Nicotine AddictionNCT07165808
Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches
A study testing Nicotine pouch: Low dose, Nicotine pouch: High dose and Low pH in people with Nicotine Addiction, run by Emory University at 1 site in United States.
Trial summary
The goal of this study is to assess the effects of nicotine concentration and its interplay with pH on sensory experience, product appeal, and abuse liability of NPs among young adults NP users. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Addiction
- What is being tested?
- Nicotine pouch: Low dose, Nicotine pouch: High dose and Low pH
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Feb 2026to Jan 2028
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Current established users of nicotine pouches (have used nicotine pouches in the past 30 days \& currently use nicotine pouches every day or someday)
- Positive cotinine test via saliva test strip
- Those who are unmotivated to quit nicotine use
- Read and speak English.
- Poly-users of nicotine pouches, e-cigarettes (e.g., vape ≥20 days/month), and tobacco (e.g., ≥4 cigarettes/day for ≥2 years) will be eligible for participation
Who cannot join
- Planning to cut down or quit using nicotine in the next 30 days
- Currently pregnant or breastfeeding
- History of stroke, seizures, high blood pressure, heart disease/problems, or cardiovascular disease contraindications for nicotine.
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, 1 recruiting
- Recruiting
Rollins School of Public Health
Atlanta, Georgia, 30322
About this study
The goal of this study is to assess the effects of nicotine concentration and its interplay with pH on sensory experience, product appeal, and abuse liability of NPs among young adults NP users.
Primary objective is to assess the effect of variation in nicotine concentration in nicotine pouches (NPs) and its interaction effect with pH level on three proximal outcomes of relevance to regulation: (1) sensory experience, (2) product appeal, and (3) abuse liability of NPs.
Read the detailed description
Oral nicotine pouches (NPs) are a rapidly growing segment of nicotine products regulated by the U.S. Food and Drug Administration (FDA). These microfiber pouches contain nicotine but no tobacco leaf, and they dissolve in the mouth without requiring spitting. Between late 2019 and early 2022, NP sales surged from 126 million to 808 million units. Their sleek packaging, concealability, and "tobacco-free" claims have made them particularly appealing to young adults, with recent studies showing that over 10% of young adults reported using NPs in the past 30 days. However, this popularity raises health concerns. NPs deliver nicotine efficiently through buccal absorption, leading to rapid increases in blood nicotine levels, which may contribute to oral toxicity, cardiovascular effects, and nicotine dependence. These factors also elevate the abuse liability of NPs-defined as the likelihood of non-medical use leading to harmful consequences.
The FDA has the authority to impose stricter regulations on products with characteristics that enhance appeal and sensory experience, especially among youth. For instance, the agency has proposed banning menthol cigarettes due to their ability to mask irritation and encourage deeper inhalation of nicotine. Similar regulatory scrutiny is now being applied to emerging products like NPs. One key factor influencing product appeal is nicotine formulation. Free-base nicotine, commonly used in non-combustible products like e-cigarettes (ECs), has aversive effects such as bitterness and airway irritation, especially at high concentrations. To counter this, manufacturers began adding organic acids to convert nicotine into a protonated salt, lowering the product's pH and improving its palatability. This shift not only enhances the sensory experience but also increases the abuse liability of high-nicotine products. Evidence suggests that regulating acid additives or setting minimum pH levels could reduce the appeal of these products. Since NPs also use acid additives to lower pH, they share similar characteristics with ECs that attract young users, underscoring the need for targeted regulatory action.
- Conditions
- Nicotine Addiction
- Being tested
- Nicotine pouch: Low dose, Nicotine pouch: High dose, Low pH, High pH
- Keywords
- Nicotine Addiction, Oral Nicotine Pouches, Behavioral Responses
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine pouch: Low doseOther
Nicotine pouch: 3-4 mg
Nicotine pouch: High doseOther
Nicotine pouch: 6-8 mg
Low pHOther
Nicotine pouch with low pH level [<8.5]
High pHOther
Nicotine pouch with high pH level [>8.5]
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Pouches group | Experimental | Participants will self-administer NPs that differ along two experimental factors: nicotine concentration (low [e.g., 3-4 mg] vs. high [e.g., 6-8 mg]) and pH level (low [<8.5] vs. high [≥8.5]). Each participant will be exposed to all four NP conditions in randomized order, with one condition administered per visit. Receives: Other: Nicotine pouch: Low dose; Other: Nicotine pouch: High dose; Other: Low pH; Other: High pH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abuse liability: Amount of time with Nicotine product
Total amount of time with Nicotine Pouches in mouth (excluding periods in between NPs after disposal)
Measured: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Abuse liability: Number of Nicotine Pouches used
Total number of Nicotine Pouches used (i.e., larger number and longer time with Nicotine Pouches, higher abuse ability.
Measured: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Subjective effects measures: Drug Effects Questionnaire
During the session, participants will also repeatedly (every 30 min) complete the subjective effects measures of abuse liability of NP (using VAS), which will be developed based on the Drug Effects Questionnaire (DEQ). A modified version of the DEQ will be used to rate acute responses to the NP on the Visual Analogue Scale (range, 0-100).
Items assess liking/wanting (e.g., "I enjoy nicotine buzz," "I feel good effects from the NP," "I want more," "I feel the NP strength," and "I like the NP effect").
