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

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

NCT ID: NCT06472869

Condition: Electronic Cigarette Use
Smoking, Cigarette
Nicotine Dependence

Conditions: Official terms:
Tobacco Use Disorder

Conditions: Keywords:
Tobacco Use Disorder

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Open-label single-arm pilot clinical trial

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: NJOY ACE e-cigarette
Description: 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
Arm group label: NJOY ACE e-cigarette provision

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 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. Exclusion Criteria: - 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

Gender: All

Minimum age: 50 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Massachusetts General Hospital

Address:
City: Boston
Zip: 02114
Country: United States

Contact:
Last name: Nancy A Rigotti, MD

Phone: 617-724-3548
Email: nrigotti@partners.org

Investigator:
Last name: Nancy A Rigotti, MD
Email: Principal Investigator

Start date: September 1, 2024

Completion date: August 31, 2025

Lead sponsor:
Agency: Massachusetts General Hospital
Agency class: Other

Collaborator:
Agency: University of Massachusetts, Boston
Agency class: Other

Collaborator:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Source: Massachusetts General Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06472869