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}

Research Team

Amanda Palmer

Principal Investigator

Medical University of South Carolina

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)

Who Is Running the Clinical Trial?

Medical University of South Carolina

Lead Sponsor

Trials

994

Recruited

7,408,000+

Dr. Erik Summers

Medical University of South Carolina

Chief Medical Officer

MD from University of Alabama at Birmingham

Dr. Patrick J. Cawley

Medical University of South Carolina

Chief Executive Officer

MD, MBA

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

Findings from Research

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]

In a study of 30 adult smokers, the 4-mg nicotine pouch significantly reduced withdrawal cravings by 23 points within the first hour, outperforming nicotine gum and placebo, which showed reductions of 15 and 8 points, respectively.

Participants rated the nicotine pouch as more helpful and pleasant to use compared to gum, indicating a preference that could enhance its effectiveness as a smoking cessation aid.

NCBI (Pubmed)

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. Thornley, S., McRobbie, H., Lin, RB., et al.[2015]

A survey of 6,131 U.S. participants aged 13-40 revealed that 33% had ever used oral nicotine products, with higher usage rates among those aged 21-40 compared to those under 21.

Marketing significantly influences the likelihood of purchasing oral nicotine products, especially among younger users, who are more likely to buy products like Zyn pouches when they perceive marketing messages about appealing flavors and social comfort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use, marketing, and appeal of oral nicotine products among adolescents, young adults, and adults. Gaiha, SM., Lin, C., Lempert, LK., et al.[2023]

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]

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]

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

Nicotine delivery systems. [2015]

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]

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

Use, marketing, and appeal of oral nicotine products among adolescents, young adults, and adults. [2023]

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

Lucy-Novel Flavored Nicotine Gum, Lozenges, and Pouches: Are They Misleading Consumers? [2023]

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]

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

Perceptions of oral nicotine pouches & their marketing among Ohio Appalachia smokers and smokeless tobacco users. [2023]

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

The New Nicotine Pouch Category: A Tobacco Harm Reduction Tool? [2023]