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

NCT06472869 | Completed Results

• 1 other identifier: 2024p001502
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tobacco Use Disorder

Outcome Measures

Primary Outcomes (2)

• Study Feasibility

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

  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)

  4 weeks

Secondary Outcomes (2)

• Carbon Monoxide (CO) Concentration in Expired Air

  4 weeks

• Cigarettes Smoked Per Day After E-cigarette Provision Ends

  4 weeks (Weeks 4-8)

Study Arms (1)

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.

Other: NJOY ACE e-cigarette

Interventions

NJOY ACE e-cigarette OTHER

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

NJOY ACE e-cigarette provision

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• University of Massachusetts, Boston: collaborator
• Dana-Farber Cancer Institute: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Vaping; Cigarette Smoking; Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Smoking; Behavior; Tobacco Smoking; Tobacco Use; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: Nancy Rigotti, Study PI
• Organization: Massachusetts General Hospital

nrigotti@mgh.harvard.edu

6177243548

Study Officials

• Nancy A. Rigotti, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Jaqueline C Avila, PhD

  University of Massachusetts, Boston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Harvard Medical School

Model Details: Open-label single-arm pilot clinical trial

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: September 23, 2024
• Primary Completion: April 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 16, 2026
• Results First Posted: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)