Nicotine Products for Smoking Cessation

Recruiting at 1 trial location

Overseen By Perry Willette, M.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Rose Research Center, LLC

Must not be taking: Nicotine replacement, Chantix, Zyban

Disqualifiers: Pregnancy, Cannabis use, Medical conditions, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 4

Duration: 10-22 weeks

150 Participants Needed

Trial Summary

What is the purpose of this trial?

To determine whether smokers who initially respond (within 2 weeks) to nicotine products (including nicotine replacement therapy, e-cigarettes, nicotine pouches) by reducing their smoking by ≥50% can be successfully maintained on use of these noncombustible nicotine alternatives to cigarettes for 6 months, and whether this results in sustained smoking reduction/abstinence.

Do I have to stop taking my current medications to join the trial?

The trial requires that you have not used nicotine replacement therapies or prescription smoking cessation medications in the past 30 days. If you are currently using these, you would need to stop before joining the trial.

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

Research shows that nicotine replacement therapy (NRT), including nicotine gum, patches, and lozenges, can significantly increase the chances of quitting smoking. A meta-analysis found that using NRT increased the likelihood of quitting by 71% compared to not using any treatment. ^{1 2 3 4 5}

Is nicotine replacement therapy (NRT) safe for humans?

Research shows that nicotine replacement therapies like nicotine patches and gum are generally safe for humans, with no serious adverse events reported in studies. However, some concerns exist about potential cardiovascular risks, especially if not used as directed. ^{1 6 7 8 9}

How does this drug help with smoking cessation?

This treatment uses nicotine replacement therapy (NRT) products like patches, gum, and lozenges to help people quit smoking by providing a controlled dose of nicotine to ease withdrawal symptoms. The transdermal patch is noted for its superior pharmacokinetics (how the drug moves through the body) and fewer side effects compared to other forms, making it a preferred choice for many. ^{1 2 10 11 12}

Eligibility Criteria

This trial is for smokers who have managed to cut their smoking by at least half within two weeks using nicotine products. They should be aiming to maintain this reduction or quit smoking for six months. Specific eligibility criteria are not provided, so general health conditions and other factors that typically exclude participants from clinical trials may apply.

Inclusion Criteria

Screening eCO ≥ 10 ppm

Smoke cigarettes for ≥12 months prior to screening

Voluntarily provides consent for participation by signing the informed consent form (ICF)

Exclusion Criteria

I cannot read, speak, or understand English.

Cannabis Use Disorder Identification Test-Revised (CUDIT-R) score of 8 or greater

I do not have any major health or mental issues that could affect my safety or participation in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Initial Response Assessment

Participants' response to nicotine products is assessed by measuring expired carbon monoxide levels

2 weeks

1 visit (in-person)

Treatment

Participants who respond to nicotine products continue using their choice of nicotine products for either 10 or 22 additional weeks

10-22 weeks

Regular visits (in-person and virtual)

Follow-up

Participants are monitored for sustained smoking reduction/abstinence and nicotine product usage

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Nicoderm
• Nicorette 4Mg Chewing Gum
• Nicorette Lozenge Product
• NJOY e-cigarette

Trial Overview The study tests if smokers can keep up reduced smoking or stop entirely over six months using nicotine alternatives like patches (Nicoderm), lozenges (Nicorette), e-cigarettes (NJOY), gum (Nicorette Gum), and pouches (on!). It checks the adaptability of these products in maintaining long-term changes in smoking habits.

Participant Groups

Group I: Nicotine Responders - Group 2 Experimental Treatment 5 Interventions

Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 22 weeks (24-week total treatment period).

Group II: Nicotine Responders - Group 1 Experimental Treatment 5 Interventions

Participants that were successful in reducing their expired carbon monoxide by the end of week 2 will be randomized to continued use of their choice of nicotine products for an additional 10 weeks (12-week total treatment period).

Group III: Nicotine Non-Responders Experimental Treatment 5 Interventions

Participants that were not successful in reducing their expired carbon monoxide by the end of week 2 will not continue in the study.

Nicoderm is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Nicoderm for:

• Smoking cessation

Approved in European Union as Nicotinell for:

• Smoking cessation

Approved in Canada as Nicoderm for:

• Smoking cessation

Approved in Japan as Nicotrol for:

• Smoking cessation

Who Is Running the Clinical Trial?

Rose Research Center, LLC

Lead Sponsor

Trials

17

Recruited

1,600+

Global Action to End Smoking

Collaborator

Trials

1

Recruited

150+

Findings from Research

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]

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]

In a study of 642 smokers, transdermal nicotine showed a trend towards higher quit rates compared to nicotine lozenges, with 24.3% quitting at the end of treatment versus 18.7% for lozenges.

