Clinical trial · Interventional
Tobacco Cessation at FDNY
Preventing Lung Cancer Through Tobacco Cessation at FDNY
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Tobacco Smoking | — | UNRESOLVED | — |
| Tobacco Use | — | UNRESOLVED | — |
| Tobacco Use Cessation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| opt in enrollment, non-tailored counseling, varenicline started prior to target quit date | Other | — | UNRESOLVED |
| opt out enrollment, tailored counseling, varenicline started prior to target quit date | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Enhanced Care
- description
- Opt-out counseling enrollment. individually-tailored biofeedback linked to Chest CT and spirometry results. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date.
- interventionNames
- Other: opt out enrollment, tailored counseling, varenicline started prior to target quit date
- type
- ACTIVE_COMPARATOR
- label
- Standard Care
- description
- Opt-in counseling enrollment. Standard tobacco cessation counseling. Varenicline: Preloading regimen (prior to target quit date): 0.5 mg once a day for days 1-3, 0.5 mg twice a day for days 4-7, and 1 mg twice a day for days 8-28. 1 mg twice day for 12 weeks after target quit date.
- interventionNames
- Other: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria * 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 Exclusion Criteria * Reduced renal function * 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 * Undergoing active cancer treatment, defined as being diagnosed on 1/1/2022 or later * 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) * Screened for alcohol use disorder AUDIT\>15
References
Publications (1)
- RESULTGoldfarb DG, Moline T, Prezant DJ, Bars MP, Zeig-Owens R, Schwartz T, Cannon MF, Vaeth B, Arnsten JH, Webber MP, Nahvi S. Design of a randomized tobacco cessation trial among FDNY World Trade Center responders in a lung cancer screening program. Addict Sci Clin Pract. 2025 Aug 5;20(1):62. doi: 10.1186/s13722-025-00598-3. PMID 40765018