ClinicalTrials.gg
Active, not recruitingNCT03315910Updated Nov 3, 2026

Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites

A Phase 4 interventional study of Motivational Interviewing (MI) and Nicotine Replacement Therapy (NRT) in Smoking Cessation, sponsored by Memorial Sloan Kettering Cancer Center. Active, not recruiting at 18 sites in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.

Sponsored by Memorial Sloan Kettering Cancer Center · Phase 4, Interventional, and Prevention

Updated Nov 3, 2026Primary completion movedStudy completion movedGo to Updates ↓

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Phase
Phase 4
Study type
Interventional
Enrollment
807
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 920 studies in Smoking Cessation with a site in United States — 98 open to participants now, 126 under way, 7 of them phase 3. Smoking Cessation · United States.

Enrollment
129th of 872
807 · median 149
Started
2017
with 39 others
Phase 4
99 of 920
7 open now
Primary completion
2027-10
later than 77 of 125 live
Registered
556th of 920
by date

Among the 920 studies in Smoking Cessation with a site in United States, this one is the 129th largest by enrollment of the 872 interventional ones that give a count, is one of 40 that started in 2017, is one of 99 in phase 4, reaches primary completion later than 77 of the 125 other live ones, and was the 556th registered.

Smoking Cessation

1,582 studies on the registry are indexed under Smoking Cessation; 198 are open to participants now.

Browse Smoking Cessation studies →

Open to participants now

98 of the 920 studies in Smoking Cessation with a site in United States are open now. Recruiting first, the newest first:

93 more — sign in →

All 98 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 137 Smoking Cessation studies recruiting now, 93 (68%) set no upper age limit and 37 (27%) stop at 75 or younger; 6 take children under 18; 41 take healthy volunteers.

This study: 50 Years to 80 Years · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 920 studies in Smoking Cessation with a site in United States, or all of them as a file.
02

Study summary

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.

03

Conditions studied

  • Smoking Cessation

Browse trials for

Keywords

  • Tobacco Treatment
  • Lung CT
  • Cancer Screening
  • 17-500
04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

Patient (as per self-report)

  • NRT is medically (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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
807 participants (actual)

Study arms

  • Experimental
    Motivational Interviewing( MI) (Yes vs. No)

    Participants will receive two motivational informed cessation sessions; the first delivered face to faceor via telephone by the SC during the patient's initial lung cancer screening visit or during the shared decision making discussion or within about 1 week following their screening visit, and the second session delivered by telephone by the SC approximately 4 to 8 weeks after the first MI session.

    Behavioral: Motivational Interviewing (MI) · Other: saliva sample

  • Experimental
    Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)

    Participants will receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day and written instructions to use the patch daily starting on date they mutually agreed upon with their site coordinator. Participants who smoke fewer than 10 cigarettes per day will receive 4-weeks of the 14mg patch (2 boxes), and 2-weeks of the 7mg patch (1 box). Those who smoke 10 or more cigarettes per day will receive 4-weeks of the 21mg patch (2 boxes) and 2-weeks of the 14mg patch (1 box). Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.

    Drug: Nicotine Replacement Therapy (NRT) · Other: saliva sample

  • Experimental
    NRT Lozenge (Yes vs. No)

    Participants will receive will receive 6 packs of NRT 2mg lozenge and written instructions to use the lozenge PRN to help manage acute nicotine withdrawal. Participants will be instructed to use the NRT lozenges no more than every 1-2 hours as needed. Participants will receive their study medications from their site coordinator on the day of their screening appointment or via mail from Arrowhead Promotion \& Fulfillment.

    Drug: Nicotine Lozenge · Other: saliva sample

  • Experimental
    Message Framing (Gain vs. Loss)

    Overall, a robust body of health communication literature demonstrates that gain-framed messages may be more effective than loss-framed or non-framed (neutral) messages for encouraging smoking cessation. In other words, quitting messages that promote smoking cessation are more persuasive if they emphasize the benefits of quitting (gain-framed) rather than the risks (loss-framed) of persistent smoking (25, 26). Included with the written communication of their LDCT-LCS results, participants will receive a printed individualized quitting message that emphasizes either the benefits of quitting (gain-framed) or the risks of continuing to smoke (loss-framed).

    Behavioral: Message Framing · Other: saliva sample

Interventions

  • BehavioralMotivational Interviewing (MI)

    two counseling sessions

  • DrugNicotine Replacement Therapy (NRT)

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

  • 6 packs of NRT 2mg lozenge

  • BehavioralMessage Framing

    health communication literature and quitting messages

  • Othersaliva sample

    saliva samples from those reporting abstinence and analyze samples

06

What researchers measure

Primary outcomes

  1. number of patients who are tobacco abstinence

    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.

    Time frame: 6 months following study enrollment

07

Study locations

18 sites
08

References and documents

Publications

  • Ostroff JS, Shelley DR, Chichester LA, King JC, Li Y, Schofield E, Ciupek A, Criswell A, Acharya R, Banerjee SC, Elkin EB, Lynch K, Weiner BJ, Orlow I, Martin CM, Chan SV, Frederico V, Camille P, Holland S, Kenney J. Study protocol of a multiphase optimization strategy trial (MOST) for delivery of smoking cessation treatment in lung cancer screening settings. Trials. 2022 Aug 17;23(1):664. doi: 10.1186/s13063-022-06568-3. PubMed 35978334 ↗
09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2017 (actual). Primary completion is estimated for Oct 2027, 120 months after the start.

Of 53 non-industry phase 4 interventional studies under Smoking Cessation, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 55. This study's planned 120 months is above that.

Counting every sponsor, half of 56 studies reached it within 35 months; a quarter within 21 and three quarters within 55.

Since we started tracking on Sep 25, 2026, the dates moved once, on Nov 3, 2026: primary completion Oct 2026 → Oct 2027 and completion Oct 2026 → Oct 2027.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Oct 17, 2017
First posted
Oct 20, 2017
StartActual
Oct 10, 2017
Primary completionEst.
Oct 2027was Oct 2026
CompletionEst.
Oct 2027was Oct 2026
Last update
Nov 3, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Primary completion
Oct 2026→Oct 2027
Nov 3, 2026
Study completion
Oct 2026→Oct 2027
Nov 3, 2026
Show all 1 update
  1. Nov 3, 2026
    Primary completion Oct 2026→Oct 2027
    Study completion Oct 2026→Oct 2027
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT03315910
Responsible party
Sponsor
First posted
Oct 20, 2017
Start date
Oct 10, 2017
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Nov 3, 2026

Study contacts

Jamie Ostroff, PhD
principal investigator · Memorial Sloan Kettering Cancer Center

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Nicotine Lozenge

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