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Nicotine pouches put to the test: can they replace cigarettes?

NCT ID NCT05335915

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 24, 2026 · Updated 2 times

Summary

This study tested how tobacco-free nicotine pouches affect the body and mind compared to regular cigarettes. Seventy-one adult smokers tried different doses and flavors of pouches, as well as their own cigarettes, in a controlled setting. Researchers measured nicotine levels in the blood and asked participants about cravings and satisfaction. The goal is to see if these pouches could be a less harmful option for people who smoke.

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 (tobacco-free) and cigarettes
What this could lead to
If successful, this could help understand whether nicotine pouches are a less harmful alternative to smoking for adults who already smoke.
What could go wrong
This is a small, early-phase study in healthy smokers, so results may not apply to everyone. It measures short-term effects only, not long-term health outcomes or addiction risk.

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

71 people

The number who actually took part.

Started

Jul 2022

Finished

Aug 2025

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: 1. ≥ 21 years old 2. good general health based on screening procedures (e.g., physical exam, blood testing) 3. vital signs in normal range (resting heart rate less than 100bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 90mmHg) 4. negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session 5. self-report currently smoking daily 6. self-report at least a one year history of regular smoking 7. exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening 8. meet criteria for at least mild tobacco use disorder 9. no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days 10. no self-reported prior use of novel oral nicotine pouches 11. exhaled breath CO less than 10 ppm upon arrival for each study session. Exclusion Criteria: 1. Psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month 2. Current use of over-the-counter (OTC) drugs, supplements/vitamins, or prescription medications that, in the opinion of the investigators or medical staff, will impact safety 3. Use of cannabis \>4 times per week 4. History of or current significant medical condition that, in the opinion of the investigators or medical staff, will impact safety 5. Current psychiatric condition or substance use disorder (aside from tobacco use disorder) that, in the opinion of the investigators or medical staff, will impact safety or study outcomes 6. Women who are pregnant, planning to become pregnant, or are breast-feeding 7. Currently seeking treatment to quit smoking or currently using a nicotine/tobacco cessation product. 8. Enrollment in another clinical trial in the past 30 days

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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.

Contacts and locations

Locations

  • Johns Hopkins Behavioral Pharmacology Research Unit

    Baltimore, Maryland, 21224, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.