Nicotine pouches put to the test: can they match the cigarette experience?
NCT ID NCT07829939
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 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: * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy adult participants are added.
By submitting, you agree to our Terms of use
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
-
Zuckerberg San Francisco General Hospital
San Francisco, California, 94143, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a neck device dial down pain by zapping the vagus nerve?
- Tight calves may dull the Sole's sense of touch
- Can a migraine pill sway the Body's balance reflex?
- Can an experimental drug share the Body's chemical highways without causing a pileup?
- Can dirty city air speed up the Body's aging clock?
- Can a nasal spray change how fair we are?