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

NCT06472869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2026-01-16

Study results available
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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.

Conditions

  • Electronic Cigarette Use
  • Smoking, Cigarette
  • Nicotine Dependence

Interventions

OTHER

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

Sponsors & Collaborators

  • University of Massachusetts, Boston

    collaborator OTHER

  • Dana-Farber Cancer Institute

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Nancy A. Rigotti, MD · Massachusetts General Hospital

  • Jaqueline C Avila, PhD · University of Massachusetts, Boston

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-23
Primary Completion
2025-04-30
Completion
2025-12-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06472869 on ClinicalTrials.gov