Nicotine Pouches + Lozenges for Smoking Cessation

Overseen By Megan Piper, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Wisconsin, Madison

Must not be taking: Bupropion

Disqualifiers: Psychosis, Bipolar, Pregnant, 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: 7

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if nicotine pouches and mini lozenges can help people switch from smoking cigarettes to using these alternative nicotine products. Participants will use either nicotine pouches, mini lozenges, or no product to identify which aids most in quitting smoking. This trial may suit individuals who have smoked at least 5 cigarettes a day for the last 6 months and do not plan to quit smoking in the next 30 days. As a Phase 4 trial, this research focuses on understanding how these FDA-approved treatments can benefit more patients.

Will I have to stop taking my current medications?

If you are using nicotine replacement, varenicline, or bupropion (only for smoking cessation), you will need to stop taking them to participate in the trial. If you are taking bupropion for other reasons, like depression, you cannot join the trial.

What is the safety track record for nicotine pouches and mini nicotine lozenges?

A previous study found that mini nicotine lozenges were generally well tolerated. People often use them to quit smoking by easing cravings and withdrawal symptoms. Users should follow the recommended dosage to avoid problems.

Research has shown that the FDA has approved nicotine pouches for marketing, indicating they have undergone some safety checks. However, like all nicotine products, they can be addictive and are not completely risk-free.

Overall, both treatments are generally well tolerated but come with the usual risks of using nicotine. Participants should consider these risks and potential benefits when deciding whether to join the trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about these treatments for smoking cessation because they offer unique delivery methods that differ from traditional options like nicotine patches, gums, or prescription medications. Nicotine pouches and mini lozenges deliver nicotine orally, which can provide a more convenient and discreet way for smokers to manage cravings without the need for smoking or using cumbersome devices. Additionally, these treatments allow for flexible dosing, which can be tailored to individual needs based on their smoking habits, potentially enhancing effectiveness and user satisfaction. These features aim to provide smokers with new tools to help quit smoking, offering alternatives to those who may have struggled with or prefer not to use existing methods.

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

This trial will evaluate the effectiveness of different nicotine replacement therapies for smoking cessation. Participants may receive either 3mg or 6mg nicotine pouches, which research has shown can help reduce cigarette consumption. In one study, 41% of users reported quitting smoking, while 38.1% successfully reduced their smoking. However, strong evidence does not yet support nicotine pouches as a safe or effective method for complete smoking cessation. Another group in this trial will use nicotine mini lozenges, which have shown promising results in studies. These lozenges can significantly aid smoking cessation by providing a controlled amount of nicotine to manage cravings and withdrawal symptoms. ^{6 7 8 9 10}

Who Is on the Research Team?

Megan Piper, PhD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

This trial is for individuals who are currently smoking and interested in quitting. Participants will try nicotine pouches or mini lozenges as alternatives to cigarettes. They must be willing to attend several research visits, complete questionnaires, and use a smartphone app to track their usage of products.

Inclusion Criteria

I am 21 years old or older.

Exhaled carbon monoxide ≥ 6 ppm

I haven't used nicotine pouches or smokeless tobacco in the last 6 months.

Exclusion Criteria

I am currently taking bupropion for reasons other than to quit smoking.

Currently pregnant or breastfeeding

I am currently being treated for psychosis or bipolar disorder.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Product Use and Switching

Participants use nicotine pouches, mini lozenges, or no product for 1 week, then attempt to abstain from smoking for 3 weeks

4 weeks

6 in-person visits

Follow-up

Participants are monitored for safety and effectiveness after the switching period

1 week

1 follow-up call

What Are the Treatments Tested in This Trial?

Interventions

• Mini Nicotine lozenges
• Nicotine Pouches

Trial Overview The study is testing the effectiveness of nicotine pouches and mini lozenges in helping smokers quit by substituting these products for cigarettes. Over a four-week period, participants will first use one of the products for a week followed by an attempt to abstain from smoking for three weeks.

How Is the Trial Designed?

Group I: Nicotine Mini Lozenges Experimental Treatment 1 Intervention

Participants will use mini lozenges with dosing based on time to first cigarette (2mg - 4mg)

Group II: 6mg Nicotine Pouches Experimental Treatment 1 Intervention

Participants will use 6mg nicotine pouches

Group III: 3mg Nicotine Pouches Experimental Treatment 1 Intervention

Participants will use 3mg nicotine pouches

Group IV: No Study Product Active Control 1 Intervention

Participants randomized to this arm will use a mint candy during two different 30-minute laboratory sessions only.

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

A study analyzing 653 Reddit posts about oral nicotine pouches revealed that users predominantly shared positive experiences and product information, indicating a favorable public perception of these tobacco-free products.

