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Active, Not Recruiting

NCT Number: NCT03315910

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University of Southern California (Data Collection Only), Los Angeles, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Site Eligibility (as per SC self-report)

& Must be designated as an American College of Radiology (ACR) designated lung cancer screening site

  • Reports at least one year of lung cancer screening experience
  • Reports conducting at least 20 new initial screenings per month Site Coordinator (SC) Eligibility (as per SC self-report)
  • Employed as a full-time Site Coordinator at participating lung cancer screening site Patient Eligibility (as per self-report)
  • Between the ages of 50-80 years old
  • Seeking baseline or annual follow-up LDCT lung cancer screening
  • Have at least a 20 pack-year history of smoking
  • Currently a smoker, defined as self-reported cigarette smoking (some days, every day) within the past 30 days.
  • Must be reachable by telephone
  • Must be English or Spanish speaking due to the study materials being available in only these languages and limited available resources for translation.

Exclusion criteria

Patient (as per self-report)

  • NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or, unstable/worsening angina).
  • Smokers who are receiving other tobacco treatment services or have used cessation medications (NRT, bupropion, varenicline) within the past month.

Treatment and study plan

Motivational Interviewing (MI)

Behavioral

two counseling sessions

Nicotine replacement therapy (NRT)

Drug

receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day

Nicotine Lozenge

Drug

6 packs of NRT 2mg lozenge

Message Framing

Behavioral

health communication literature and quitting messages

Saliva Sample

Other

saliva samples from those reporting abstinence and analyze samples

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Oct 20, 2017
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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