807 Participants Needed

Tobacco Treatment for Smoking Cessation

Recruiting at 18 trial locations
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Overseen ByMichaela Straznicka, MD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Memorial Sloan Kettering Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that you have not used any smoking cessation medications like nicotine replacement therapy (NRT), bupropion, or varenicline in the past month. If you are currently using these, you would need to stop before participating.

Is nicotine replacement therapy (NRT) safe for humans?

Nicotine replacement therapy (NRT), which includes products like nicotine patches, gum, lozenges, and inhalers, has been used for over 20 years to help people quit smoking. While it is effective in increasing quit rates, there is limited systematic data on adverse effects and safety, especially among users of quitline services.12345

How does motivational interviewing differ from other smoking cessation treatments?

Motivational interviewing (MI) is unique because it focuses on enhancing a person's motivation to quit smoking, especially for those not currently interested in quitting. Unlike other treatments that may rely heavily on medication, MI uses a conversational approach to help individuals explore their own reasons for change.678910

What data supports the effectiveness of the treatment for smoking cessation?

Research shows that nicotine replacement therapies (NRTs), like gum, patches, and lozenges, can nearly double the chances of quitting smoking successfully. These treatments are most effective when combined with additional support and advice.1112131415

Who Is on the Research Team?

Jamie S. Ostroff, PhD - MSK Psychologist

Jamie Ostroff, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 50 and 80 years old.
Patient must have at least a 20 pack-year history of smoking
I have smoked cigarettes in the last 30 days.
See 6 more

Exclusion Criteria

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person or virtual)

Treatment

Participants receive motivational interviewing sessions and nicotine replacement therapy

6-8 weeks
2 visits (in-person or virtual), additional follow-ups via telephone

Follow-up

Participants are monitored for smoking cessation and biochemical verification of abstinence

6 months
Biochemical verification via mailed salivary cotinine assay

What Are the Treatments Tested in This Trial?

Interventions

  • Message Framing
  • Motivational Interviewing (MI)
  • Nicotine Lozenge
  • Nicotine Replacement Therapy (NRT)
  • saliva sample
Trial Overview 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.
How Is the Trial Designed?
4Treatment groups
Experimental Treatment
Group I: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No)Experimental Treatment2 Interventions
Group II: NRT Lozenge (Yes vs. No)Experimental Treatment2 Interventions
Group III: Motivational Interviewing( MI) (Yes vs. No)Experimental Treatment2 Interventions
Group IV: Message Framing (Gain vs. Loss)Experimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a study of 72 smokers over 12 weeks, nicotine patches were found to be more effective than nicotine gum for smoking cessation, with higher quit rates and better adherence among participants.
Salivary cotinine levels, which were measured to assess nicotine intake, showed a significant reduction in the patch group compared to the gum group, indicating that patches may provide a more reliable method for nicotine replacement therapy.
Comparative evaluation of the efficacy of nicotine chewing gum and nicotine patches as nicotine replacement therapy using salivary cotinine levels as a biochemical validation measure.Sivasankari, T., Sankaran, A., Murugappan, S., et al.[2023]
Nicotine replacement therapies (NRTs) significantly increase the chances of quitting smoking, with an overall odds ratio of 1.71 based on a review of 53 trials involving 17,703 patients.
Among different NRT forms, the transdermal patch and inhaled nicotine showed the highest effectiveness, with odds ratios of 2.07 and 3.05 respectively, indicating that these methods may be particularly beneficial for smokers trying to quit.
The effectiveness of nicotine replacement therapies in smoking cessation.Silagy, C., Mant, D., Fowler, G., et al.[2019]
Participants receiving an 8-week nicotine replacement therapy (NRT) had significantly higher quit rates (42.5%) compared to those receiving a 4-week NRT (33.3%), indicating that longer NRT duration enhances cessation success.
Among participants in a multiple-call program, those who received both 4-week NRT shipments had a quit rate of 51.1%, compared to 31.1% for those who only received one shipment, suggesting that consistent support and extended NRT can improve outcomes.
Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program.Cole, S., Suter, C., Nash, C., et al.[2019]

Citations

Comparative evaluation of the efficacy of nicotine chewing gum and nicotine patches as nicotine replacement therapy using salivary cotinine levels as a biochemical validation measure. [2023]
The effectiveness of nicotine replacement therapies in smoking cessation. [2019]
Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]
Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]
Nicotine replacement therapies: patient safety and persistence. [2021]
Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . [2018]
Nicotine delivery systems. [2015]
Pharmacokinetic Characterization of a Prototype Mini Nicotine Lozenge. [2022]
Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]
Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. [2019]
11.United Statespubmed.ncbi.nlm.nih.gov
Motivational interviewing for smoking cessation: a meta-analytic review. [2022]
Enhanced motivational interviewing versus brief advice for adolescent smoking cessation: results from a randomized clinical trial. [2022]
[Motivational interviewing and cognitive behavior therapy for smoking cessation]. [2022]
14.United Statespubmed.ncbi.nlm.nih.gov
An updated algorithm for choosing among smoking cessation treatments. [2018]
A summary of the recommendations for smoking cessation interventions: the quality assurance in the treatment of drug dependence project. [2006]
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