Trial Outcomes & Findings for Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening (NCT NCT06472869)

NCT ID: NCT06472869

Last Updated: 2026-01-16

Results Overview

Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 15 participants
• Primary outcome timeframe: 4 weeks
• Results posted on: 2026-01-16

Participant Flow

Participant milestones

Measure	NJOY ACE E-cigarette Provision 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. NJOY ACE e-cigarette: 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
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	NJOY ACE E-cigarette Provision n=15 Participants 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. NJOY ACE e-cigarette: 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
Age, Continuous	66.1 years STANDARD_DEVIATION 5.9 • n=9 Participants
Sex: Female, Male Female	6 Participants n=9 Participants
Sex: Female, Male Male	9 Participants n=9 Participants
Race/Ethnicity, Customized Non-Hispanic White	13 Participants n=9 Participants
Race/Ethnicity, Customized Non-Hispanic Other	1 Participants n=9 Participants
Race/Ethnicity, Customized Hispanic	1 Participants n=9 Participants
Cigarettes Smoked Per Day	16.9 cigarettes/day STANDARD_DEVIATION 7.2 • n=9 Participants

PRIMARY outcome

Timeframe: 4 weeks

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

Participant enrollment, measured by the proportion of eligible participants who enroll in the study. Retention is measured by weeks of study participation.

Outcome measures

Measure

NJOY ACE E-cigarette Provision n=28 Participants 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. NJOY ACE e-cigarette: 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 Feasibility

15 Participants

PRIMARY outcome

Timeframe: 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)

Outcome measures

Measure	NJOY ACE E-cigarette Provision n=15 Participants 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. NJOY ACE e-cigarette: 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
Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision Baseline	16.9 cigarettes/day Standard Deviation 7.0
Cigarettes Per Day (CPD) Smoked During the Period of E-cigarette Provision Week 4	10.2 cigarettes/day Standard Deviation 7.0

SECONDARY outcome

Timeframe: 4 weeks

Change in participant's expired air carbon monoxide (CO) concentration assessed via Smokerlyzer during the period of e-cigarette provision (Baseline vs.week 4)

Outcome measures

Measure	NJOY ACE E-cigarette Provision n=15 Participants 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. NJOY ACE e-cigarette: 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
Carbon Monoxide (CO) Concentration in Expired Air Baseline	19.4 ppm Standard Deviation 11.0
Carbon Monoxide (CO) Concentration in Expired Air Week 4	12.3 ppm Standard Deviation 8.55

SECONDARY outcome

Timeframe: 4 weeks (Weeks 4-8)

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)

Outcome measures

Measure	NJOY ACE E-cigarette Provision n=14 Participants 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. NJOY ACE e-cigarette: 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
Cigarettes Smoked Per Day After E-cigarette Provision Ends Week 4	10.2 cigarettes/day Standard Deviation 7.0
Cigarettes Smoked Per Day After E-cigarette Provision Ends Week 8	9.7 cigarettes/day Standard Deviation 8.0

Adverse Events

NJOY ACE E-cigarette Provision

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	NJOY ACE E-cigarette Provision n=15 participants at risk 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. NJOY ACE e-cigarette: 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
Respiratory, thoracic and mediastinal disorders Coughing	6.7% 1/15 • Adverse event data were collected for 8 weeks Adverse event collection occurred at the end of every study visit using a form where participants were asked about serious adverse events since the previous visit.
General disorders Dizziness or headache	13.3% 2/15 • Adverse event data were collected for 8 weeks Adverse event collection occurred at the end of every study visit using a form where participants were asked about serious adverse events since the previous visit.

Additional Information

Nancy Rigotti, Study PI

Massachusetts General Hospital

Phone: 6177243548

Email: nrigotti@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place