Tobacco Cessation at FDNY

NCT ID: NCT05997225

Last Updated: 2026-01-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-31
• Study Completion Date: 2025-10-13

Brief 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.

Detailed Description

The overarching goal of this Randomized Controlled trial is to develop and test an effective, scalable intervention with potential to reach high-risk smokers undergoing CT lung cancer screening who have not engaged in or succeeded with traditional tobacco treatment approaches. The investigators will test an Enhanced Care intervention specifically designed to address multiple challenges to tobacco treatment engagement and success. First, the researchers will test opt-out enrollment in cessation treatment. The current tobacco treatment default, in which patients must opt-in to cessation treatment and are only offered counseling and pharmacotherapy when deemed ready to quit, results in missed opportunities to engage smokers into treatment. Previous studies of opt-out enrollment in cessation treatment suggest that an opt-out tobacco treatment strategy substantially increases engagement and cessation rates compared with traditional opt-in approaches. Second, proactive counseling will leverage the "reachable, teachable moment" of CT screening to motivate cessation through individually tailored messaging tied to CT results and lung function spirometry. Using CT results as a motivational tool has shown promise in pilot studies. The optimal approach and success of using CT coupled with spirometry results to motivate tobacco cessation remains unknown. Third, investigators will offer varenicline pre-loading to all enrollees, regardless of study arm, in which varenicline is initiated 4 weeks prior to target quit date. This approach is associated with decreased pre-quit tobacco-associated reward and double the rate of abstinence compared with standard varenicline treatment.

The investigators thus propose a randomized trial among retired FDNY World Trade Center Health Program responders eligible for the FDNY World Trade Center Health Program CT screening program to test the effects of Enhanced Care (opt-out enrollment, tailored counseling based on CT and spirometry results, and varenicline with preloading) against Standard Care (opt-in enrollment, standard cessation counseling without spirometry/CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Cessation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Enhanced Care

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.

Group Type: EXPERIMENTAL

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

Intervention Type: OTHER

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

Standard Care

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.

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Albert Einstein College of Medicine

OTHER

Sponsor Role: lead

FDNY World Trade Center Health Program

UNKNOWN

Sponsor Role: collaborator

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

FED

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shadi Nahvi, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

David Goldfarb, PhD

Role: PRINCIPAL_INVESTIGATOR

FDNY

Locations

FDNY World Trade Center Health Program

Brooklyn, New York, United States

Countries

United States

References

Goldfarb 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.

Reference Type: RESULT

PMID: 40765018 (View on PubMed)

Other Identifiers

R21OH012256

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2023-14980

Identifier Type: -

Identifier Source: org_study_id