The discussions also highlighted a significant interest in quitting traditional nicotine products, with 12.7% of posts focused on using oral nicotine pouches as a cessation tool, suggesting potential for these pouches in harm reduction strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceptions of Oral Nicotine Pouches on Reddit: Observational Study. Shao, Y., Zou, J., Xie, Z., et al.[2022]

Nicotine pouch use in Great Britain is currently rare, with a prevalence of only 0.26% among adults, but it has doubled from November 2020 to October 2021, indicating a growing interest in these products.

The use of nicotine pouches is significantly more common among men, current smokers, and users of other nicotine products like e-cigarettes and nicotine replacement therapies, suggesting that these pouches may appeal more to those already familiar with nicotine consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tobacco-free Nicotine Pouch Use in Great Britain: A Representative Population Survey 2020-2021. Tattan-Birch, H., Jackson, SE., Dockrell, M., et al.[2022]

The novel tobacco-free nicotine pouch, ZYN, delivers nicotine effectively, with the 6 mg and 8 mg doses providing similar or faster nicotine absorption compared to traditional smokeless products like General snus and Longhorn moist snuff.

ZYN products showed a higher extraction fraction of nicotine (50-59%) compared to General snus (32%) and Longhorn moist snuff (19%), indicating a more efficient delivery of nicotine without significant adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetic Comparison of a Novel Non-tobacco-Based Nicotine Pouch (ZYN) With Conventional, Tobacco-Based Swedish Snus and American Moist Snuff. Lunell, E., Fagerström, K., Hughes, J., et al.[2021]

A study analyzing nicotine pouch advertising from January 2019 to September 2021 found that Zyn and Velo dominated the market, accounting for 44.4% and 52.8% of 286 unique ads, respectively, with a total expenditure of nearly $24.8 million, primarily on radio and television.

The advertising themes heavily emphasized 'freedom' and 'flavour', with Zyn focusing on brand identity and Velo on innovation, highlighting the need for regulatory oversight to understand the impact of these marketing strategies on consumers, especially young people.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine pouch marketing strategies in the USA: an analysis of Zyn, On! and Velo. Duan, Z., Henriksen, L., Vallone, D., et al.[2022]

ZYN nicotine pouches contain no nitrosamines or polycyclic aromatic hydrocarbons (PAHs), indicating a potentially lower risk profile compared to traditional tobacco products, which often contain harmful constituents.

The levels of harmful and potentially harmful constituents (HPHCs) in ZYN were found to be similar to those in nicotine replacement therapy (NRT) products, suggesting that ZYN may be a safer alternative for nicotine delivery compared to moist snuff, which had significantly higher levels of harmful compounds.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Harmful and potentially harmful constituents (HPHCs) in two novel nicotine pouch products in comparison with regular smokeless tobacco products and pharmaceutical nicotine replacement therapy products (NRTs). Back, S., Masser, AE., Rutqvist, LE., et al.[2023]

Nicotine pouches are gaining popularity in the UK as tobacco-free products that deliver nicotine when placed between the lip and gum.

The article discusses the composition, legality, and usage patterns of nicotine pouches, as well as potential oral and general health effects associated with their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nicotine pouches: a review for the dental team. M Jackson, J., Weke, A., Holliday, R.[2023]

Lucy, a company producing flavored nicotine products, may mislead consumers by marketing its gums, lozenges, and pouches in a way that confuses smoking cessation products with those that maintain nicotine dependence, particularly since only the lozenges are FDA approved for cessation.

The attractive packaging and marketing strategies, which emphasize flavors and downplay nicotine warnings, could appeal to youth and non-users, potentially increasing nicotine initiation rather than promoting cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lucy-Novel Flavored Nicotine Gum, Lozenges, and Pouches: Are They Misleading Consumers? Unger, JB., Barker, J., Cruz, TB., et al.[2023]

In a study involving 63 smokers, both snus and Zonnic were preferred over nicotine gum, showing greater effectiveness in reducing smoking urges and causing fewer side effects.

Participants experienced significant reductions in smoking (33% for gum, 37% for snus, and 42% for Zonnic), indicating that snus and Zonnic could be promising alternatives for nicotine replacement therapy, warranting further research on their long-term effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized crossover trial of the acceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. Caldwell, B., Burgess, C., Crane, J.[2022]

Citations

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Nicorette mini Lozenges Safety Information The Nicorette mini Lozenge was generally well tolerated1​​ The safety of Nicorette mini Lozenge was evaluated in a single-center, single-dose, double-blind, ...

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SAFETY DATA SHEET Do not induce vomiting without advice from poison control center. Ingestion. SDS UK. Material name: NICORETTE & NICOBATE MINI LOZENGES, 2MG & ...

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Label: MINI NICOTINE- nicotine polacrilex lozenge - DailyMed TO INCREASE YOUR SUCCESS IN QUITTING: 1. You must be motivated to quit. 2.Use Enough - Use at least 9 Nicotine mini lozenges per day during the first six weeks.