CompletedNot applicableNCT06472869
Official study title

Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening

Study summary

This study investigates the feasibility, acceptability, and short-term effects of providing 4 weeks of complimentary electronic cigarettes (ECs) to 30 individuals who did not quit after smoking cessation treatment provided in the context of lung cancer screening and do not plan to quit smoking. This open-label single-arm pilot clinical trial will test the impact of EC provision on: 1) study feasibility, 2) EC acceptability, 3) tobacco use behavior (e.g., cigarettes per day, EC use), and 4) biomarkers (e.g., carbon monoxide, cotinine, and anabasine). Participants will be asked to switch from combustible cigarettes to the NJOY ACE 5% nicotine electronic cigarette (EC) for 4 weeks. They will be followed an additional 4 weeks after EC provision ends (to 8 weeks). The first study hypothesis is that more than 40% of eligible smokers who are offered participation in the trial will enroll, and that 75% of enrollees will complete the trial. The second study hypothesis is that participants will report fewer cigarettes smoked per day at the end of 4 weeks of EC provision, relative to their baseline values.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedNJOY ACE e-cigarette

The study team can explain what participation involves.

Who it may be forElectronic Cigarette Use · Smoking, Cigarette

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 16, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Massachusetts General Hospital

Study sponsor

01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Not applicable
Sponsor
Massachusetts General Hospital
Interventions being studied
Other: NJOY ACE e-cigarette
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • Participants who completed the Screen Assist study (NCT03611881) and self-reported smoking cigarettes at the end of the study were asked to complete a survey to ascertain their potential interest in participating in a research study to test the effects of switching from combustible cigarettes (CC) to electronic cigarettes (EC). Individuals who expressed interest in switching to EC on that survey were screened for eligibility for this pilot study
  • Smoked ≥5 cigarettes/day in past month
  • Smoking status at study entry confirmed by breath carbon monoxide (CO) ≥ 6ppm
  • Willing to try switching from CC to EC for 4 weeks
  • Owns a mobile telephone
  • English speaking
  • Willing to travel to the Massachusetts General Hospital campus for 3 in-person visits.
Reasons someone may not be able to joinExclusion criteria
  • Plans to quit smoking and has set a quit date in the next 30 days
  • Used smoking cessation treatment in the past 30 days
  • Used EC on \>2 days in the past 30 days
  • Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month
  • Not willing to abstain from smoking marijuana in the 24h before each study visit

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Massachusetts General HospitalBoston, Massachusetts

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 16, 2026. Always confirm current availability with the study team.

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