Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 105
- 试验地点
- 2
- 主要终点
- Urinary NNAL Concentration
研究概览
简要总结
The overall goal of this project is to understand the likely health effects of cigarette smokers switching to a Standardized Research Electronic Cigarette (SREC) and to assess the role of nicotine delivery on switching and acceptability as well as markers of health outcomes.
Current smokers who meet all eligibility criteria will completely switch from their combustible (regular) cigarettes to an electronic cigarette (SREC) that either contains 58 mg/ml of nicotine or 0 mg/ml of nicotine in the liquid.
The investigators' hypothesis is that attempting to switch to a SREC will result in a reduction in markers of harms to health, as compared with the baseline (smoking) measures. The investigators also hypothesize that nicotine-containing SRECs will facilitate switching from smoking more efficiently than zero nicotine SRECs and will result in a significantly greater improvement in markers of health risk, but will result in higher ratings of dependence on the SREC (as compared to the zero nicotine SREC).
详细描述
This project is a prospective parallel-group randomized double-blind, placebo-controlled study in which 104 current smokers who are willing to completely switch from their regular cigarettes to an electronic cigarette (SREC) for 6 weeks will be randomly allocated to use a SREC containing either 58 or 0 mg/ml nicotine in the liquid.
Following randomization to their assigned study product, participants will be supported in their switching efforts with regular contacts both in person at the Penn State Milton S. Hershey Medical Center and over the phone. The main measures will be recorded at two in-person visits after the randomization (switching) visit: (a) 3 weeks after switching and (b) 6 weeks after switching. All participants will also be followed up at 10 weeks by phone to identify whether they have continued to use electronic cigarettes or regular cigarettes and to assess their motivation to change.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 to 70
- •Smoke ≥5 cigarettes per day for at least the past 12 months
- •Smoke regular, filtered cigarettes or machine-rolled cigarettes with a filter
- •Exhaled CO measurement ≥6 ppm at baseline visit
- •No serious quit attempt in prior month
- •Willing to completely cease cigarette consumption and switch to an e-cig
- •Willing and able to attend regular visits over a 7-week period
- •Able to read and write in English
- •Able to understand and consent to study procedures
排除标准
- •Unstable or significant medical condition such as COPD, kidney disease, or liver disease in the past 12 months
- •Severe immune system disorders
- •Women who are pregnant, trying to become pregnant, or nursing
- •Use of any non-cigarette nicotine delivery product in the past 7 days
- •Use of an e-cig for 5 or more days in the past 28 days or any use in the past 7 days
- •Uncontrolled mental illness or substance abuse or inpatient treatment for these conditions in the past 6 months
- •History of a seizure disorder or had a seizure in the past 12 months
- •Currently or have ever taken medications prescribed to prevent seizures (such as Carbamazepine or Phenobarbital). Using seizure medications for off-label use (indications other than treatment for seizures) will not be included as an exclusion, these will be assessed on a case-by-case basis.
- •History of difficulty providing or unwilling to provide blood samples (fainting, poor veins, anxiety, seizures)
- •Surgery requiring general anesthesia in the past 6 weeks
- •Use of marijuana or any illicit drug/prescription drugs for non-medical use daily/almost daily or weekly in the past 3 months per NIDA Quick Screen
- •Use of hand-rolled, roll your own cigarettes
- •Known allergy to propylene glycol or vegetable glycerin
- •Other member of household currently participating in the study
结局指标
主要结局
Urinary NNAL Concentration
时间窗: 6-week visit (post-treatment)
Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine
次要结局
- Pulmonary Function(6-week visit (post-treatment))
- Exhaled Carbon Monoxide (CO)(6-week visit (post-treatment))
- Urine Cotinine Concentration(6-week visit (post-treatment))
- Blood Pressure(6-week visit (post-treatment))
- Fagerstrom Test for Nicotine Dependence Mean Total Score(6-week visit (post-treatment))
- Penn State Electronic Cigarette Dependence Index(6-week visit (post-treatment))
- Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs)(6-week visit (post-treatment))
- Cigarettes Per Day(10-week visit (post-treatment))
- Total Score on Minnesota Nicotine Withdrawal Scale(1-week visit (post-treatment))
- E-cig Use Days(10-week visit (post-treatment))
- Number of Participants With Self-reported Abstinence(10-week visit (post-treatment))
- Heart Rate Variability (HRV)(6-week visit (post-treatment))
- Presence of Premature Ventricular Contractions (PVCs)(6-week visit (post-treatment))
- ST-Elevation(6-week visit (post-treatment))
- QRS Duration(6-week visit (post-treatment))
研究者
Jonathan Foulds
Professor
Milton S. Hershey Medical Center