Smokers who preferred transdermal nicotine and did not use nicotine to manage emotional distress had better success rates, suggesting that individual preferences and reasons for smoking can influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. Schnoll, RA., Martinez, E., Tatum, KL., et al.[2022]

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]

The study successfully developed nicotine chewing gums (2 and 4 mg) with improved taste using aspartame as a sweetener and cherry and eucalyptus as flavoring agents, making them more acceptable to smokers.

These enhanced nicotine gums released 79-83% of their nicotine content within 20 minutes, indicating effective delivery of nicotine to support smoking cessation efforts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Design, formulation and evaluation of nicotine chewing gum. Aslani, A., Rafiei, S.[2021]

In a pharmacy-based study of 633 smokers using the OTC nicotine patch Nicotinell, 28% successfully quit smoking after 24 weeks, indicating the patch's effectiveness in promoting smoking cessation.

The study found no serious adverse events related to the nicotine patch, suggesting it is safe for use; however, only 62.9% of participants followed the recommended usage guidelines, highlighting a need for better compliance education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch. Cohort study on smoking cessation. Hasford, J., Fagerstrom, KO., Haustein, KO.[2018]

A study involving 47 patients demonstrated that nicotine-containing chewing gum 'Nicorette' was effective in treating nicotine dependence, achieving a positive outcome in 76.6% of cases.

The findings suggest that 'Nicorette' is a safe and effective option for long-term tobacco users and can help prevent relapse into nicotine dependence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Results of clinical use of nicotine chewing gum "Nicorette" in the practice of treating patients with psychological and behavior disorders caused by tobacco consumption]. Rebenok, AA., Korostiĭ, VI., Zhabokritskiĭ, SV., et al.[2018]

Nicotine replacement therapy (NRT) is an effective treatment for nicotine dependence, with various formulations available over-the-counter in several European countries.

The most commonly used NRT products, such as nicotine chewing gum and transdermal patches, have been proven safe and effective in population studies across different countries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy--method for smoking cessation]. Florek, E., Piekoszewski, W.[2017]

High-dose transdermal nicotine-replacement therapy (NRT) at doses of 42 mg or more daily appears to be safe, with most trials reporting no serious adverse events, although a dose-response relationship for adverse events was noted.

While high-dose NRT showed a numerically higher abstinence rate in most trials, none achieved statistically significant differences in final abstinence rates, indicating that more extensive studies are needed to confirm its efficacy and identify suitable patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High-dose transdermal nicotine replacement for tobacco cessation. Brokowski, L., Chen, J., Tanner, S.[2019]

Nicotine-replacement products, particularly transdermal nicotine patches, are effective in alleviating withdrawal symptoms during smoking cessation, making them a promising option for smokers trying to quit.

A review of recent clinical trials indicates that transdermal patches have superior pharmacokinetics and fewer side effects compared to nicotine gum, suggesting they may be the preferred method for nicotine replacement therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine-replacement products in smoking cessation: a review. Alsagoff, F., Lee, HP.[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]

In a study involving 935 healthy volunteers, a new transdermal nicotine system significantly improved smoking cessation rates, with 61% of participants using the 21 mg dose remaining abstinent during the last 4 weeks of treatment compared to only 27% in the placebo group.

The transdermal nicotine system not only increased cessation rates but also effectively reduced withdrawal symptoms and cigarette use among those who did not quit, with no serious adverse effects reported, indicating a safe and effective option for smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. [2016]

References

1. Germany pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

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

3. Ireland pubmed.ncbi.nlm.nih.gov

Nicotine patch vs. nicotine lozenge for smoking cessation: an effectiveness trial coordinated by the Community Clinical Oncology Program. [2022]

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

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

5. India pubmed.ncbi.nlm.nih.gov

Design, formulation and evaluation of nicotine chewing gum. [2021]

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

A naturalistic cohort study on effectiveness, safety and usage pattern of an over-the-counter nicotine patch. Cohort study on smoking cessation. [2018]

7. Ukraine pubmed.ncbi.nlm.nih.gov

[Results of clinical use of nicotine chewing gum "Nicorette" in the practice of treating patients with psychological and behavior disorders caused by tobacco consumption]. [2018]

8. Poland pubmed.ncbi.nlm.nih.gov

[Nicotine replacement therapy--method for smoking cessation]. [2017]

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

High-dose transdermal nicotine replacement for tobacco cessation. [2019]

10. India pubmed.ncbi.nlm.nih.gov

Nicotine-replacement products in smoking cessation: a review. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. [2015]

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

Transdermal nicotine for smoking cessation. Six-month results from two multicenter controlled clinical trials. Transdermal Nicotine Study Group. [2016]