David G Goldfarb, Tyrone Moline, David J Prezant, Matthew P Bars, Rachel Zeig-Owens, Theresa Schwartz, Madeline F Cannon, Brandon Vaeth, Julia H Arnsten, Mayris P Webber, Shadi Nahvi
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引用次数: 0
Abstract
Background: Cigarette smoking remains the leading preventable cause of death, posing heightened risks for vulnerable populations. World Trade Center (WTC) disaster responders face an elevated burden of respiratory diseases, and despite access to an evidence-based tobacco cessation program, a subset continues to smoke cigarettes. Treatment engagement remains a critical barrier, as many people who smoke fail to enroll in or adhere to programs, particularly when participation requires decisions to actively opt-in to treatment. This randomized controlled trial integrates tobacco treatment into an existing low-dose computed tomography (LDCT) lung cancer screening program and compares the effectiveness of an Enhanced Care intervention with opt-out enrollment and biofeedback to Standard Care with opt-in enrollment and standard treatment.
Methods: The trial includes retired Fire Department of the City of New York (FDNY) responders aged 50 years or older who have a smoking history that satisfies either the National Comprehensive Cancer Network criteria of at least 20 pack-years or a simplified criterion of at least 20 years of smoking. Participants are randomized to either Enhanced Care, featuring opt-out enrollment in tobacco treatment with tailored counseling using biofeedback from chest LDCT and spirometry results, or Standard Care, requiring opt-in enrollment and standard tobacco treatment without biofeedback. Both arms receive a varenicline regimen with 4 weeks of pre-loading. Primary outcomes are treatment enrollment and biochemically verified 7-day abstinence. Factors associated with enrollment and abstinence, including retention, adherence, and quit motivation, will be evaluated.
Discussion: This trial addresses a key gap in tobacco cessation research by testing an innovative intervention for a high-risk occupational cohort participating in LDCT screening. The Enhanced Care model integrates opt-out enrollment, personalized biofeedback, and varenicline preloading to reduce smoking rates and health burdens in FDNY responders. Findings aim to inform scalable cessation strategies for both occupational and general populations, highlighting the need for novel approaches for hard-to-treat individuals who smoke.
Trial registration: This trial was registered at ClinicalTrials.gov under the identifier NCT05997225.
期刊介绍：
Addiction Science & Clinical Practice provides a forum for clinically relevant research and perspectives that contribute to improving the quality of care for people with unhealthy alcohol, tobacco, or other drug use and addictive behaviours across a spectrum of clinical settings.
Addiction Science & Clinical Practice accepts articles of clinical relevance related to the prevention and treatment of unhealthy alcohol, tobacco, and other drug use across the spectrum of clinical settings. Topics of interest address issues related to the following: the spectrum of unhealthy use of alcohol, tobacco, and other drugs among the range of affected persons (e.g., not limited by age, race/ethnicity, gender, or sexual orientation); the array of clinical prevention and treatment practices (from health messages, to identification and early intervention, to more extensive interventions including counseling and pharmacotherapy and other management strategies); and identification and management of medical, psychiatric, social, and other health consequences of substance use.
Addiction Science & Clinical Practice is particularly interested in articles that address how to improve the quality of care for people with unhealthy substance use and related conditions as described in the (US) Institute of Medicine report, Improving the Quality of Healthcare for Mental Health and Substance Use Conditions (Washington, DC: National Academies Press, 2006). Such articles address the quality of care and of health services. Although the journal also welcomes submissions that address these conditions in addiction speciality-treatment settings, the journal is particularly interested in including articles that address unhealthy use outside these settings, including experience with novel models of care and outcomes, and outcomes of research-practice collaborations.
Although Addiction Science & Clinical Practice is generally not an outlet for basic science research, we will accept basic science research manuscripts that have clearly described potential clinical relevance and are accessible to audiences outside a narrow laboratory research field.
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