Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05997225 |
Other study ID # |
2023-14980 |
Secondary ID |
|
Status |
Recruiting |
Phase |
Phase 4
|
First received |
|
Last updated |
|
Start date |
May 2024 |
Est. completion date |
October 2025 |
Study information
Verified date |
May 2024 |
Source |
Albert Einstein College of Medicine |
Contact |
Shadi Nahvi, MD, MS |
Phone |
718 920 5379 |
Email |
shadi.nahvi[@]einsteinmed.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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.
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.