Tobacco Use Clinical Trial
Official title:
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.
Status | Not yet recruiting |
Enrollment | 220 |
Est. completion date | September 2025 |
Est. primary completion date | September 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | FDNY World Trade Center Health Program | Brooklyn | New York |
Lead Sponsor | Collaborator |
---|---|
Albert Einstein College of Medicine | FDNY World Trade Center Health Program |
United States,
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 | Assessed via electronic medication monitoring: 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 | end of treatment (16 weeks) |
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