Investigation of Kava Effects on the Metabolism of the Tobacco-specific Carcinogen 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK) in Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
研究概览
简要总结
This is a non-therapeutic, single-arm pilot clinical trial in adult healthy smokers to assess whether kava can alter NNK metabolism in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult ≥ 18 years
- •Current smoker of ≥ 5 cigarettes daily, determined by self-report
- •Adequate liver and kidney function, defined as:
- •Bilirubin, alkaline phosphatase, ALT, and AST within normal limits
- •Creatinine <1.2
- •Adequate hemoglobin, defined as a hemoglobin ≥12 mg/dL for men and ≥11 for women.
- •Ability and willingness to abstain from all medication and dietary supplements for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration. Topical medications and inhaled medications that do not contain steroids are permitted.
- •Ability and willingness to completely abstain from alcohol consumption for 3 days prior to kava administration, continuing until a minimum of 7 days after kava administration
- •Ability to understand the investigational nature of the study and provide informed consent
- •Willingness to take kava supplement as instructed
排除标准
- •Known hepatobiliary disease or impairment
- •History of gastric bypass surgery, gastric banding, bowel resection, malabsorption syndromes such as celiac sprue or pancreatic insufficiency, or other conditions that may affect the absorption of kava
- •Chronic medication use that cannot be safely stopped
- •Use of tobacco products other than cigarettes (i.e. snuff, snuz, smokeless tobacco, cigars, pipes)
- •Major or chronic medical medical disease, including heart disease, poorly controlled diabetes, etc., to be adjudicated by the principal investigator
- •Women who are pregnant, intend to become pregnant within 3 months of the study period, or who are breastfeeding
- •Current or recent (within 12 months) problems with drug use or alcohol dependence by self-report
- •Antibiotic use within 2 months of study enrollment by self-report
- •Alcohol dependence, abuse, or history of dependence/abuse by self-report
研究组 & 干预措施
Kava Supplement
See intervention description.
干预措施: Kava (Dietary Supplement)
结局指标
主要结局
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
时间窗: Day 7
Compare urinary level of total NNAL before and after short-term kava administration
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
时间窗: Day 5
Compare urinary level of total NNAL before and after short-term kava administration
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
时间窗: Day 1
Compare urinary level of total NNAL before and after short-term kava administration
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
时间窗: Day 2
Compare urinary level of total NNAL before and after short-term kava administration
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
时间窗: Day 4
Compare urinary level of total NNAL before and after short-term kava administration
Urinary level (nmol/mL) of total NNAL before and after short-term kava administration
时间窗: Day 6
Compare urinary level of total NNAL before and after short-term kava administration
次要结局
- Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration(Day 7)
- O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration(Day 7)
- Percentage of subjects experiencing any particular adverse event(Day 7)
- Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration(Day 1)
- Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration(Day 2)
- Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration(Day 4)
- Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration(Day 5)
- Ratio of urinary NNAL-gluc (nmol/mL) and free NNAL (nmol/mL) before and after short-term kava administration(Day 6)
- Percentage of subjects experiencing any particular adverse event(Day 4)
- O6-mG adducts level (fmol) in peripheral blood cells before and after short-term kava administration(Day 4)