Tobacco Cessation at FDNY

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedopt out enrollment, tailored counseling, varenicline started prior to target quit date and opt in enrollment, non-tailored counseling, varenicline started prior to target quit date

The study team can explain what participation involves.

Who it may be forTobacco Use · Tobacco Smoking

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Jan 29, 2026 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 4

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Albert Einstein College of Medicine

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 4
Sponsor: Albert Einstein College of Medicine
Interventions being studied: Other: opt out enrollment, tailored counseling, varenicline started prior to target quit date; Other: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date

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How this study is categorized

These labels come from structured fields and exact terms in the public record.

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion 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

Reasons someone may not be able to joinExclusion 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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

Study sites

U.S. locations

FDNY World Trade Center Health ProgramBrooklyn, New York

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 29, 2026. Always confirm current availability with the study team.

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