Nicotine Pouches for Nicotine Addiction

Overseen By William A Middleton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: William Middleton

Disqualifiers: Non nicotine pouch user, <18 years old

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how effectively nicotine pouches can replace cigarettes as a low-harm alternative, focusing on different dosages and prices. Researchers want to determine if these pouches can help reduce smoking by offering a more appealing substitute. Eligible participants must be current tobacco users with experience using nicotine pouches and users of the Prolific crowdsourcing platform. As an unphased trial, this study provides an opportunity to contribute to innovative research on smoking alternatives.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to consult with the trial coordinators for more details.

What prior data suggests that nicotine pouches are safe for nicotine addiction treatment?

The FDA has not approved nicotine pouches for quitting smoking, indicating a need for more research to understand their effects and safety. Some individuals have successfully used these pouches to quit smoking, with 41% reporting success in one study. However, nicotine pouches are approved only for sale, not as a smoking cessation treatment.

Research continues to explore the risks and health impacts of nicotine pouches. One study examined 31 samples of these pouches to assess potential health risks. While they might assist some people in quitting smoking, their safety remains uncertain. The long-term effects are still unclear, as more scientific evidence is needed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Nicotine pouches are unique because they offer a smokeless and potentially less harmful alternative to traditional nicotine replacement therapies like patches, gums, and lozenges. Unlike these options, nicotine pouches are discreet and don't require chewing or sticking to the skin. Researchers are excited because these pouches could make quitting smoking more appealing and accessible, especially for those who want to avoid the social stigma of visible or cumbersome alternatives. Additionally, by experimenting with dosage and pricing conditions, there's potential to fine-tune how effective these pouches can be in helping people reduce or quit nicotine use entirely.

What evidence suggests that nicotine pouches might be an effective treatment for nicotine addiction?

Research has shown that nicotine pouches might help people smoke fewer cigarettes. In one study, about 41% of users reported quitting smoking completely, while 38% managed to cut down. Another study found that nicotine pouches helped people smoke less over four weeks. However, it remains unclear if they reduce the overall harm from smoking. While these results are promising, more research is needed to confirm their effectiveness in helping people quit smoking entirely. Participants in this trial will receive randomized dosages of nicotine pouches to further investigate their effectiveness. ^{2 3 6 7 8}

Who Is on the Research Team?

Mikhail Koffarnus, PhD

Principal Investigator

University of Kentucky

Are You a Good Fit for This Trial?

This trial is for individuals who use tobacco products like chewing tobacco, vape, or are dealing with nicotine addiction. To participate, they must be willing to try nicotine pouches as a substitute for cigarettes and engage in an online study using crowdsourcing software.

Inclusion Criteria

Tobacco users will be eligible for a general screener

Nicotine pouch users will be eligible for the full marketplace study

I use the website Prolific.

Exclusion Criteria

Non-nicotine pouch user

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online screening

Experimental Tobacco Marketplace

Participants engage in a virtual marketplace to assess demand and substitution for nicotine pouches at varying dosages and prices

1 hour

Online participation

Follow-up

Participants are monitored for data analysis on demand and substitution patterns

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Pouch Dosage

Trial Overview The study aims to test the effectiveness of different dosages and price points of nicotine pouches as substitutes for cigarettes. Participants will interact with an electronic tobacco marketplace to assess their preferences and behaviors regarding these novel products.

How Is the Trial Designed?

Group I: Nicotine pouch purchase Experimental Treatment 1 Intervention

All participants will be experimentally manipulated by randomizing the dosage of nicotine pouches across varying pricing conditions.

Who Is Running the Clinical Trial?

William Middleton

Lead Sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12377922/

The Effects of Oral Nicotine Pouches on Cigarette Smoking ... Though oral nicotine pouches significantly reduced cigarette smoking over 4 weeks, they did not decrease tobacco-related harm exposure, likely ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.70193?af=R

Nicotine pouches and clinical outcomes related to smoking ... While pilot trial data suggest that NPs can help reduce cigarette consumption and dependence over several weeks, full switching from cigarettes ...

3. nature.com nature.com/articles/s41598-025-15070-0

Prevalence, safety, and role of nicotine pouches in ... Among those who had used nicotine pouches, 41.0% reported success in quitting smoking, while 38.1% experienced partial success, and 20.9% were ...

4. cochranelibrary.com cochranelibrary.com/cdsr/doi/10.1002/14651858.CD016220.pub2/

Oral nicotine pouches for cessation or reduction of use ... Based on two small studies, it was not clear whether using nicotine pouches helped more people to quit smoking compared to instructions to ...

5. health.unl.edu health.unl.edu/nicotine-pouches-are-they-safer-chewing-smoking-or-vaping/

Are nicotine pouches safer than chewing, smoking or vaping? Are nicotine pouches a safe approach to quitting nicotine dependence? There is no data to show nicotine pouches as a safe or effective way to quit.

6. cdc.gov cdc.gov/tobacco/nicotine-pouches/index.html

Nicotine Pouches | Smoking and Tobacco Use The FDA has not approved any nicotine pouches to help people quit smoking. Researchers need more information to understand the potential effects ...

7. mdanderson.org mdanderson.org/cancerwise/what-to-know-about-nicotine-pouches.h00-159773289.html

What to know about nicotine pouches Another important note is that right now, these nicotine pouches are only approved by the FDA for marketing – not tobacco cessation.

8. sciencedirect.com sciencedirect.com/science/article/pii/S2214750024001628

Beyond smoking: Risk assessment of nicotine in pouches This study aims to assess nicotine in pouches and potential risks for health damage. 31 samples of nicotine pouches were collected and analyzed.