NCT06472869Completed
Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Source: ClinicalTrials.gov · Last updated 16 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 19 Jun 2024
- Start date
- 23 Sept 2024
- Primary completion date
- 30 Apr 2025
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Lung cancer
- NCT number
- NCT06472869
What you commit to
- Study type: Interventional
- Participants enrolled: 15
- From 23 Sept 2024 to the primary completion date, 30 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Hospitalized for acute coronary syndrome, unstable angina, congestive heart failure, stroke, pneumonia or chronic pulmonary disease/asthma exacerbation in the past 1 month
Other
- 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
- Not willing to abstain from smoking marijuana in the 24h before each study visit
Who the study is looking for
- 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.
Age in the registry: 50 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.