Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Urinary Total Nicotine Equivalents
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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.
研究组 & 干预措施
Placebo Control
干预措施: Placebo (Drug)
Kava Intervention
干预措施: Kava (Drug)
结局指标
主要结局
Urinary Total Nicotine Equivalents
时间窗: at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
Measure urinary total nicotine equivalents (TNE). TNE is the sum of nicotine and its metabolites in a participant's urine. TNE was measured at baseline (on Day 1 of treatment), after 1 and 2 weeks on treatment, at the end of treatment, at 4 weeks after end of treatment and at 8 weeks after end of treatment.
Subject Compliance with Intervention
时间窗: 4 weeks
Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses
次要结局
- Reinforcing Effects of Smoking(At baseline (Day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after starting treatment))
- Perceived Stress(At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment))
- Participant Reported Number of Cigarettes Smoked Weekly(At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment))
- Participant Urge to Smoke(At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment))
- Nicotine Dependency(At baseline (day 1 of treatment), at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment))
- Severity of Insomnia(At baseline (day 1) of treatment, at 1 week and 2 weeks after beginning treatment, and at the end of treatment (28 days after beginning treatment))
- Compliance Score Percentage(At end of treatment (28 days after starting treatment))
- Participant Compliance Status(At end of treatment (28 days after starting treatment))
- Tobacco cessation(12 weeks)