NCT03315910

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

Active, enrolled Phase 4 Last updated 21 November 2025

What this trial tests

Phase 4 trial testing Motivational Interviewing (MI) in Smoking Cessation in 807 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

10 October 2017

Primary endpoint
1 October 2026

1 October 2026

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 4
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	none
Primary purpose	prevention
Enrollment	807
Start date	10 October 2017
Primary completion	1 October 2026
Estimated completion	1 October 2026
Sites	18 locations across United States

Drugs / interventions tested

• Motivational Interviewing (MI)
• Nicotine Replacement Therapy (NRT) (nicotine-replacement-therapy-nrt) — full drug profile →
• Nicotine Lozenge — full drug profile →
• Message Framing
• saliva sample — full drug profile →

Conditions studied

• Smoking Cessation — all drugs for Smoking Cessation →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

Adults 50 to 80, any sex, with Smoking Cessation. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• number of patients who are tobacco abstinence
  Time frame: 6 months following study enrollment
  biochemical verification of smoking abstinence will be conducted Consistent with Intent to Treat, unless self reported smoking abstinence is biochemically verified, (\<3 ng/ml for mailed salivary cotinine assay) for participants who fail to return the saliva sample, the cessation outcome will be considered non-abstinent.

Sponsor's own description

This study is to help determine the most effective type or combination of treatments to offer patients seeking lung cancer screening who are smokers to help them reduce the number of cigarettes they smoke, or quit smoking. The investigators long term goal is to increase the benefits of lung cancer screening by providing a blue print of best practices for screening sites to deliver tobacco treatment to their patients who are smokers, in a way that does not add burden to screening site staff and increases the chances of patients quitting smoking.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings.
   Ostroff JS, Shelley DR, Chichester LA, King JC, et al · · 2022 · cited 5× · PMID 35978334 · DOI 10.1186/s13063-022-06568-3
2. Predictors of Enrollment of Older Smokers in Six Smoking Cessation Trials in the Lung Cancer Screening Setting: The Smoking Cessation at Lung Examination (SCALE) Collaboration.
   Eyestone E, Williams RM, Luta G, Kim E, et al · · 2021 · cited 5× · PMID 34077535 · DOI 10.1093/ntr/ntab110
3. Study protocol of a multiphase optimization strategy trial for delivery of smoking cessation treatment in lung cancer screening settings
   Ostroff J, Shelley D, Chichester L, King JC, et al · · 2022 · DOI 10.21203/rs.3.rs-1044243/v1