Nicotine pouches put to the test: can they replace cigarettes?
NCT ID NCT05335915
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
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Jul 2022
- Finished
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Aug 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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
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