N/A N=104 Randomized Quadruple-blind Other

Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

Tobacco Dependence

Bottom Line

View on ClinicalTrials.gov: NCT03625986 ↗

Enrolled (actual)

104

Serious AEs

1.0%

Results posted

Mar 2025

Primary outcome: Primary: Urinary NNAL Concentration — 151.6; 338.2 ng/ml — p=0.0039

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Nicotine-Containing Electronic Cigarette (Other); Non-Nicotine Electronic Cigarette (Other)
Age: Adult, Older Adult · 21+ yrs
Sex: All
Sponsor: Milton S. Hershey Medical Center
Primary completion: Jan 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Urinary NNAL Concentration	151.6; 338.2	0.0039 sig
SECONDARY Pulmonary Function	2.7; 2.7	0.8103
SECONDARY Exhaled Carbon Monoxide (CO)	10.7; 13.8	0.0105 sig
SECONDARY Urine Cotinine Concentration	5295.7; 2879.7	0.0182 sig
SECONDARY Blood Pressure	125.91; 124.74	0.8429
SECONDARY Fagerstrom Test for Nicotine Dependence Mean Total Score	3.69; 3.2	0.4881
SECONDARY Penn State Electronic Cigarette Dependence Index	7.21; 5.45	0.0835
SECONDARY Cigarettes Per Day	5.03; 6.47	0.1084
SECONDARY Number of Participants With Abstinence From Cigarettes and Other Tobacco (Not Including E-cigs)	19; 6	0.0052 sig
SECONDARY Total Score on Minnesota Nicotine Withdrawal Scale	4.2; 6.16	0.0797
SECONDARY Cigarettes Per Day	5.03; 6.47	0.1084
SECONDARY E-cig Use Days	6.69; 2.88	0.3469
SECONDARY Number of Participants With Self-reported Abstinence	20; 10	0.0272 sig
SECONDARY Heart Rate Variability (HRV)	35.2; 34.6	0.589
SECONDARY Presence of Premature Ventricular Contractions (PVCs)	2; 2.3	0.5448
SECONDARY ST-Elevation	103.1; 87.8	0.65
SECONDARY QRS Duration	94.3; 98.3	0.1567

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).

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03625986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.