Tobacco Treatment for Smoking Cessation

Recruiting at 18 trial locations

Overseen By Jeffrey Schneider, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Memorial Sloan Kettering Cancer Center

Must not be taking: NRT, Bupropion, Varenicline

Disqualifiers: Recent heart attack, Unstable angina, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6-8 weeks

807 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{11 12 13 14 15}

Research Team

Jamie Ostroff, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Eligibility Criteria

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.

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

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

Treatment Details

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.

Participant Groups

Group I: Nicotine Replacement Therapy (NRT) Patch (Yes vs. No) Experimental Treatment 2 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 Treatment 2 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 Treatment 2 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 Treatment 2 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).

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. Cole, S., Suter, C., Nash, C., et al.[2019]

Nicotinell lozenges, particularly the 1 mg formulation, have been shown to be bioequivalent to 2 mg nicotine gum, providing effective nicotine delivery for smoking cessation, with significant short-term efficacy demonstrated in over 900 smokers.

The lozenges have an excellent safety profile, with only mild and reversible adverse events reported, making them a safe option for smokers seeking to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). Dautzenberg, B., Nides, M., Kienzler, JL., et al.[2023]

The study found that three prototype 4-mg nicotine lozenges produced in India were bioequivalent to the globally marketed Nicorette® 4-mg lozenge, indicating they can effectively deliver similar levels of nicotine to the bloodstream.

All prototype lozenges were well tolerated and had safety profiles comparable to the reference product, suggesting they are a safe alternative for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . Sukhija, M., Srivastava, R., Kaushik, A.[2018]

Medicinal nicotine has significantly improved smoking cessation rates over the past 20 years, with various products like patches, gum, and inhalers available to help smokers quit.

Innovative nicotine delivery methods, such as high-dose patches and new forms like drinks and lollipops, are being developed to enhance cessation success and manage withdrawal symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. Shiffman, S., Fant, RV., Buchhalter, AR., et al.[2015]

The prototype mini lozenge for nicotine replacement therapy (NRT) was found to be bioequivalent to a commercially available mini lozenge, showing no significant differences in key pharmacokinetic parameters such as maximum plasma nicotine concentration and overall nicotine absorption.

The most common side effect reported was mild throat irritation, with no serious adverse events, indicating that the new lozenge is a safe option for smokers seeking to manage withdrawal symptoms during their quit attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Characterization of a Prototype Mini Nicotine Lozenge. Lai, PM., Araga, M., Hamilton, A., et al.[2022]

In a study of 33,690 smokers using nicotine replacement therapy (NRT) through the New York State Smokers' Quitline, about 25% reported adverse effects at 2 weeks, which increased to 42% at 3 months, but most effects were mild.

Only a small percentage (4.4%-5.4%) discontinued NRT due to these adverse effects, indicating that NRT is generally safe for users when proper screening is conducted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. Ossip, DJ., Abrams, SM., Mahoney, MC., et al.[2015]

A meta-analysis of 53 randomized controlled trials involving 17,703 subjects found that nicotine-replacement therapy (NRT) significantly increases the odds of smoking abstinence, with an overall odds ratio of 1.71 compared to control groups.

Different forms of NRT showed varying effectiveness, with inhaled nicotine being the most effective (odds ratio of 3.05), while the effectiveness was largely independent of the level of nicotine dependence and the intensity of additional support provided.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. Silagy, C., Mant, D., Fowler, G., et al.[2019]

Motivational interviewing (MI) significantly improved long-term smoking cessation rates in nonpregnant individuals, showing a 2.3% higher abstinence rate compared to other interventions, based on a meta-analysis of 31 controlled trials.

The effectiveness of MI was particularly notable in specific subgroups, such as younger participants and those with lower motivation to quit, while effects were smaller in pregnant individuals, suggesting tailored approaches may enhance outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Motivational interviewing for smoking cessation: a meta-analytic review. Hettema, JE., Hendricks, PS.[2022]

Motivational interviewing (MI) showed some effectiveness in reducing the number of cigarettes smoked per day among adolescents, with significant decreases reported at the 1-month follow-up, although overall abstinence rates were low and did not differ significantly from brief advice (BA).

MI was effective in changing adolescents' perceptions of peer and adult smoking norms, which could be beneficial for future smoking interventions, but it did not lead to higher motivation or self-efficacy to quit smoking compared to BA.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced motivational interviewing versus brief advice for adolescent smoking cessation: results from a randomized clinical trial. Colby, SM., Nargiso, J., Tevyaw, TO., et al.[2022]

Combining counseling techniques like Motivational Interviewing (MI) and Cognitive Behavioral Therapy (CBT) with medication is crucial for effective smoking cessation, as MI helps those reluctant to quit and CBT supports those who want to quit but struggle.

Despite their proven effectiveness in the U.S. for various groups, including those with depression or weight concerns, MI and CBT are not widely practiced in Japan, highlighting a gap in smoking cessation treatment that could be addressed by healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Motivational interviewing and cognitive behavior therapy for smoking cessation]. Kawai, A., Kano, M., Sato, T.[2022]

References

1. India pubmed.ncbi.nlm.nih.gov

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]

2. United States pubmed.ncbi.nlm.nih.gov

The effectiveness of nicotine replacement therapies in smoking cessation. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of a Temporary NRT Enhancement in a State Quitline and Web-Based Program. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, safety and efficacy from randomized controlled trials of 1 and 2 mg nicotine bitartrate lozenges (Nicotinell). [2023]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Nicotine replacement therapies: patient safety and persistence. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

Pharmacokinetic characterization of three novel 4-mg nicotine lozenges . [2018]

7. England pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. [2015]

8. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Characterization of a Prototype Mini Nicotine Lozenge. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Adverse effects with use of nicotine replacement therapy among quitline clients. [2015]

10. England pubmed.ncbi.nlm.nih.gov

Meta-analysis on efficacy of nicotine replacement therapies in smoking cessation. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Motivational interviewing for smoking cessation: a meta-analytic review. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Enhanced motivational interviewing versus brief advice for adolescent smoking cessation: results from a randomized clinical trial. [2022]

13. Japan pubmed.ncbi.nlm.nih.gov

[Motivational interviewing and cognitive behavior therapy for smoking cessation]. [2022]

14. United States pubmed.ncbi.nlm.nih.gov

An updated algorithm for choosing among smoking cessation treatments. [2018]

15. Australia pubmed.ncbi.nlm.nih.gov

A summary of the recommendations for smoking cessation interventions: the quality assurance in the treatment of drug dependence project. [2006]