Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

Not Applicable

Completed

Conditions: Tobacco Dependence

Interventions: Other: Non-Nicotine Electronic Cigarette
Other: Nicotine-Containing Electronic Cigarette

Registration Number: NCT03625986

Lead Sponsor: Milton S. Hershey Medical Center

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 105

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Nicotine Electronic Cigarette	Non-Nicotine Electronic Cigarette	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.
Nicotine-Containing Electronic Cigarette	Nicotine-Containing Electronic Cigarette	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.

Primary Outcome Measures

Name	Time	Method
Urinary NNAL Concentration	6-week visit (post-treatment)	Concentration of urinary carcinogen biomarker of exposure, NNAL, corrected for creatinine

Secondary Outcome Measures

Name	Time	Method
Pulmonary Function	6-week visit (post-treatment)	Forced expiratory volume in one second (FEV1).
Exhaled Carbon Monoxide (CO)	6-week visit (post-treatment)	Exhaled CO (parts per million \[ppm\])
Urine Cotinine Concentration	6-week visit (post-treatment)	Cotinine (ng/ml) will serve as a measure of exposure to nicotine.
Blood Pressure	6-week visit (post-treatment)	systolic blood pressure in mm Hg
Fagerstrom Test for Nicotine Dependence Mean Total Score	6-week visit (post-treatment)	Nicotine dependence for cigarettes 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).
Penn State Electronic Cigarette Dependence Index	6-week visit (post-treatment)	Nicotine dependence for e-cigarettes will be assessed via the Penn State Electronic Nicotine Dependence Index, a measure with total scores ranging from 0 (very low dependence) to 20 (very high dependence).
Cigarettes Per Day	10-week visit (post-treatment)	Mean number of cigarettes smoked per day based on the past 7 days
Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs)	6-week visit (post-treatment)	Zero cigarettes or other tobacco products (not including e-cigs) used in the past 7 days and a CO \<6ppm
Total Score on Minnesota Nicotine Withdrawal Scale	1-week visit (post-treatment)	Withdrawal and craving will be assessed via the Minnesota Nicotine Withdrawal Scale. Total scores range from 0-28. Higher scores indicate worse withdrawal symptoms.
E-cig Use Days	10-week visit (post-treatment)	The number of days the e-cig was used since 6-week visit (post-treatment)
Number of Participants With Self-reported Abstinence	10-week visit (post-treatment)	Abstinence will be considered zero cigarettes and other tobacco products (not including e-cigs) in the past 7 days
Heart Rate Variability (HRV)	6-week visit (post-treatment)	Heart Rate Variability (HRV) will be assessed from resting Holter EKG output.
Presence of Premature Ventricular Contractions (PVCs)	6-week visit (post-treatment)	Presence of PVCs will be assessed from resting Holter EKG output.
ST-Elevation	6-week visit (post-treatment)	ST-Elevation will be assessed from resting Holter EKG output
QRS Duration	6-week visit (post-treatment)	QRS duration will be assessed from resting Holter EKG output.