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Life sciences · Phase 4 Trial
ClinicalTrials.gov · November 5, 2026
No summary has been generated for this record yet. What follows is drawn from its source metadata only.
Phase 4 Trial.
No findings were extractable from the material analysed.
Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.
The source did not state who this applies to in practice.
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Registry record from ClinicalTrials.gov (NCT05997225). This is a study registration, not published results. Lead sponsor: Albert Einstein College of Medicine. Recruitment status: COMPLETED. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 23 participants (ACTUAL). Conditions: Tobacco Use, Tobacco Smoking, Tobacco Use Cessation. Interventions: 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. Primary outcome measures: Enrollment , Baseline (Week 0); Number of Participants With (Biochemically Validated) Tobacco Abstinence , Weeks 2, 4, 8, 12, and 16 along with a 12-week post end of treatment (EOT) timepoint visit at 28 weeks. 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.