This phase IV trial tests the effectiveness of a strategy specifically designed to address the challenges of getting people to start and succeed with tobacco treatment. Cigarette smoking is a leading cause of disease and death in the US. Many effective treatments exist to help people quit smoking, but people who smoke often do not use medications, or do not use medications long enough to get their full benefit. Varenicline is approved for use in helping people to quit smoking. Varenicline works by blocking nicotine receptors (group of cells that receives an action or response that can trigger a physical or behavioral change) in the brain. When people smoke while taking varenicline, it blocks the cigarette's enjoyable effects; it also reduces the craving and other symptoms associated with withdrawing from nicotine. Varenicline may help reduce nicotine use, even if people are not ready to quit.
Additional locations may be listed on ClinicalTrials.gov for NCT05997225.
Locations matching your search criteria
United States
New York
Bronx
Montefiore Medical Center-Weiler HospitalStatus: Active
Contact: David G. Goldfarb
Phone: 718-403-4413
PRIMARY OBJECTIVES:
I. To compare enrollment (proportion participating in first visit with our tobacco treatment specialist) in the Fire Department of the City of New York (FDNY) World Trade Center Health Program (WTCHP) Tobacco Cessation Program by standard care versus (vs.) enhanced care methods.
Ia. To evaluate demographic and clinical characteristics associated with FDNY Tobacco Cessation
Program enrollment.
II. To compare outcomes (retention to study end-date, varenicline and counseling adherence and tobacco abstinence rates) in the FDNY Tobacco Cessation Program by standard care vs. enhanced care methods.
IIa. To evaluate demographic and clinical characteristics associated with FDNY Tobacco Cessation
Program outcomes.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants receive varenicline once daily (QD) on days 1-3, twice daily (BID) on days 4-7 and then BID thereafter for 16 weeks prior to their target quit date followed by an additional 12 weeks of varenicline treatment. Participants also attend tailored tobacco cessation counseling based on Public Health Service guidelines, along with personalized biofeedback addressing computed tomography (CT) and spirometry results, varenicline support, and lung cancer risk reduction via telehealth at baseline, 2, 4, 8, 12, 16, and 28 weeks.
GROUP II: Participants receive varenicline QD on days 1-3, BID on days 4-7 and then BID thereafter for 16 weeks prior to their target quit date followed by an additional 12 weeks of varenicline treatment. Participants also attend standard tobacco cessation counseling based on Public Health Service guidelines and varenicline support via telehealth at baseline, 2, 4, 8, 12, 16, and 28 weeks.
After completion of study intervention, participants are followed up at 28 weeks.
Lead OrganizationMontefiore Medical Center-Weiler Hospital
Principal InvestigatorDavid G. Goldfarb
