Clinical trial NCT06472869: Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Official title: Assessing E-Cigarettes for Tobacco Harm Reduction in the Context of Lung Cancer Screening
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Electronic Cigarette Use
Smoking, Cigarette
Nicotine Dependence
Keywords: Tobacco Use Disorder
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Massachusetts, Boston
name: Dana-Farber Cancer Institute
First posted: 2024-06-25
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Open-label single-arm pilot clinical trial
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Study feasibility
timeFrame: 4 weeks
measure: Cigarettes per day (CPD) smoked during the period of e-cigarette provision
timeFrame: 4 weeks
Secondary outcomes:
measure: Carbon monoxide (CO) concentration in expired air
timeFrame: 4 weeks
measure: Urine anabasine concentration
timeFrame: 4 weeks
measure: Urine cotinine concentration
timeFrame: 4 weeks
measure: Cigarettes smoked per day after e-cigarette provision ends
timeFrame: 4 weeks (Weeks 4-8)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Nancy A. Rigotti, MD
role: PRINCIPAL_INVESTIGATOR
References: