Tobacco Cessation at FDNY

Trial Title: Tobacco Cessation at FDNY

NCT ID: NCT05997225

Condition: Tobacco Use
Tobacco Smoking
Tobacco Use Cessation

Conditions: Official terms:
Varenicline

Conditions: Keywords:
World Trade Center Health Program
occupational medicine
tobacco cessation
lifestyle medicine
opt-out treatment

Study type: Interventional

Study phase: Phase 4

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: opt out enrollment, tailored counseling, varenicline started prior to target quit date
Description: Participants automatically enrolled in motivational counseling. Tailored counseling includes sharing results of Chest CT results and lung function spirometry tests with participants.
Arm group label: Enhanced Treatment

Intervention type: Other
Intervention name: opt in enrollment, non-tailored counseling, varenicline started prior to target quit date
Description: Participants must opt-in to receive counseling. Counseling does not include discussion of Chest CT or spirometry results.
Arm group label: Standard Treatment

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 40 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: FDNY World Trade Center Health Program

Address:
City: Brooklyn
Zip: 11201
Country: United States

Status: Recruiting

Contact:
Last name: David Goldfarb, PhD

Phone: 718-403-4413

Start date: May 31, 2024

Completion date: October 2025

Lead sponsor:
Agency: Albert Einstein College of Medicine
Agency class: Other

Collaborator:
Agency: FDNY World Trade Center Health Program
Agency class: Other

Source: Albert Einstein College of Medicine

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05997225