Healthy Adult ParticipantsPhase 1NCT07829939
Understanding Oral Nicotine Pouch Use in Healthy Volunteers
A Phase 1 study testing 0 mg oral nicotine pouches, 3 mg oral nicotine pouches and 6 mg oral nicotine pouches in people with Healthy Adult Participants, run by University of California, San Francisco at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are: 1. With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Participants
- What is being tested?
- 0 mg oral nicotine pouches, 3 mg oral nicotine pouches and 6 mg oral nicotine pouches
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Oct 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- • Unstable medical conditions:
- Heart disease
- Seizures
- Cancer
- Thyroid disease (okay if controlled with medication)
- Diabetes
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Zuckerberg San Francisco General Hospital
San Francisco, California, 94143
Lisa Lawrence, BA, 415-502-2465, lisa.lawrence@ucsf.edu
Armando Barraza, BA, 4155022465, armando.barraza@ucsf.edu
About this study
Official title: Clinical Pharmacology of Oral Nicotine Pouches
The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are:
- With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
- With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping. Participants will rate ONP use as a satisfactory substitute for cigarette smoking or vaping.
- Examine the cardiovascular effects (blood pressure and heart rate) of placebo, 3mg and 6mg ONPs, and the participants' usual cigarette or e-cigarette (vape).
Read more
Participants will:
- use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape)
- visit the hospital research ward on 4 separate days for 8 hours each day
- use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days
- Conditions
- Healthy Adult Participants
- Being tested
- 0 mg oral nicotine pouches, 3 mg oral nicotine pouches, 6 mg oral nicotine pouches, cigarette or e-cigarette
- Keywords
- oral nicotine pouches, nicotine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0 mg oral nicotine pouchesDrug
placebo
3 mg oral nicotine pouchesDrug
low strength oral nicotine pouches
6 mg oral nicotine pouchesDrug
high strength oral nicotine pouches
cigarette or e-cigaretteDrug
Participants will use their own cigarette or e-cigarette (vape)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | placebo (0 mg nicotine pouches) used on one study day (8 hours) Receives: Drug: 0 mg oral nicotine pouches |
| 3 mg ONP | Experimental | 3 mg oral nicotine pouches used on one study day (8 hours) Receives: Drug: 3 mg oral nicotine pouches |
| 6 mg ONP | Experimental | 6 mg oral nicotine pouches used on one study day (8 hours) Receives: Drug: 6 mg oral nicotine pouches |
| Inhaled nicotine | Experimental | Participants will use their own brand of either cigarettes or e-cigarettes (vapes) on one study day (8 hours) Receives: Drug: cigarette or e-cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
This will be assessed by comparing ratios of nicotine area under the plasma nicotine concentration time curve.
Measured: 7 hours post-dose
Secondary outcomes (2)
With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping.
This will be assessed by administering the Modified Cigarette Evaluation Questionnaire (mCEQ) throughout the day. The mCEQ uses three multi-item subscales and two single items: "Smoking Satisfaction" (items 1, 2, and 12); "Psychological Reward" (items 4 through 8); "Aversion" (items 9 and 10); "Enjoyment of Sensations" (item 3); and "Craving Reduction" (item 11). The items are rated on a seven-point scale ranging from 1 (not at all) to 7 (extremely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. The minimum total score = 7 and maximum = 35 with higher scores indicating greater intensity on that scale.
Measured: Pre-dose until 7 hours post-dose.
Cardiovascular effects among arms using heart rate as a measure
The investigators will compare maximum change in heart rate as well as an integrated measure of heart rate after the first dose of nicotine over the following 7 hours among dosages.
Measured: Pre-dose until 7 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult ParticipantsStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Neal Benowitz, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07829939
- Sponsor's protocol ID
- STUDY00000041
- Other IDs
- R01DA065785
- Status last verified
- Sep 2026
- First submitted
- 1 Sep 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: No identifiable participant information (PHI) will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Pharmacology of Oral Nicotine Pouches
- ClinicalTrials.gov ID
- NCT07829939
- Acronym / sponsor ID
- STUDY00000041
- Conditions
- Healthy Adult Participants
- Keywords
- oral nicotine pouches, nicotine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 21 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to understand how using oral nicotine pouches effects the body in healthy volunteers. The main questions it aims to answer are:
- With multiple use of oral nicotine pouches (ONPs) throughout the day, participants will adjust their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
- With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping. Participants will rate ONP use as a satisfactory substitute for cigarette smoking or vaping.
- Examine the cardiovascular effects (blood pressure and heart rate) of placebo, 3mg and 6mg ONPs, and the participants' usual cigarette or e-cigarette (vape).
Participants will:
- use 3 different strengths of ONPs (0 mg, 3 mg, 6 mg) and their usual inhaled nicotine product (cigarette or e-cigarette/vape)
- visit the hospital research ward on 4 separate days for 8 hours each day
- use one of each of the products in a randomized order (by chance, like flipping a coin) on each of the 4 hospital study days
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: 0 mg oral nicotine pouchesplacebo (0 mg nicotine pouches) used on one study day (8 hours) |
| 3 mg ONP | Experimental | Drug: 3 mg oral nicotine pouches3 mg oral nicotine pouches used on one study day (8 hours) |
| 6 mg ONP | Experimental | Drug: 6 mg oral nicotine pouches6 mg oral nicotine pouches used on one study day (8 hours) |
| Inhaled nicotine | Experimental | Drug: cigarette or e-cigaretteParticipants will use their own brand of either cigarettes or e-cigarettes (vapes) on one study day (8 hours) |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy based on medical history and limited physical examination.
- Considered out of range if both machine and manual readings are above/below these thresholds.
Key exclusion criteria (43 listed)
- • Unstable medical conditions:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0 mg oral nicotine pouchesplacebo | Drug | Placebo |
| 3 mg oral nicotine poucheslow strength oral nicotine pouches | Drug | 3 mg ONP |
| 6 mg oral nicotine poucheshigh strength oral nicotine pouches | Drug | 6 mg ONP |
| cigarette or e-cigaretteParticipants will use their own cigarette or e-cigarette (vape) | Drug | Inhaled nicotine |
Primary outcome
With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping.
Time frame: 7 hours post-dose
This will be assessed by comparing ratios of nicotine area under the plasma nicotine concentration time curve.
2 secondary outcomes
With multiple use of ONPs throughout the day, participants will experience satisfaction, psychological reward and relief of withdrawal symptoms similar to that seen with cigarette smoking or vaping.
Time frame: Pre-dose until 7 hours post-dose.
Cardiovascular effects among arms using heart rate as a measure
Time frame: Pre-dose until 7 hours post-dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. No identifiable participant information (PHI) will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Neal Benowitz, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 0 mg oral nicotine pouches, 3 mg oral nicotine pouches and 6 mg oral nicotine pouches in people with Healthy Adult Participants, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 43 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Lawrence, BA (4155022465, lisa.lawrence@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
With multiple use of ONPs throughout the day, participants will titrate their intake of nicotine to be similar to or higher than that seen with cigarette smoking or vaping. (time frame: 7 hours post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.