Tobacco UsePhase 4NCT05997225
Tobacco Cessation at FDNY
A Phase 4 study testing opt 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 in people with Tobacco Use and Tobacco Smoking, run by Albert Einstein College of Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
- What is being tested?
- opt 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
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 31 May 2024to 13 Oct 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
FDNY World Trade Center Health Program
Brooklyn, New York, 11201
About this study
Official title: Preventing Lung Cancer Through Tobacco Cessation at FDNY
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.
Read the 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
- Being tested
- opt out enrollment, tailored counseling, varenicline started prior to target quit date, opt in enrollment, non-tailored counseling, varenicline started prior to target quit date
- Keywords
- World Trade Center Health Program, occupational medicine, tobacco cessation, lifestyle medicine, opt-out treatment
- Medical subject headings
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
opt out enrollment, tailored counseling, varenicline started prior to target quit dateOther
Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.
opt in enrollment, non-tailored counseling, varenicline started prior to target quit dateOther
Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Retention will be assessed and reported as the number of participants retained in the study through the time of the 12-week post end of treatment (EOT) timepoint at 28 weeks.
Measured: Through the 12-week post EOT timepoint at 28 weeks
Counseling adherence
Counseling adherence will be determined by the number of counseling visits attended. Tobacco counseling sessions 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. Counseling adherence will be summarized by study arm based on attendance during each individual session (timepoint) and reported as a continuous variable for each timepoint (counseling visit).
Measured: From baseline (Week 0) through each visit up to the 12-week post EOT timepoint visit at 28 weeks
Varenicline (pill count) adherence
Varenicline adherence will be measured using pill counts, recorded as the pills taken / pills prescribed (i.e., the number of pills taken divided by the number of pills prescribed) per participant, corresponding to the dosing regimen. Varenicline adherence data will be summarized by study arm using basic descriptive statistics. Medication adherence rates in excess of 100% (e.g., subjects mistakenly took extra pills) will be reported as 100% adherence. Similarly, medication adherence rates below zero (e.g., subjects added pills to the bottle but did not remove any pills) will be reported as 0% adherence. Pill count adherence is an objective measure that has been shown to correlate with electronic monitors and varenicline plasma levels.
Measured: Up through the time of the final research visit at Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start31 May 2024
- Primary completion13 Oct 2025
- Study completion13 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Albert Einstein College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- FDNY World Trade Center Health Program, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Responsible party
- Sponsor
- Investigators
- Shadi Nahvi, MD, MS, Principal investigator, Albert Einstein College of MedicineDavid Goldfarb, PhD, Principal investigator, FDNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997225
- Sponsor's protocol ID
- 2023-14980
- Other IDs
- R21OH012256, 2023
- Status last verified
- Jan 2026
- First submitted
- 10 Aug 2023
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Deidentified data set
Publications
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.
PubMed 40765018
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Lung Cancer Through Tobacco Cessation at FDNY
- ClinicalTrials.gov ID
- NCT05997225
- Acronym / sponsor ID
- 2023-14980
- Conditions
- Tobacco Use, Tobacco Smoking, Tobacco Use Cessation
- Keywords
- World Trade Center Health Program, occupational medicine, tobacco cessation, lifestyle medicine, opt-out treatment
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Albert Einstein College of MedicineUniversity, hospital or other
- Collaborators
- FDNY World Trade Center Health Program, National Institute for Occupational Safety and Health (NIOSH/CDC)
- Study start
- 31 May 2024 (actual)
- Primary completion
- 13 Oct 2025 (actual)
- Study completion
- 13 Oct 2025 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced Care | Experimental | Other: opt out enrollment, tailored counseling, varenicline started prior to target quit dateOpt-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. |
| Standard Care | Active comparator | Other: opt in enrollment, non-tailored counseling, varenicline started prior to target quit dateOpt-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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| opt out enrollment, tailored counseling, varenicline started prior to target quit dateParticipants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants. | Other | Enhanced Care |
| opt in enrollment, non-tailored counseling, varenicline started prior to target quit dateParticipants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results. | Other | Standard Care |
Primary outcome
Enrollment
Time frame: Baseline (Week 0)
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.
Tobacco Abstinence
Time frame: From baseline (Week 0) through each research assessment visit up to the 12-week post EOT timepoint visit at 28 weeks
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.
3 secondary outcomes
Retention to Study End-Date
Time frame: Through the 12-week post EOT timepoint at 28 weeks
Counseling adherence
Time frame: From baseline (Week 0) through each visit up to the 12-week post EOT timepoint visit at 28 weeks
Varenicline (pill count) adherence
Time frame: Up through the time of the final research visit at Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Results publication: PubMed 40765018Goldfarb 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.
- Individual participant dataSharing planned: Undecided. Deidentified data set
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shadi Nahvi, MD, MS principal investigator
Albert Einstein College of Medicine
David Goldfarb, PhD principal investigator
FDNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing opt 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 in people with Tobacco Use and Tobacco Smoking, run by Albert Einstein College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment (time frame: Baseline (Week 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05997225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.