pyridyl)-1-butanone\].
Time frame: Two weeks
Positive and Negative Affect Scale (PANAS)
The efficacy of the dietary supplement kava to positively affect mood will be evaluated via questionnaire. The PANAS scale consists of 20 words that describe different feelings and emotions that can be rated as: 1) Very slightly or not at all 2) A little 3) Moderately 4) Quite a bit 5) Extremely. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
WHO Quality of Life BREF (WHOQOL-BREF)
Kava's effect on pain and pain medicine consumption will be evaluated via questionnaire. The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
Brief Pain Inventory Questionnaire
Kava's effect on pain and pain medicine consumption will be evaluated via questionnaire. The purpose of the BPI is to assess the severity of pain and the impact of pain on daily functions, and focuses on patients with pain from chronic diseases or conditions such as cancer, osteoarthritis and low back pain, or with pain from acute conditions such as postoperative pain. It assesses areas of pain severity, impact of pain on daily function, location of pain, pain medications and amount of pain relief in the past 24 hours or the past week. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
Minnesota Nicotine Withdrawal Scale (MNWS)
The efficacy of the dietary supplement kava to reduce tobacco use will be evaluated via questionnaire. The MNWS is used to assess withdrawal symptoms. The nine items of the MNWS included the following: urge to smoke (craving); depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; and difficulty staying asleep. Each item was rated by a subject on an ordinal scale from 0 (not at all) to 4 (extreme). This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
Fagerstrom Test Nicotine Dependence (FTND)
The efficacy of the dietary supplement kava to reduce tobacco use will be evaluated via questionnaire. The FTND is a standard instrument for assessing the intensity of physical addiction to nicotine. This test was designed to provide an ordinal measure of nicotine dependence related to cigarette smoking. It contains six items that evaluate the quantity of cigarette consumption, the compulsion to use, and dependence. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
Brief Questionnaire of Smoking Urges (QSU-Brief)
The efficacy of the dietary supplement kava to reduce tobacco use will be evaluated via questionnaire. The QSU-Brief questionnaire consists of 10 items comprising four putative features of craving including anticipation of relief of nicotine withdrawal, anticipation of positive outcomes of smoking, desire to smoke, and intention to smoke. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
Modified Cigarette Evaluation Scale (mCES)
The efficacy of the dietary supplement kava to reduce tobacco use will be evaluated via questionnaire. The mCES contains 12 items rated on a 0-6 point Likert scale from 'not at all' to 'extremely'. The mCES is comprised of several subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
Cancer Patient Tobacco Use Questionnaire (C-TUQ)
The efficacy of the dietary supplement kava to reduce tobacco use will be evaluated via questionnaire. The C-TUQ is a 22-item self-report survey designed to capture information about tobacco use by cancer patients and cancer survivors. The C-TUQ survey tool is divided into five domains: 1) Basic Tobacco Use Information 2) Cigarette Smoking in Relation to Cancer Diagnosis and Treatment 3) Smoking Cessation, Cessation Products, and Assistance Methods 4) Use of Other Products 5) Second-Hand Smoke Exposure. This questionnaire will be completed at the initial study visit and at the final study visit.
Time frame: Two weeks
No study locations are listed for this record.
Plan to share: No
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