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Randomized Controlled Trial
. 2025 Mar 1;185(3):284-291.
doi: 10.1001/jamainternmed.2024.7288.

Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Randomized Clinical Trial

Paul M Cinciripini  1 , Jennifer A Minnix  1 , George Kypriotakis  1 , Jeremy Erasmus  2 , Diane Beneventi  1 , Maher Karam-Hage  1 , Kelly Carpenter  3 , Robert J Volk  4 , Brett Carter  2 , Myrna C B Godoy  2 , Chad Strange  2 , Ya-Chen Tina Shih  5 , Yong Cui  1 , Charles E Green  6 , Jason D Robinson  1
Affiliations
Randomized Controlled Trial

Smoking Cessation Interventions in the Lung Cancer Screening Setting: A Randomized Clinical Trial

Paul M Cinciripini et al. JAMA Intern Med. .

Abstract

Importance: The optimal configuration of a smoking cessation intervention in a lung cancer screening (LCS) setting has not yet been established.

Objective: To evaluate the efficacy of 3 tobacco treatment strategies of increasing integration and intensity in the LCS setting.

Design, setting, and participants: In this randomized clinical trial, LCS-eligible current smokers were randomized into 3 treatments: quitline (QL), QL plus (QL+), or integrated care (IC). The study was conducted from July 2017 to June 2022 at a hospital-based tobacco treatment clinic in Houston, Texas.

Interventions: The QL intervention group had quitline referral and 12-week nicotine replacement therapy (NRT). The QL+ group had quitline referral plus 12-week NRT or pharmacotherapy prescribed by the LCS clinician. The IC group had 12-week NRT or prescription pharmacotherapy and counseling provided by tobacco treatment specialists within the LCS health care environment.

Main outcomes and measures: The original primary outcome was biochemically verified 7-day point prevalence abstinence at 6 months; however, this was changed to self-reported abstinence during the conduct of the study due to COVID-19 pandemic restrictions.

Results: Of 630 participants, 320 (50.8%) were male, and the median (IQR) age was 59 (55-64) years. Participants smoked a median (IQR) of 20 (15-25) cigarettes per day. Each cohort (QL, QL+, and IC) was composed of 210 participants. The median (IQR) number of counseling sessions was 4 (2-5) sessions for both QL and QL+ and 8 (7-9) sessions for IC. At 3 months, 53 participants (25.2%) in QL, 57 (27.1%) in QL+, and 78 (37.1%) in IC reported abstinence. IC outperformed both QL (odds ratio [OR], 1.75 [95% CI, 1.15-2.66]; P = .01) and QL+ (OR, 1.58 [95% CI, 1.05-2.40]; P = .03). At 6 months, IC maintained the highest rate of abstinence with 68 individuals (32.4%), followed by QL+ at 58 (27.6%) and QL at 43 (20.5%). IC outperformed QL at this time point (OR, 1.86 [95% CI, 1.19-2.89]; P = .01). In the bayesian analysis, IC demonstrated a higher probability of positive absolute risk differences (ARDs) in abstinence at 3 months vs QL (ARD, 0.12) with 99% probability of positive ARD, and QL+ (ARD, 0.10) with 98% probability of positive ARD. This advantage was maintained at 6 months with ARDs of 0.12 for QL (probability of positive ARD, 99%) and 0.05 for QL+ (probability of positive ARD, 86%).

Conclusions and relevance: In this randomized clinical trial, IC involving medication and intensive counseling provides the best opportunity for smoking cessation relative to QL counseling, with or without LCS clinician-managed medication. Although IC consistently outperformed QL and QL+, differences with QL+ were reduced at 6 months, suggesting QL+ could be considered in low-resource settings.

Trial registration: ClinicalTrials.gov Identifier: NCT03059940.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Cinciripini reported nonfinancial support from Pfizer, which provided varenicline for various National Institutes of Health (NIH)–funded studies. Dr Carpenter reported grants from UnitedHealth Group during the conduct of the study. Dr Godoy reported grants from Siemens Healthineers outside the submitted work. Dr Shih reported receiving research funding (paid to the institution) from the National Cancer Institute (NCI R01CA225647) and serves on Sanofi's OncoCollective Advisory Board. Dr Cui reported grants from NIH and NCI during the conduct of the study. Dr Green reported grants from NIH and the American Association for Cancer Research outside the submitted work. No other disclosures were reported.

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