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Tobacco Cessation at FDNY

NCT05997225 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2026-01-29

No results posted yet for this 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.

Conditions

  • Tobacco Use
  • Tobacco Smoking
  • Tobacco Use Cessation

Interventions

OTHER

opt out enrollment, tailored counseling, varenicline started prior to target quit date

Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.

OTHER

opt in enrollment, non-tailored counseling, varenicline started prior to target quit date

Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.

Sponsors & Collaborators

  • FDNY World Trade Center Health Program

    collaborator UNKNOWN

  • National Institute for Occupational Safety and Health (NIOSH/CDC)

    collaborator FED

  • Albert Einstein College of Medicine

    lead OTHER

Principal Investigators

  • Shadi Nahvi, MD, MS · Albert Einstein College of Medicine

  • David Goldfarb, PhD · FDNY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-31
Primary Completion
2025-10-13
Completion
2025-10-13
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05997225 on ClinicalTrials.gov