Tobacco Cessation at FDNY

NCT05997225 | Completed Phase 4 DMC FDA Drug

• 2 other identifiers: 2023-14980R21OH012256
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Cessation; Tobacco Use; Tobacco Smoking

Keywords

World Trade Center Health Program; occupational medicine; tobacco cessation; lifestyle medicine; opt-out treatment

Outcome Measures

Primary Outcomes (2)

• Enrollment

  Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms. The number of participants who attend the first visit with the tobacco treatment specialist will be tabulated and reported.

  Baseline (Week 0)

• Tobacco Abstinence

  7-day point prevalence abstinence will be biochemically verified by the analysis of urine samples collected at a laboratory nearest each participant's residence. Urine samples collection will occur at baseline, and at weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint at 28 weeks. Samples will be analyzed for urine cotinine which is the commonly measured biomarker of nicotine intake. Urine cotinine levels \< 20 ng/mL will be used to verify tobacco abstinence. Data will be summarized at each timepoint by study arm using basic descriptive statistics at each research assessment visit.

  From baseline (Week 0) through each research assessment visit up to the 12-week post EOT timepoint visit at 28 weeks

Secondary Outcomes (3)

• Retention to Study End-Date

  Through the 12-week post EOT timepoint at 28 weeks

• Counseling adherence

  From baseline (Week 0) through each visit up to the 12-week post EOT timepoint visit at 28 weeks

• Varenicline (pill count) adherence

  Up through the time of the final research visit at Week 16

Study Arms (2)

Enhanced Care

EXPERIMENTAL

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.

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

Standard Care

ACTIVE COMPARATOR

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.

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

Interventions

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

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

Standard Care

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

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

Enhanced Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• pack-year smoker OR 20-year smoking duration

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator
• FDNY World Trade Center Health Program: collaborator

Study Sites (1)

FDNY World Trade Center Health Program

Brooklyn, New York, 11201, United States

Location

Related Publications (1)

• 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.

  PMID: 40765018 RESULT

MeSH Terms

Conditions

Tobacco Use; Tobacco Smoking; Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Behavior; Smoking; Health Behavior

Study Officials

• Shadi Nahvi, MD, MS

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

• David Goldfarb, PhD

  FDNY

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: May 31, 2024
• Primary Completion: October 13, 2025
• Study Completion: October 13, 2025
• Last Updated: January 29, 2026

Record last verified: 2026-01

Locations

US (1)