Nicotine Pouches for Nicotine Addiction

Overseen By Dae Hee Han, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

Disqualifiers: Pregnancy, Stroke, Seizures, Heart disease, others

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

Compensation: Varies

Number of Visits: 4

Duration: 2-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to study how different nicotine concentrations and pH levels in nicotine pouches affect taste, appeal, and potential for addiction. Participants will test pouches with varying nicotine levels and acidity to determine how these factors influence their experience and the likelihood of misuse. Ideal candidates for this trial are current users of nicotine pouches, e-cigarettes, and tobacco who do not plan to quit nicotine soon. As an unphased trial, this study offers participants the chance to contribute to understanding the factors influencing nicotine pouch use and addiction.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It mainly focuses on nicotine use, so it's best to discuss your medications with the trial team.

What prior data suggests that nicotine pouches are safe for use?

Research shows that nicotine pouches are still under study to determine their safety. So far, the FDA has not approved them for smoking cessation, indicating a need for more information about their effects.

In some studies, people have successfully quit smoking using nicotine pouches. However, these pouches contain nicotine, which is addictive, and may also have other harmful chemicals. One study examined 31 samples of nicotine pouches to assess potential health risks.

While research on nicotine pouches continues, it's important to consider these factors. Their safety and effectiveness are not yet fully understood. Those considering joining a trial should remember that more research is needed to understand all the possible risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about nicotine pouches as a treatment for nicotine addiction because they offer a novel approach with potentially customizable options. Unlike traditional methods such as nicotine replacement therapies (like patches or gum) that offer fixed doses, these pouches vary in nicotine concentration and pH levels, allowing for a more personalized experience. This flexibility means that users might better control their nicotine intake, potentially improving the effectiveness of quitting smoking. Additionally, the discreet and easy-to-use nature of nicotine pouches could make them more appealing to users who prefer a less visible method of managing their cravings.

What evidence suggests that nicotine pouches are effective for nicotine addiction?

Research has shown that nicotine pouches can help people smoke fewer cigarettes. In one study, 41% of users quit smoking, and 38.1% reduced their smoking. Another study found that these pouches significantly decreased the number of cigarettes people smoked. The pouches deliver a similar amount of nicotine as cigarettes, which helps reduce cravings. Overall, nicotine pouches seem promising for those wanting to cut down or quit smoking, but they may not reduce the harm from tobacco. Participants in this trial will self-administer nicotine pouches with varying nicotine concentrations and pH levels, allowing researchers to evaluate their effectiveness in reducing smoking. ^{1 3 6 7 8}

Who Is on the Research Team?

Dae Han, PhD

Principal Investigator

Rollins School of Public Health

Are You a Good Fit for This Trial?

This trial is for young adult nicotine pouch users who want to help study the effects of different nicotine concentrations and pH levels in these products. Participants should be current NP users without any health conditions that could affect their sensory experience or product appeal assessment.

Inclusion Criteria

Current established users of nicotine pouches (have used nicotine pouches in the past 30 days & currently use nicotine pouches every day or someday)

Positive cotinine test via saliva test strip

Those who are unmotivated to quit nicotine use

Exclusion Criteria

Planning to cut down or quit using nicotine in the next 30 days

Currently pregnant or breastfeeding

I have a history of seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants self-administer nicotine pouches with varying nicotine concentrations and pH levels across four visits

2-4 weeks

4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Pouch

Trial Overview The study is testing how low and high doses of nicotine in pouches, combined with low and high pH levels, impact the user's sensory experience, how much they like the product, and its potential for abuse among young adults.

How Is the Trial Designed?

Group I: Nicotine Pouches group Experimental Treatment 4 Interventions

Participants will self-administer NPs that differ along two experimental factors: nicotine concentration (low \[e.g., 3-4 mg\] vs. high \[e.g., 6-8 mg\]) and pH level (low \[\<8.5\] vs. high \[≥8.5\]). Each participant will be exposed to all four NP conditions in randomized order, with one condition administered per visit.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

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 ... First, while a 2-week crossover study showed that NPs reduced the number of cigarettes smoked, this reduction was similar to that achieved with ...

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. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41001885/

Nicotine pouches and clinical outcomes related to smoking ... Tobacco-free nicotine pouches appear to be well tolerated and may reduce cigarette consumption compared with control, with effects similar ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2772724625000721

Nicotine Pouch Pharmacokinetics Compared to Smoked ... A meta-analysis of three trials showed that 4 mg pouches delivered 91.73% (95% CI 85.03%–98.42%) of cigarette total nicotine exposure. Peak ...

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. 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.

8. cancer.org cancer.org/cancer/latest-news/what-to-know-about-nicotine-pouches-and-cancer-risk.html

What to Know About Nicotine Pouches and Cancer Risk Nicotine pouches contain nicotine, which is highly addictive, and may include other harmful chemicals. Learn about the health risks of ...