NCT05855343已完成不适用
Exploratory Study of Switching From Combustible Cigarettes to the BIDI E-cigarette
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 3
- 主要终点
- Degree of Smoking Reduction
研究概览
简要总结
The aim of this study is to shed light on the importance of nicotine pharmacokinetics in switching to a reduced-harm product by fully matching the nicotine pharmacokinetics of smokers' usual brands of cigarettes.
The primary objective is to ascertain the degree of smoking reduction when smokers attempt to switch to an e-cigarette that matches peak nicotine concentrations of a cigarette.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has signed the ICF and is able to understand the information provided in the ICF.
- •Is 22 to 65 years of age (inclusive) at screening.
- •Smokes ≥ 10 commercially available CCs per day (no brand restrictions), for the last 12 months.
- •Expired air CO reading of at least 10 ppm as assessed at the screening session.
- •Interested in switching to an electronic cigarette.
- •Willing and able to comply with the requirements of the study.
- •Owns a smart phone with text message and data capabilities compatible with necessary surveys.
排除标准
- •Is unhealthy or cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason) as judged by the Investigator or designated medical staff based on all available assessments from the screening period (e.g., vital signs, physical examination, ECG, concomitant medications and medical history).
- •PHQ-9 score greater than 9, or a score greater than 0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") at screening.
- •Planned use of an FDA-approved smoking cessation product during the study.
- •High Blood Pressure (systolic >150 mm Hg, diastolic >95 mm Hg) at screening.
- •Body mass index (BMI) less than 15.0 kg/m2 or greater than 40.0 kg/m2 at screening.
- •Coronary heart disease, structural cardiac disease (including, but not limited to valvular heart disease or cardiac murmurs), cardiac dysrhythmias, syncope, cardiac chest pain, or history of heart attack or heart failure.
- •Has received psychotherapy or behavioral treatments within 30 days of screening, or during the study.
- •Taking antidepressants or psychoactive medications (e.g. antipsychotics, benzodiazepines, hypnotics).
- •Use of any of these products in the past 30 days:
- •Illegal drugs (or if the urine drug screen is positive for cocaine, THC, amphetamines, phencyclidine (PCP), or opiates without a medical prescription);
- •Experimental (investigational) drugs that are unknown to participant;
- •Chronic opiate use.
- •Use of smokeless tobacco (chewing tobacco, snuff), cigars (except for "Black & Mild" cigars or Cigarillos), pipes, hookah, e-cigarettes, nicotine replacement therapy or other smoking cessation treatments within 14 days of screening.
- •Pregnant or nursing (by self-report) or positive pregnancy test.
- •Enrollment is complete.
结局指标
主要结局
Degree of Smoking Reduction
时间窗: From Baseline to Week 12
Change in self-reported cigarettes smoked daily
次要结局
- Subjective response to an e-cigarette(From Baseline to Week 12)
研究者
研究点 (3)
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