Tobacco Cessation at FDNY

Tobacco Use Clinical Trial

Official title:

Preventing Lung Cancer Through Tobacco Cessation at FDNY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05997225
• Other study ID #: 2023-14980
• Status: Recruiting
• Phase: Phase 4
• Start date: May 31, 2024
• Est. completion date: October 2025

Study information

• Verified date: May 2024
• Source: Albert Einstein College of Medicine
• Contact: Shadi Nahvi, MD, MS
• Phone: 718 920 5379
• Email: shadi.nahvi[@]einsteinmed.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion

• Enrolled in FDNY 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

• Reduced renal function*

• estimated glomerular filtration rate (eGFR) <30 [CKD-EPI Creatinine Equation (2021)] at last 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 C-SSRS

• Screened for alcohol use disorder AUDIT>15

Related Conditions & MeSH terms

• Tobacco Smoking
• Tobacco Use
• Tobacco Use Cessation

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	FDNY World Trade Center Health Program	Brooklyn	New York

Sponsors (2)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	FDNY World Trade Center Health Program

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrollment	Enrollment is defined as first visit attendance with our tobacco treatment specialist in FDNY's Tobacco Cessation Program: Standard vs. Enhanced Care arms.	28 weeks
Secondary	Retention	Number of participants retained to study end-date	28 weeks
Secondary	Varenicline adherence	Pills taken / pills prescribed	week 16
Secondary	Counseling adherence	Adherence with number of counseling visits attended as a continuous variable	week 28
Secondary	Tobacco abstinence	7-day point prevalence abstinence biochemically verified by urine cotinine < 30 ng/mL and anabasine	end of treatment (16 weeks)