Clinical trial NCT05997225: Tobacco Cessation at FDNY
Official title: Preventing Lung Cancer Through Tobacco Cessation at FDNY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Tobacco Use
Tobacco Smoking
Tobacco Use Cessation
Keywords: World Trade Center Health Program
occupational medicine
tobacco cessation
lifestyle medicine
opt-out treatment
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: FDNY World Trade Center Health Program
First posted: 2023-08-18
Enrollment: 320
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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

Primary outcomes:
measure: Enrollment
timeFrame: Baseline (Week 0)
Secondary outcomes:
measure: Retention to Study End-Date
timeFrame: Through the 12-week post EOT timepoint at 28 weeks
measure: Counseling adherence
timeFrame: From baseline (Week 0) through each visit up to the 12-week post EOT timepoint visit at 28 weeks
measure: Tobacco Abstinence
timeFrame: From baseline (Week 0) through each research assessment visit up to the 12-week post EOT timepoint visit at 28 weeks
measure: Varenicline (pill count) adherence
timeFrame: Up through the time of the final research visit at Week 16
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: FDNY World Trade Center Health Program
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Shadi Nahvi, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: