Electronic Cigarette UseNCT06472869

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

A study testing NJOY ACE e-cigarette in people with Electronic Cigarette Use and Smoking, Cigarette, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 50 years and older
Conditions the study is for: Electronic Cigarette Use, Smoking, Cigarette, Nicotine Dependence
What is being tested?: NJOY ACE e-cigarette
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 15 participants
Where: 1 siteUnited States
Study dates: 23 Sep 2024to 30 Dec 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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.

Conditions: Electronic Cigarette Use, Smoking, Cigarette, Nicotine Dependence
Being tested: NJOY ACE e-cigarette
Keywords: Tobacco Use Disorder
Medical subject headings: Vaping, Cigarette Smoking, Tobacco Use Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NJOY ACE e-cigaretteOther
Patients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks

Study groups in NCT06472869
Study group	Role	What they receive
NJOY ACE e-cigarette provision	Experimental	Device: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks. Receives: Other: NJOY ACE e-cigarette

What is being measured

The primary outcome is the main question the study is designed to answer.

Study Feasibility
Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.
Measured: 4 weeks
Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision
Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4)
Measured: 4 weeks

Secondary outcomes (2)

Carbon Monoxide (CO) Concentration in Expired Air
Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4)
Measured: 4 weeks
Cigarettes Smoked Per Day After E-cigarette Provision Ends
Self-reported number of cigarettes smoked per day in the past week between end of e-cigarette provision and end of study (week 4 to week 8)
Measured: 4 weeks (Weeks 4-8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Sep 202430 Dec 2025

First posted25 Jun 2024
Study start23 Sep 2024
Primary completion30 Apr 2025
Study completion30 Dec 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Electronic Cigarette UseStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Open-label single-arm pilot clinical trial
Masking: None (open label)
Enrolment: 15 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06472869
Sponsor's protocol ID: 2024p001502
Status last verified: Jan 2026
First submitted: 19 Jun 2024
Last updated: 16 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
Tobacco Products, Cigarettes
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STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
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A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
Smoking, Tobacco
Recruiting
Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
E Cigarette Use
Recruiting
A Behavioral Circuit Breathing Training Intervention on Smoking Cessation and Respiratory Function Among Youth Who Use E-cigarettes
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All Electronic Cigarette Use trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
ClinicalTrials.gov ID: NCT06472869
Acronym / sponsor ID: 2024p001502
Conditions: Electronic Cigarette Use, Smoking, Cigarette, Nicotine Dependence
Keywords: Tobacco Use Disorder
Study type: Interventional
Recruitment status: Completed
Enrolment: 15 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: University of Massachusetts, Boston, Dana-Farber Cancer Institute
Study start: 23 Sep 2024 (actual)
Primary completion: 30 Apr 2025 (actual)
Study completion: 30 Dec 2025 (actual)
First posted: 25 Jun 2024 (actual)
Results: Posted 16 Jan 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Open-label single-arm pilot clinical trial

Arm	Type	Receives
NJOY ACE e-cigarette provision	Experimental	Other: NJOY ACE e-cigaretteDevice: NJOY ACE e-cigarette, 5% nicotine in tobacco flavor Patients will be provided with a NJOY ACE electronic cigarette for 4 weeks and asked to use the NJOY ACE as a substitute for smoking combustible cigarettes during the 4 weeks.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NJOY ACE e-cigarettePatients will be provided with NJOY ACE electronic cigarettes and 5% nicotine e-liquid cartridges in tobacco flavor for 4 weeks and asked to use the electronic cigarette as a substitute for smoking combustible cigarettes during the 4 weeks	Other	NJOY ACE e-cigarette provision

Primary outcome

Study Feasibility
Time frame: 4 weeks
Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.
Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision
Time frame: 4 weeks
Change in self-reported CPD smoked in the past week assessed using timeline follow-back (TLFB) between baseline and end of e-cigarette provision (Baseline vs.Week 4)

2 secondary outcomes

Carbon Monoxide (CO) Concentration in Expired Air
Time frame: 4 weeks
Cigarettes Smoked Per Day After E-cigarette Provision Ends
Time frame: 4 weeks (Weeks 4-8)

Results and safety

Results posted to the registry on 16 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NJOY ACE E-cigarette Provision	15	15

Primary outcome: Study Feasibility

Time frame: 4 weeks. Count of participants. Unit: Participants

Measure	NJOY ACE E-cigarette Provision n = 28
Value	15

Population analysed: The number of participants analyzed is different than the sample size as the outcome is participant enrollment among those eligible.

Primary outcome: Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision

Time frame: 4 weeks. Mean (Standard Deviation). Unit: cigarettes/day

Measure	NJOY ACE E-cigarette Provision n = 15
Baseline	16.9 (7.0)
Week 4	10.2 (7.0)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected for 8 weeks. Other adverse events reported at 0.2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NJOY ACE E-cigarette Provision	0 of 15 (0%)	3 of 15 (20%)	0 of 15

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Electronic Cigarette Use

Recruiting
Pilot Study of Communication for Dual Users of Cigarettes and E-cigarettes
Tobacco Products, Cigarettes
Recruiting
STEPS: Substance Use Trial of E-cigarettes or Pharmacotherapy for Smoking
Tobacco Use, Substance Use Disorders
Recruiting
A Study to Determine the Effect of Access to Multiple Tobacco Flavor Options on Smoking Abstinence Among Primary Cigarette Smokers Using an Electronic Nicotine Delivery System
Smoking, Tobacco
Recruiting
Circuit Breathing Exercise on Smoking Cessation Among Youth E-Cigarette Users
E Cigarette Use
Recruiting
A Behavioral Circuit Breathing Training Intervention on Smoking Cessation and Respiratory Function Among Youth Who Use E-cigarettes
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nancy A. Rigotti, MD principal investigator

Massachusetts General Hospital

Jaqueline C Avila, PhD principal investigator

University of Massachusetts, Boston

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NJOY ACE e-cigarette in people with Electronic Cigarette Use and Smoking, Cigarette, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Study Feasibility (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06472869.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.