CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 88 enrolled
Drug / intervention
Normal Nicotine Content research cigarettes +3 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/NCT04058717
NCT04058717N/ACompleted

Randomized Trial of Low Nicotine Cigarettes Plus Electronic Cigarettes in Smokers

Milton S. Hershey Medical Center·interventional·Posted Aug 15, 2019·Updated Sep 11, 2025

In Brief

A clinical study evaluating Normal Nicotine Content research cigarettes, High Nicotine e-cigarette, and 2 other interventions for Tobacco Dependence. Completed, enrolled 88 participants across 1 site.

Detailed Summary

This study aims to determine the health effects of very low nicotine content in cigarettes, in conjunction with the availability of nicotine-containing electronic cigarettes (e-cigs) among smokers with mental health conditions (SMHC).

Study Details

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

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 15, 2019
Enrollment StartJun 1, 2021
Primary CompletionJul 15, 2024
Study CompletionAug 12, 2024
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 6.9 years ago

Interventions

Normal Nicotine Content research cigarettesother

Research cigarettes with 11.6 mg nicotine/cigarette.

High Nicotine e-cigaretteother

E-cigarette containing high nicotine e-liquid

Very Low Nicotine Content research cigarettesother

Research cigarettes with 0.2 mg nicotine/cigarette.

Zero Nicotine e-cigaretteother

E-cigarette containing zero nicotine e-liquid