Nicotine Products for Smoking Cessation

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether smokers can switch to nicotine products, like patches or gum, to help them cut down or quit smoking permanently. The goal is to determine if individuals who reduce their smoking by at least half in the first two weeks can maintain this reduction for six months using non-cigarette nicotine options. Participants are divided into groups based on their initial success in reducing smoking. This trial suits those who have smoked at least 10 cigarettes a day for over a year and have not recently used nicotine replacements. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Previous studies have shown that nicotine patches, such as Nicoderm, help people quit smoking by reducing withdrawal symptoms. However, they can cause side effects, especially around children, so following safety guidelines is important. Research shows that nicotine gum, like Nicorette 4Mg, aids in quitting smoking, but incorrect use can lead to nicotine poisoning. Only smokers trying to quit should use the gum.

Studies suggest that nicotine lozenges are safe and effective for quitting smoking, but they should not be used during pregnancy due to nicotine exposure risks. E-cigarettes have been found to help people stop smoking, although safety data is still being collected. The FDA has approved some e-cigarette products, indicating they are considered safer than traditional cigarettes.

Overall, these nicotine replacement products are generally well-tolerated, but using them as directed is crucial to avoid potential risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these nicotine products for smoking cessation because they offer a personalized approach to quitting smoking. Unlike traditional methods that often involve a one-size-fits-all nicotine replacement therapy, this trial allows participants to choose from various options like Nicoderm patches, Nicorette gum, or Nicorette lozenges. This flexibility can help meet individual preferences and needs, potentially increasing the chances of successfully quitting smoking. Additionally, the trial explores the effectiveness of extending treatment duration, which might provide more comprehensive support for those struggling to quit. This unique approach could lead to more tailored and effective smoking cessation strategies.

What evidence suggests that this trial's treatments could be effective for smoking cessation?

Research shows that nicotine replacement therapies (NRTs) like Nicoderm patches, Nicorette gum, and Nicorette lozenges can help people quit smoking. In this trial, participants who successfully reduce their expired carbon monoxide by the end of week 2 will continue using their choice of these nicotine products. Studies indicate that people using Nicoderm patches are more than twice as likely to quit compared to those using a placebo. While Nicorette gum is effective, it generally has slightly lower success rates than patches but still helps many people stop smoking. Nicorette lozenges have shown promising results, sometimes achieving better quit rates than the gum. Overall, these nicotine products offer a safer alternative to smoking, aiding many in reducing or quitting smoking altogether. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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

I am between 22 and 65 years old.

Smoke cigarettes for ≥12 months prior to screening

Screening eCO ≥ 10 ppm

Exclusion Criteria

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.

I cannot read, speak, or understand English.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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]

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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2772963X25002522

The Effect of 12-Week e-Cigarette Use on Smoking ... Our results showed that even short-term use of e-cigarettes leads to greater smoking cessation at 52 weeks compared to counseling alone. e-Cigarettes are a ...

2. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(23)00319-X/fulltext

Effect of unguided e-cigarette provision on uptake, use, ... We aimed to determine the naturalistic uptake, use, and impact of e-cigarettes among adults who may or may not want to stop smoking.

3. systematicreviewsjournal.biomedcentral.com systematicreviewsjournal.biomedcentral.com/articles/10.1186/s13643-024-02572-7

Effectiveness of e-cigarettes as a stop smoking intervention in ... This systematic review aims to identify the benefits and harms of electronic cigarettes (e-cigarettes) as a smoking cessation aid in adults (aged ≥ 18 years)

4. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03453385

Clinical Outcomes of a Nationwide, Naturalistic E-Cig Trial ... We are testing the effects of one specific ecigarette (NJoy) on naturalistic changes in smoking behavior. Neither the tobacco industry nor any ecigarette ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7171267/

Electronic Cigarette Use and Cigarette Abstinence Over 2 ... In multivariable-adjusted analyses, daily e-cigarette use at Wave 1 was associated with higher odds of prolonged cigarette smoking abstinence at Waves 2 and 3 ...

6. amjmed.com amjmed.com/article/S0002-9343(23)00295-4/fulltext

Efficacy and Safety of E-Cigarette Use for Smoking Cessation Although currently available safety data are inconclusive, e-cigarettes may be considered for smoking cessation given the established long-term ...

7. fda.gov fda.gov/news-events/press-announcements/fda-authorizes-marketing-four-menthol-flavored-e-cigarette-products-after-extensive-scientific

FDA Authorizes Marketing of Four Menthol-Flavored E ... The FDA issued marketing granted orders to NJOY LLC for four menthol-flavored e-cigarette products – NJOY ACE Pod Menthol 2.4%, NJOY ACE Pod ...

8. bhwellness.org bhwellness.org/fact-sheets-reports/BHWP%20E-Cigarette%20Facts%20and%20Recommendations.pdf

E-cigarette Facts and Recommendations Because there is no combustion of tobacco, e- cigarettes are marketed as being a safer alternative to cigarettes and as a product allowing people to 'smoke' in ...