Nicotine Pouches for Nicotine Study

Overseen By Lakshmi Kumar, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: OTC drugs, Supplements, Prescription meds

Disqualifiers: Psychoactive drugs, Severe cannabis dependence, others

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

Compensation: Varies

Number of Visits: 3

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how nicotine pouches affect daily cigarette smokers and infrequent nicotine users. Participants will use various labeled nicotine pouches in a controlled setting to observe their effects. The study aims to understand the impact on both frequent and infrequent nicotine users. Ideal participants are daily cigarette smokers or those who have used nicotine fewer than 100 times in their lives and have not used it in the last 30 days. This research will help assess how nicotine pouches might be regulated for public health. As a Phase 1 trial, this study focuses on understanding how nicotine pouches work in people, offering participants the unique opportunity to be among the first to experience this treatment.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but you cannot participate if you are using over-the-counter drugs, supplements, or prescription medications that could impact safety according to medical staff.

Is there any evidence suggesting that nicotine pouches are likely to be safe for humans?

Research shows that nicotine pouches carry risks. Studies indicate that swallowing these pouches can be harmful, and skin contact may be toxic. They contain nicotine, which is addictive and can harm health, particularly for certain groups. Pregnant women, young adults, and those who do not already use nicotine products should avoid them. Although some might consider them safer than smoking, they still pose health risks. Handle these products carefully and keep them away from children. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about nicotine pouches because they provide a smokeless and potentially less harmful way to consume nicotine compared to traditional cigarettes and vaping. Unlike smoking, which involves combustion and releases harmful toxins, these pouches deliver nicotine orally, eliminating exposure to smoke and its associated risks. Additionally, the convenience and discreetness of nicotine pouches, which can be used without needing to step outside or produce vapor, make them an attractive alternative for those seeking to quit smoking or reduce nicotine intake.

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

Research has shown that nicotine pouches might assist those looking to switch from smoking cigarettes. These pouches are less harmful than cigarettes but still deliver similar nicotine levels, offering a potential alternative for smokers. In this trial, participants will receive nicotine pouches labeled as either version 1 or version 2. One study suggested that pouches with higher nicotine content could be particularly beneficial for adults attempting to quit smoking. The increasing use of nicotine pouches indicates they may be becoming a more accepted alternative to smoking. Overall, nicotine pouches could help reduce the health risks associated with smoking. ^{4 6 7 8 9}

Who Is on the Research Team?

Tory Spindle, PhD

Principal Investigator

Johns Hopkins University School of Medicine, Department of Psychiatry and Behavioral Sciences

Are You a Good Fit for This Trial?

This trial is for adult cigarette smokers and infrequent nicotine users who are in good health, not trying to quit smoking, and have no history of regular use of other tobacco products. Smokers must meet specific breath CO and urine cotinine levels. Non-users should have low cotinine levels and limited lifetime nicotine use.

Inclusion Criteria

Smokers must have exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening

I currently smoke cigarettes every day.

Participants must be in good general health based on screening procedures

Exclusion Criteria

Participants must not have psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in the past month

Participants must not currently have severe dependence for cannabis

Participants must not have a history of or current significant medical condition that, in the opinion of medical staff, will impact safety

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Experimental Sessions

Participants complete two counterbalanced lab sessions using nicotine pouches under controlled conditions

1 week

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after experimental sessions

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nicotine Pouches

Trial Overview The study tests the acute effects of oral nicotine pouches on both frequent cigarette smokers (60 participants) and infrequent nicotine users (60 participants). Each participant will attend two lab sessions where they'll use these pouches under controlled conditions.

How Is the Trial Designed?

Group I: Pouch label version 2 Experimental Treatment 1 Intervention

Nicotine pouches with label 2

Group II: Pouch label version 1 Active Control 1 Intervention

Nicotine pouches with label 1

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

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 ... Findings suggest pouches show promise for helping adults transition from smoking, with higher nicotine pouches potentially more effective and ...

2. academic.oup.com academic.oup.com/ntr/article/27/4/598/7693924

Potential Impact of Oral Nicotine Pouches on Public Health ONPs appear to be less toxic than cigarettes and deliver comparable nicotine, presenting an alternative for combustible product users.

3. 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.

4. keck.usc.edu keck.usc.edu/news/use-of-nicotine-pouches-increases-significantly-among-u-s-teens/

Use of nicotine pouches increases significantly among U.S. ... Like the USC-led survey, the NYTS also found significant increases in lifetime use of nicotine pouches between 2023 and 2024 among U.S. high ...

5. yalemedicine.org yalemedicine.org/news/nicotine-pouches

What Parents Should Know About Nicotine Pouches A 2023 study from the Centers for Disease Control and Prevention (CDC) said that about 1.5% of middle and high school students reported using ...

6. ctrp.uky.edu ctrp.uky.edu/assets/pdf/webdocs/NP2%20High%20Moisture%20Nicotine%20Pouches%20Safety%20Data%20Sheet.pdf

High Moisture Nicotine Pouches NP2 10.9mg Slim The product is harmful if swallowed, contains nicotine, and is for research, analysis, and scientific education. Keep out of reach of children. ...

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

Nicotine Pouches | Smoking and Tobacco Use There are no safe tobacco products, including nicotine pouches. · Youth, young adults, and women who are pregnant should not use nicotine pouches ...

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

What to know about nicotine pouches What this approval doesn't mean, however, is that nicotine pouches are safe for everyone. For young people or people who don't already use ...

9. cdn.caymanchem.com cdn.caymanchem.com/cdn/msds/16535m.pdf

Safety Data Sheet Acute Toxicity - Oral 3. H301 Toxic if swallowed. Acute Toxicity - Dermal 2 H310 Fatal in contact with skin. d. ~GHS09 Environment.