NCT05997225CompletedPhase 4
Tobacco Cessation at FDNY
Preventing Lung Cancer Through Tobacco Cessation at FDNY
Source: ClinicalTrials.gov · Last updated 29 Jan 2026
Brief summary (registry, in English)
At the Fire Department of the City of New York (FDNY) World Trade Center Health Program, 36% of participants in the low dose computed tomography (LDCT) lung cancer screening program are current smokers, despite referral to the free FDNY Tobacco Cessation Program (Standard Care). Investigators propose testing an Enhanced Care program which includes opt-out enrollment; tobacco cessation counseling will be individually tailored to spirometry/LDCT results and treatment with varenicline starting 4 weeks prior to their target quit date. This randomized trial will compare enrollment and cessation outcomes in Standard Care vs. Enhanced Care groups of challenging-to-treat, high-risk smokers.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 23 (actual)
- First submitted
- 10 Aug 2023
- Start date
- 31 May 2024
- Primary completion date
- 13 Oct 2025
- Lead sponsor
- Albert Einstein College of Medicine
- Diseases
- Lung cancer
- NCT number
- NCT05997225
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 23
- From 31 May 2024 to the primary completion date, 13 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Undergoing active cancer treatment, defined as being diagnosed on 1/1/2022 or later
- Screened for alcohol use disorder AUDIT\>15
Lab values
- estimated glomerular filtration rate (eGFR) \<30 \[CKD-EPI Creatinine Equation (2021)\] at last World Trade Center (WTC) medical monitoring blood exam OR ICD10 codes for kidney disease: N04.9, N17.9, N18.9, Z94.0, E13.21, N18.9, I12.9, N00.9, N03.9
Other
- Reduced renal function
- Clinical instability (e.g., hospitalization in last 3 months)
- Using varenicline in last 30 days
- Endorsing suicidal ideations: moderate or high risk on Columbia-Suicide Severity Rating Scale (C-SSRS)
Who the study is looking for
- Enrolled in FDNY World Trade Center Health Program (WTCHP)
- Retired
- Age ≥ 50 years old
- Self-reported current smoker on most recent questionnaire OR self-reported current smoker in the past 5 years
- 20 pack-year smoker OR 20-year smoking duration
Age in the registry: 40 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| FDNY World Trade Center Health Program Coordinator of this site? Confirm its status | Brooklyn | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.