CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 105 enrolled
Drug / intervention
Nicotine-Containing Electronic Cigarette +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03625986
NCT03625986N/ACompleted

Does Switching to Nicotine Containing Electronic Cigarettes Reduce Health Risk Markers

Milton S. Hershey Medical Center·interventional·Posted Aug 10, 2018·Updated Mar 27, 2025

In Brief

A clinical study evaluating Nicotine-Containing Electronic Cigarette and Non-Nicotine Electronic Cigarette for Tobacco Dependence. Completed, enrolled 105 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 10, 2018
Enrollment StartApr 22, 2022
Primary CompletionJan 26, 2024
Study CompletionFeb 23, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 7.9 years ago

Interventions

Nicotine-Containing Electronic Cigaretteother

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.

Non-Nicotine Electronic Cigaretteother

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.