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Nicotine pouches put to the test: can they match the cigarette experience?

NCT ID NCT07829939

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Last updated Sep 21, 2026

Summary

Researchers at the University of California, San Francisco are studying how oral nicotine pouches affect healthy adults who already smoke or vape. The trial compares three pouch strengths (0 mg, 3 mg, and 6 mg) with each participant's usual cigarette or e-cigarette over four eight-hour hospital visits. The team measures nicotine levels in the blood, ratings of satisfaction and withdrawal relief, and changes in heart rate and blood pressure. The goal is to understand whether pouches deliver nicotine in a way that could substitute for inhaled products and what cardiovascular effects they have.

What this could mean

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

Active substance
oral nicotine pouches at 0 mg, 3 mg, and 6 mg strengths
What this could lead to
If the pouches deliver nicotine in a way that satisfies users and relieves withdrawal, they could offer a less harmful alternative to smoking or vaping. The heart-rate and blood-pressure data could also help regulators understand the cardiovascular profile of these products.
What could go wrong
This is a small, short-term Phase 1 study in healthy volunteers, so it cannot show whether pouches reduce disease or help people quit. Participants use the products for only four days, and the results may not reflect long-term use or real-world behavior.

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 24 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

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 to 65 years

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: * Healthy based on medical history and limited physical examination. * Heart rate \< 105 BPM\* * Systolic Blood Pressure \< 160 and \> 90\* * Diastolic Blood Pressure \< 100 and \> 50\* \*Considered out of range if both machine and manual readings are above/below these thresholds. * Body Mass Index ≤ 38.0 * Willingness to abstain from illicit drug use for the duration of the study and cannabis for 48 hours prior to each hospital visit * Group 1 (n=12) Smoke cigarettes regularly (smoked 20 of past 30 days, 5 or more cigarettes per day) * Group 2 (n=12) use nicotine-containing e-cigarettes regularly (use on 20 of past 30 days) * Participants may be dual users of cigarettes and e-cigarettes, but during the study will use their predominant product (i.e., the product they use on more days in the past 30 and more frequently on days that they use it). * Saliva Cotinine \>50 ng/ml * Age: ≥ 21 years old and ≤ 65 years old * Willingness to abstain from smoking all combustible products (tobacco and cannabis) for 12 hours before admission * Willingness to abstain from nicotine products (vaping/oral use) 12 hours before each admission Exclusion Criteria: * • Unstable medical conditions: * Heart disease * Seizures * Cancer * Thyroid disease (okay if controlled with medication) * Diabetes * Hepatitis B or C or Liver disease * Glaucoma * Kidney disease or urinary retention * An ulcer in the past year * Diagnosis of asthma or COPD • Drug/Alcohol Dependence * Alcohol or illicit drug dependence within the past 12 months (currently in treatment) with the exception of those who recently completed an alcohol/drug treatment program * Positive toxicology test at the screening visit (THC \& prescribed medications okay) * Opioid replacement therapy (including methadone, buprenorphine, or other) • Psychiatric conditions * Current or past schizophrenia, and/or current or past bipolar disorder * Major depression, current or within the past year * Major personality disorder * Participants with current or past minor or moderate depression and/or anxiety disorders will be reviewed by the PI \[study physician\] and considered for inclusion * History of psychiatric hospitalizations are not exclusionary, but study participation will be determined as per PI's \[study physician's\] approval * Suicidal ideation within the past month * Current regular use of any psychiatric medications with the exception of SSRIs and SNRIs and current evaluation by the PI that the participant is otherwise healthy, stable, and able to participate * Congenital or acquired immunodeficiency disorders (i.e. HIV, congenital immune deficiency syndrome, chronic diseases) * Other disorders (i.e. ICU, malnutrition, immunosuppressive therapy) * Traumatic brain injury * Recent onset or change (worsening) in cough, fever and/or abdominal symptoms (vomiting or pain) in the past two weeks * Medications * Concurrent use of nicotine-containing medications * Any stimulant medications (ex. Adderall) generally given for ADHD treatment * Hypertension medications • Other/Misc. Chronic Health Problems * Oral thrush * Fainting * Other "life threatening illnesses" as per study physician's discretion • Pregnancy * Pregnancy (self-reported and urine pregnancy test) * Breastfeeding (determined by self-report) * Concurrent participation in another clinical trial * Inability to communicate in English * Current regular user of ONPs * Planning to quit smoking or vaping within the next 60 days * Uncomfortable with getting blood drawn

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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

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Contacts and locations

Locations

  • Zuckerberg San Francisco General Hospital

    San Francisco, California, 94143, United States

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