Tobacco Cessation at FDNY

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 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Tobacco Use; Tobacco Smoking; Tobacco Use Cessation
• Intervention / Treatment: Other: opt out enrollment, tailored counseling, varenicline started prior to target quit date; Other: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date

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 participating in 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 CT tailoring, and varenicline with preloading) in the engagement of high-risk smokers in cessation treatment and the achievement of tobacco abstinence.

• Study Type: Interventional
• Enrollment (Estimated): 220
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Shadi Nahvi, MD, MS; Phone Number: 718 920 5379; Email: shadi.nahvi@einsteinmed.edu
• Study Contact Backup: Name: David Goldfarb, PhD; Phone Number: 718 403 4413; Email: david.goldfarb@fdny.nyc.gov

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11201
      • FDNY World Trade Center Health Program
      • Contact: David Goldfarb, PhD; Phone Number: 718-403-4413

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• self-reported current smoker as of participants' most recent FDNY World Trade Center Health Program questionnaire
• Enrolled in the FDNY World Trade Center Health Program Chest CT program
• Previously provided informed consent to World Trade Center Health Program Research

Exclusion Criteria:

• use of varenicline in past 30 days
• psychiatric instability (exacerbations in prior 3 months; current suicidal ideation or attempt, psych hospitalizations in past year)
• seizures
• pregnancy or breast feeding.
• alcohol use disorders

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enhanced Treatment; 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; Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.
Active Comparator: Standard Treatment; 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; Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Retention	Number of participants retained to study end-date	28 weeks
Varenicline adherence	Assessed via electronic medication monitoring: pills taken / pills prescribed	week 16
Counseling adherence	Adherence with number of counseling visits attended as a continuous variable	week 28
Tobacco abstinence	7-day point prevalence abstinence biochemically verified by urine cotinine < 30 ng/mL	end of treatment (16 weeks)

Collaborators and Investigators

• Sponsor: Albert Einstein College of Medicine
• Collaborators: FDNY World Trade Center Health Program
• Investigators: Principal Investigator: Shadi Nahvi, MD, MS, Albert Einstein College Of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: tobacco cessation; lifestyle medicine; occupational medicine; World Trade Center Health Program; opt-out treatment
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2023-14980

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Deidentified data set

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes