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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

Must not have

NRT is medically contraindicated (e.g., recent heart attack within the last 2 weeks or unstable/worsening angina)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months following study enrollment

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use nicotine replacement therapy due to a recent heart issue.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months following study enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

number of patients who are tobacco abstinence

Awards & Highlights

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.

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