Nicotine Pouches for Smoking Cessation

(Pack2Pouch Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Amanda Palmer

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Medical University of South Carolina

Must not be taking: Smoking cessation medications

Disqualifiers: Non-cigarette tobacco, Marijuana, Pregnancy, others

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

Tobacco-free oral nicotine pouches (such as Zyn brand) are a less harmful alternative to cigarette smoking. Pouches, however, contain nicotine, and addictive substance that is not risk-free. The present study is evaluating how well nicotine pouches, at different nicotine levels, help people switch away from smoking cigarettes. People who smoke cigarettes will be asked to answer questions about their tobacco product use and provide breath samples and cheek swab samples at an in-person visit to MUSC Charleston. Participants will then be provided with a 28-day supply of nicotine pouches, and will be asked to switch from smoking to pouches over the course of 4 weeks. Finally, participants will complete a final visit at MUSC, and will answer more questions about their tobacco use 1-month later.

Will I have to stop taking my current medications?

If you are currently using smoking cessation medications like varenicline, bupropion, or nicotine replacement therapy, you will need to stop taking them to participate in this trial.

What data supports the effectiveness of nicotine pouches as a treatment for smoking cessation?

Research suggests that nicotine pouches, like Zonnic, can help reduce withdrawal symptoms and are considered a low-risk alternative to cigarettes. They may be as effective as other nicotine replacement therapies, such as gum, in helping people quit smoking. ^{1 2 3 4 5}

Is there any safety data available for nicotine pouches used in smoking cessation?

There is limited safety data on nicotine pouches, but they are considered a low-risk alternative to cigarettes and traditional smokeless tobacco. However, more research is needed to fully understand their health impacts. ^{1 6 7 8 9}

How do nicotine pouches differ from other smoking cessation treatments?

Nicotine pouches are a novel, tobacco-free oral product that provides nicotine without the harmful chemicals found in traditional tobacco products, making them a potentially lower-risk alternative for smokers. Unlike nicotine gum or patches, these pouches are discreet and do not require chewing or sticking to the skin, offering a different method of nicotine delivery. ^{1 4 5 6 8}

Eligibility Criteria

This trial is for individuals who are currently cigarette smokers and want to switch to a less harmful alternative. Participants will be asked to use tobacco-free nicotine pouches with varying nicotine levels over 4 weeks, provide breath and cheek swab samples, and answer questions about their tobacco use.

Inclusion Criteria

Have internet access

I have used TNF blockers less than 5 times in my life.

I can go to Charleston for 2 visits to check my health markers.

Exclusion Criteria

Lack of proficiency in English

Use of marijuana within the past month, and unwillingness to abstain from marijuana during the course of the study

I have used tobacco products or e-cigarettes in the last 30 days.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a 28-day supply of nicotine pouches and are asked to switch from smoking to pouches over 4 weeks

4 weeks

1 visit (in-person), daily surveys

Follow-up

Participants are monitored for smoking reduction and switching to nicotine pouches

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Nicotine Pouches (Nicotine Replacement Therapy)

Trial Overview The study is testing the effectiveness of low versus high nicotine dose in tobacco-free oral nicotine pouches at helping cigarette smokers switch away from smoking. It involves an initial visit, a month-long period using the provided pouches, followed by a final visit and additional follow-up.

Participant Groups

Group I: Low Nicotine Experimental Treatment 1 Intervention

Low dosage nicotine pouches (3mg)

Group II: High Nicotine Experimental Treatment 1 Intervention

High dosage nicotine pouches (6mg)

Nicotine Pouches is already approved in United States, European Union for the following indications:

🇺🇸 Approved in United States as Nicotine Pouches for:

• Smoking cessation aid
• Nicotine replacement therapy

🇪🇺 Approved in European Union as Nicotine Pouches for:

• Smoking cessation aid
• Nicotine replacement therapy

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Medical University of South Caroloina Charleston, SC

Medical University of South Carolina Charleston, SC

Who Is Running the Clinical Trial?

Medical University of South Carolina Lead Sponsor

National Institute on Drug Abuse (NIDA) Collaborator

References

1. Switzerland 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). [2023] Tobacco-free nicotine pouches is a novel category of oral nicotine-delivery products. Among current tobacco users such pouches may serve as a low-risk alternative to cigarettes or conventional, tobacco-based oral products e.g., snus and moist snuff. In the United States (U.S.), the market leading nicotine-pouch brand is ZYN®. However, no data on the chemical characteristics of ZYN have been published.

