Smoking CessationPhase 4NCT03315910
Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
A Phase 4 study testing Motivational Interviewing (MI), Nicotine Replacement Therapy (NRT) and Nicotine Lozenge in people with Smoking Cessation, run by Memorial Sloan Kettering Cancer Center at 18 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Motivational Interviewing (MI), Nicotine Replacement Therapy (NRT) and Nicotine Lozenge
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 807 participants
- Where
- 18 sitesUnited States
- Study dates
- 10 Oct 2017to Oct 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Rush University Medical Center
Chicago, Illinois, 606012
St. Mary Medical Center, Community Healthcare System
Crown Point, Indiana, 46307
MercyOne Des Moines Medical Center (Data Collection Only)
Des Moines, Iowa, 50314
Henry Ford Hospital (Data collection only)
Detroit, Michigan, 48202
Riverside Healthcare
Kankakee, Illinois, 60901
WellStar Health System
La Grange, Georgia, 30240
Fairfield Medical Center
Lancaster, Ohio, 43130
University of Southern California (Data Collection Only)
Los Angeles, California, 90033
NYU Winthrop Hospital
Mineola, New York, 11501
Carolinas Healthcare System Blue Ridge
Morganton, North Carolina, 28655
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Weill Cornell Medical Center
New York, New York, 10065
Temple University
Philadelphia, Pennsylvania, 19140
Legacy Health
Portland, Oregon, 97210
Maine Medical Center Cancer Institute
Scarborough, Maine, 04074
Montefiore Medical Center (Data Collection Only)
The Bronx, New York, 10467
Munson Healthcare
Traverse City, Michigan, 49684
John Muir Health
Walnut Creek, California, 94598
About this study
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.
- Conditions
- Smoking Cessation
- Being tested
- Motivational Interviewing (MI), Nicotine Replacement Therapy (NRT), Nicotine Lozenge, Message Framing, saliva sample
- Keywords
- Tobacco Treatment, Lung CT, Cancer Screening, 17-500
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational Interviewing (MI)Behavioural
two counseling sessions
Nicotine Replacement Therapy (NRT)Drug
receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day
Nicotine LozengeDrug
6 packs of NRT 2mg lozenge
Message FramingBehavioural
health communication literature and quitting messages
saliva sampleOther
saliva samples from those reporting abstinence and analyze samples
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing( MI) (Yes vs. No) | Experimental | 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. Receives: Behavioral: Motivational Interviewing (MI); Other: saliva sample |
| Nicotine Replacement Therapy (NRT) Patch (Yes vs. No) | Experimental | 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. Receives: Drug: Nicotine Replacement Therapy (NRT); Other: saliva sample |
| NRT Lozenge (Yes vs. No) | Experimental | 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. Receives: Drug: Nicotine Lozenge; Other: saliva sample |
| Message Framing (Gain vs. Loss) | Experimental | 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). Receives: Behavioral: Message Framing; Other: saliva sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2017
- Study start10 Oct 2017
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- The investigators have chosen to conduct a full factorial experimental design.
- Masking
- None (open label)
- Enrolment
- 807 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jamie Ostroff, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03315910
- Sponsor's protocol ID
- 17-500
- Status last verified
- Nov 2026
- First submitted
- 17 Oct 2017
- Last updated
- 3 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing Tobacco Treatment in Low Dose CT Lung Cancer Screening Sites
- ClinicalTrials.gov ID
- NCT03315910
- Acronym / sponsor ID
- 17-500
- Conditions
- Smoking Cessation
- Keywords
- Tobacco Treatment, Lung CT, Cancer Screening, 17-500
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 807 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 10 Oct 2017 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 20 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The investigators have chosen to conduct a full factorial experimental design.
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing( MI) (Yes vs. No) | Experimental | Behavioral: Motivational Interviewing (MI), Other: saliva sampleParticipants 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. |
| Nicotine Replacement Therapy (NRT) Patch (Yes vs. No) | Experimental | Drug: Nicotine Replacement Therapy (NRT), Other: saliva sampleParticipants 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. |
| NRT Lozenge (Yes vs. No) | Experimental | Drug: Nicotine Lozenge, Other: saliva sampleParticipants 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. |
| Message Framing (Gain vs. Loss) | Experimental | Behavioral: Message Framing, Other: saliva sampleOverall, 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). |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational Interviewing (MI)two counseling sessions | Behavioural | Motivational Interviewing( MI) (Yes vs. No) |
| Nicotine Replacement Therapy (NRT)receive 6 weeks of NRT patch with dosing dependent upon reported baseline cigarettes per day | Drug | Nicotine Replacement Therapy (NRT) Patch (Yes vs. No) |
| Nicotine Lozenge6 packs of NRT 2mg lozenge | Drug | NRT Lozenge (Yes vs. No) |
| Message Framinghealth communication literature and quitting messages | Behavioural | Message Framing (Gain vs. Loss) |
| saliva samplesaliva samples from those reporting abstinence and analyze samples | Other | Message Framing (Gain vs. Loss), Motivational Interviewing( MI) (Yes vs. No), NRT Lozenge (Yes vs. No), Nicotine Replacement Therapy (NRT) Patch (Yes vs. No) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Derived from this study: PubMed 35978334Ostroff 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie Ostroff, PhD principal investigator
Memorial Sloan Kettering Cancer Center
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Motivational Interviewing (MI), Nicotine Replacement Therapy (NRT) and Nicotine Lozenge in people with Smoking Cessation, run by Memorial Sloan Kettering Cancer Center at 18 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients who are tobacco abstinence (time frame: 6 months following study enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03315910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.