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Tobacco Treatment for Smoking Cessation
Phase 4
Waitlist Available
Led By Jamie Ostroff, PhD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Site must be designated as an American College of Radiology (ACR) designated lung cancer screening site
Site Coordinator must be employed as a full-time Site Coordinator at participating lung cancer screening site
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months following study enrollment
Awards & highlights
Study Summary
This trial is testing different ways to help smokers reduce the number of cigarettes they smoke or quit smoking, to see which is most effective. The goal is to increase the benefits of lung cancer screening by making it easier for patients to quit smoking.
Who is the study for?
This trial is for smokers aged 50-80 who are getting lung cancer screening at sites with certain qualifications. They must smoke currently, be reachable by phone, and speak English or Spanish. Smokers can't join if they've had a recent heart attack, unstable angina, or used tobacco treatments in the past month.Check my eligibility
What is being tested?
The study tests different ways to help smokers quit as part of lung cancer screening programs. It includes message framing techniques, nicotine lozenges, motivational interviewing (MI), nicotine replacement therapy (NRT), and saliva sampling to find the best method without overburdening staff.See study design
What are the potential side effects?
Possible side effects from interventions like NRT may include irritation where the product is applied, sleep problems (especially with patches), indigestion, dizziness and headaches.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My treatment center is recognized for lung cancer screening.
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I am a full-time Site Coordinator at a lung cancer screening site.
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I am between 50 and 80 years old.
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I am looking to get my first or yearly low-dose CT scan for lung cancer.
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I have smoked cigarettes in the last 30 days.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months following study enrollment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months following study enrollment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
number of patients who are tobacco abstinence
Trial Design
4Treatment groups
Experimental Treatment
Group I: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)Experimental Treatment2 Interventions
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.
Group II: NRT Lozenge (Yes vs. No)Experimental Treatment2 Interventions
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.
Group III: Motivational Interviewing( MI) (Yes vs. No)Experimental Treatment2 Interventions
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.
Group IV: Message Framing (Gain vs. Loss)Experimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nicotine Lozenge
2005
Completed Phase 4
~300
Motivational Interviewing (MI)
2010
Completed Phase 3
~2830
Nicotine Replacement Therapy (NRT)
2017
Completed Phase 4
~6890
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,952,556 Total Patients Enrolled
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,940 Previous Clinical Trials
588,104 Total Patients Enrolled
Jamie Ostroff, PhDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
16 Previous Clinical Trials
5,539 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50 and 80 years old.I have smoked cigarettes in the last 30 days.I work full-time as a Site Coordinator at a lung cancer screening site.I work full-time as a Site Coordinator at a lung cancer screening center.I am looking for my first or yearly low-dose CT scan for lung cancer.You have smoked at least one pack of cigarettes per day for 20 years or more.I can be contacted by phone.My care facility has over a year of experience in lung cancer screening.I can be contacted by phone.I speak either English or Spanish.I believe I meet the study's requirements based on my own assessment.I have smoked cigarettes in the last 30 days.I cannot use nicotine replacement therapy due to a recent heart issue.I am a smoker using cessation aids or services within the last month.My treatment center is recognized for lung cancer screening.I am a full-time Site Coordinator at a lung cancer screening site.I am looking to get my first or yearly low-dose CT scan for lung cancer.You are a self-reported user of the site.I am between 50 and 80 years old.You are eligible if you have conducted at least 20 new initial screenings per month as a Site Coordinator.I speak English or Spanish.
Research Study Groups:
This trial has the following groups:- Group 1: Motivational Interviewing( MI) (Yes vs. No)
- Group 2: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)
- Group 3: NRT Lozenge (Yes vs. No)
- Group 4: Message Framing (Gain vs. Loss)
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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