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Nicotine pouches under the microscope: do they hook new users?

NCT ID NCT07128329

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study at Johns Hopkins University is testing nicotine pouches (like Zyn) in 120 adults—60 regular smokers and 60 people who rarely use nicotine. Participants will use the pouches in two lab sessions while researchers measure how much nicotine gets into the blood, how appealing the product feels, and any withdrawal symptoms. The goal is to help the FDA understand the potential impact of these products on both users and non-users.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Nicotine pouches (Zyn)
What this could lead to
If successful, this study could help regulators understand the potential risks and appeal of nicotine pouches, informing public health decisions.
What could go wrong
This is an early Phase 1 lab study with only 120 participants, so results may not reflect real-world use or long-term effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria (all participants): * greater than or equal to 21 years old * good general health based on screening procedures * vital signs in normal range (resting heart rate less than 110bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 100mmHg) * negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session * no self-reported prior use of oral nicotine pouches * Not actively trying to quit smoking or using smoking cessation medication (e.g., nicotine replacement therapy) Additional inclusion criteria (smokers): * self-report currently smoking cigarettes daily * exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening * meet criteria for tobacco use disorder * no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days Additional inclusion criteria (non-nicotine users): * self-report previously using nicotine/tobacco but no more than 100 lifetime uses across all routes of administration * no self-reported nicotine/tobacco uses in the past 30 days * urine cotinine less than 100 ng/ml at screening. Exclusion criteria (all participants): * psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month * current use of OTC drugs, supplements/vitamins, or prescription medications that, in the opinion of medical staff, will impact safety * currently have severe dependence for cannabis * history of or current significant medical condition that, in the opinion of medical staff, will impact safety * current psychiatric condition or substance use disorder (aside from tobacco use disorder for smokers), that, in the opinion of medical staff, will impact safety * women who are pregnant, planning to become pregnant, or are breast-feeding

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)

    RECRUITING

    Baltimore, Maryland, 21224, United States

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