Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

Conditions
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Tobacco Dependence

Intervention / Treatment
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* Other: Nicotine-Containing Electronic Cigarette
* Other: Non-Nicotine Electronic Cigarette


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine-Containing Electronic Cigarette<br>The experimental group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 58 mg/ml nicotine for the duration of 6 weeks. | Other: Nicotine-Containing Electronic Cigarette<br>* The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir (pod) and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 58 mg/mL of nicotine.<br>* Other names: 58 mg/mL Nicotine Content SREC;|
| Placebo Comparator: Non-Nicotine Electronic Cigarette<br>The placebo group will be provided with and encouraged to use a Standardized Research Electronic Cigarette (SREC) with liquid containing 0 mg/ml nicotine for the duration of 6 weeks. | Other: Non-Nicotine Electronic Cigarette<br>* The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a pod-based device and comprises a replaceable pre-filled liquid reservoir (pod) and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine.<br>* Other names: 0 mg/mL Nicotine Content SREC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary NNAL Concentration | Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine | 6-week visit (post-treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulmonary Function | Forced expiratory volume in one second (FEV1). | 6-week visit (post-treatment) | 
| Exhaled Carbon Monoxide (CO) | Exhaled CO (parts per million [ppm]) | 6-week visit (post-treatment) | 
| Plasma Cotinine Concentration | Cotinine (ng/ml) will serve as a measure of exposure to nicotine. | 6-week visit (post-treatment) | 
| Fagerstrom Test for Nicotine Dependence Mean Total Score | Nicotine dependence will be assessed via the Fagerstrom Test for Nicotine Dependence (FTND), a measure with total scores ranging from 0 (very low dependence) to 10 (very high dependence). | 6-week visit (post-treatment) | 
| Cigarettes per Day | Mean number of cigarettes smoked per day based on the past 7 days | 6-week visit (post-treatment) | 
| Abstinence from cigarettes and other tobacco (not including e-cigs) | Zero cigarettes or other tobacco products (not including e-cigs) used in the past days and a CO <6ppm | 6-week visit (post-treatment) | 
| Total Score on Minnesota Nicotine Withdrawal Scale | Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28. | 1-week visit (post-treatment) | 
| Cigarettes per day | Mean number of cigarettes smoked per day based on the past 7 days | 10-week visit (post-treatment) | 
| E-cig use days | The number of days the e-cig was used in the past 21 days | 10-week visit (post-treatment) | 
| Self-reported abstinence | Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days | 10-week visit (post-treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic cigarettes, nicotine, ecig, smoking