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

Randomized crossover trial of the acceptability of snus, nicotine gum, and Zonnic therapy for smoking reduction in heavy smokers. [2022] Novel approaches to nicotine replacement therapy (NRT) are needed to improve the modest long-term quit rate of 10%. Snus (Swedish tobacco) and Zonnic (oral nicotine sachet) rapidly deliver nicotine via buccal absorption and have potential as NRTs. As a prelude to formal evaluation of either product as a smoking cessation therapy, it is necessary to determine their acceptability and the willingness of smokers to use them in populations with no history of access to oral tobacco products.

3. England pubmed.ncbi.nlm.nih.gov

Nicotine delivery systems. [2015] Over the past 20 years, medicinal nicotine has been used to aid smoking cessation, and has led to a significant increase in the number of smokers who successfully quit. This review describes currently available medicinal nicotine products, which include nicotine patch, gum, lozenge, nasal spray, inhaler and sublingual tablet, including their pharmacokinetics and recommended dosing. New developments in nicotine delivery that could further increase cessation rates include high-dose patches, rapid release gum, combined patch and acute forms, and several novel channels for nicotine delivery, such as nicotine drink, straw, lollipop and a pulmonary inhaler. New applications of existing and novel medicinal nicotine products may include relapse prevention, nicotine maintenance, temporary withdrawal management, reduced smoking and gradual quitting.

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

A single-blind, randomized, crossover trial of the effects of a nicotine pouch on the relief of tobacco withdrawal symptoms and user satisfaction. [2015] We compared the effects of a 4-mg oral nicotine pouch (Zonnic pouch), with nicotine chewing gum and placebo pouch, on withdrawal discomfort after overnight tobacco abstinence. We also assessed participants' preferences, satisfaction, and consumption patterns.

5. England pubmed.ncbi.nlm.nih.gov

Use, marketing, and appeal of oral nicotine products among adolescents, young adults, and adults. [2023] Oral nicotine products such as pouches, lozenges, tablets, gums, and toothpicks are gaining popularity, especially among adolescents and young adults, with increased marketing.

6. England pubmed.ncbi.nlm.nih.gov

Lucy-Novel Flavored Nicotine Gum, Lozenges, and Pouches: Are They Misleading Consumers? [2023] Background: The packaging and marketing of nicotine gums, lozenges, and pouches can influence users' perceptions about which products are evidence-based for tobacco cessation and which are designed for nicotine maintenance-which could keep people nicotine dependent. Lucy, a company that produces flavored nicotine gums, lozenges, and pouches, could cause confusion by mimicking the packaging of traditional chewing gum and using similar marketing for its approved smoking cessation products and non-approved products. Methods: This commentary describes Lucy's marketing practices that could prolong nicotine dependence rather than aid cessation. Results: Lucy's marketing as "FDA approved for smoking cessation" (true for the lozenges but not the gum or pouches) and "PMTA [Premarket Tobacco Product Application] accepted" could create a false narrative of regulatory acceptance. Its scientific conference presentations could imply that it is endorsed by the scientific community. Its colorful pack design, emphasizing flavors and minimizing nicotine warnings, may attract youth and non-nicotine-users to initiate nicotine use. Conclusion: Lucy's promotion of its products as safe alternatives to other forms of tobacco, its packaging that recalls innocuous chewing gum, and its use of social media to advertise its products should be explored by researchers and considered by policymakers for potential population-level health effects.

7. England 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. [2021] The single-dose pharmacokinetics (PK) of a novel, non-tobacco-based nicotine pouch, ZYN, 3 and 6 mg, were compared with 8 mg General snus (part 1) and ZYN 8 mg was compared with 18 mg Longhorn moist snuff (part 2). The present study demonstrates the characteristics of three strengths of a novel tobacco-free oral snus, ZYN, viz. the extraction of nicotine from the oral cavity and its uptake into the systemic blood circulation. Comparison is made to Swedish General snus and American Longhorn moist snuff and from literature 4 mg Nicorette gum and mean of 13 brands of e-cigarettes.

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

Perceptions of oral nicotine pouches & their marketing among Ohio Appalachia smokers and smokeless tobacco users. [2023] Oral nicotine pouches (ONPs) are novel products, gaining popularity and marketed as "tobacco-free" alternatives to cigarettes and smokeless tobacco (SLT), but their public health impact is unknown. This study qualitatively examined ONP appeal and perceptions among cigarette smokers and SLT users from Ohio Appalachia.

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

The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool? [2023] Nicotine pouches to be put under the upper lip are a new category of products that are being rapidly developed and marketed as consumer goods with little research or regulatory oversight. We have identified research gaps in assessing their harm and benefit potential, and possible regulatory science approaches to inform the policies that can allow a maximization of the category's public health potential while minimizing unintended consequences. Implications: This commentary presents a potential blueprint for a comprehensive assessment of the nicotine pouches category. Data from the proposed research areas can better inform the regulatory policy decisions around the category, with the aim to maximize the category's tobacco harm reduction potential while minimizing unintended harms.