Measured: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Subjective effects measures: Modified Cigarette Evaluation Questionnaire
Modified Cigarette Evaluation Questionnaire will also be used to measure domains of subjective reinforcing effects (product satisfaction, psychological reward; e.g., "NP is satisfying" on a 7-point scale (0-7).
Measured: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Product appeal
After each administration, participants will use visual analogue scales (VAS, 0-100 range) to rate the product they just used: (1) "How much did you like the product?" (liking); (2) "How much did you dislike the product?" (disliking); and (3) "Would you use the product again?" (use again). A composite appeal score will also be calculated by averaging the 3 appeal ratings (Cronbach's α will be estimated to assess scale reliability; disliking will be reverse-scored).
Measured: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Sensory Attribute
Participants will answer following sensory quality questions: (1) "How sweet was the product?"; (2) smooth?; (3) bitter?; and (4) harsh? (VAS 0-100, "Not at all" to "Extremely". Burning and tingling sensation will be measured at each trial.
Measured: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Secondary outcomes (6)
Nicotine product use history: Number of days
Information will be collected on past 30-day number of days used nicotine pouches (NPs)
Measured: past 30-day
Nicotine product use history: Number of Nicotine product
Number of Nicotine product used per day
Measured: past 30-day
Nicotine product use history: Amount of time with Nicotine product
Amount of time with Nicotine product in mouth per episode
Measured: past 30-day
Nicotine Pouches brand
Data on brand names of NPs will be collected
Measured: past 30-day
Number of e- cigarettes
Number of e- cigarettes used in past 30 days.
Measured: past 30-day
Tobacco use
Number of tobacco products used in last 30 days
Measured: past 30-day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start13 Feb 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine AddictionStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will take the intervention along two experimental factors: nicotine concentration (low \[e.g., 3-4 mg\] vs. high \[e.g., 6-8 mg\]) and pH level (low \[\<8.5\] vs. high \[≥8.5\]). Each participant will be exposed to all four NP conditions in randomized order, with one condition administered per visit.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Dae Hee Han, Emory University
- Investigators
- Dae Han, PhD, Principal investigator, Rollins School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07165808
- Sponsor's protocol ID
- STUDY00009622
- Other IDs
- R00DA058241-03, 2025P012303
- Status last verified
- Feb 2026
- First submitted
- 3 Sep 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual-level data collected as part of the R00 study, including baseline demographics, behavioral measures, and experimental outcome variables.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches
- ClinicalTrials.gov ID
- NCT07165808
- Acronym / sponsor ID
- STUDY00009622
- Conditions
- Nicotine Addiction
- Keywords
- Nicotine Addiction, Oral Nicotine Pouches, Behavioral Responses
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 13 Feb 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 10 Sep 2025 (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 study is to assess the effects of nicotine concentration and its interplay with pH on sensory experience, product appeal, and abuse liability of NPs among young adults NP users.
Primary objective is to assess the effect of variation in nicotine concentration in nicotine pouches (NPs) and its interaction effect with pH level on three proximal outcomes of relevance to regulation: (1) sensory experience, (2) product appeal, and (3) abuse liability of NPs.
Detailed description
Oral nicotine pouches (NPs) are a rapidly growing segment of nicotine products regulated by the U.S. Food and Drug Administration (FDA). These microfiber pouches contain nicotine but no tobacco leaf, and they dissolve in the mouth without requiring spitting. Between late 2019 and early 2022, NP sales surged from 126 million to 808 million units. Their sleek packaging, concealability, and "tobacco-free" claims have made them particularly appealing to young adults, with recent studies showing that over 10% of young adults reported using NPs in the past 30 days. However, this popularity raises health concerns. NPs deliver nicotine efficiently through buccal absorption, leading to rapid increases in blood nicotine levels, which may contribute to oral toxicity, cardiovascular effects, and nicotine dependence. These factors also elevate the abuse liability of NPs-defined as the likelihood of non-medical use leading to harmful consequences.
The FDA has the authority to impose stricter regulations on products with characteristics that enhance appeal and sensory experience, especially among youth. For instance, the agency has proposed banning menthol cigarettes due to their ability to mask irritation and encourage deeper inhalation of nicotine. Similar regulatory scrutiny is now being applied to emerging products like NPs. One key factor influencing product appeal is nicotine formulation. Free-base nicotine, commonly used in non-combustible products like e-cigarettes (ECs), has aversive effects such as bitterness and airway irritation, especially at high concentrations. To counter this, manufacturers began adding organic acids to convert nicotine into a protonated salt, lowering the product's pH and improving its palatability. This shift not only enhances the sensory experience but also increases the abuse liability of high-nicotine products. Evidence suggests that regulating acid additives or setting minimum pH levels could reduce the appeal of these products. Since NPs also use acid additives to lower pH, they share similar characteristics with ECs that attract young users, underscoring the need for targeted regulatory action.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will take the intervention along two experimental factors: nicotine concentration (low [e.g., 3-4 mg] vs. high [e.g., 6-8 mg]) and pH level (low [<8.5] vs. high [≥8.5]). Each participant will be exposed to all four NP conditions in randomized order, with one condition administered per visit.
| Arm | Type | Receives |
|---|---|---|
| Nicotine Pouches group | Experimental | Other: Nicotine pouch: Low dose, Other: Nicotine pouch: High dose, Other: Low pH, Other: High pHParticipants will self-administer NPs that differ along two experimental factors: nicotine concentration (low [e.g., 3-4 mg] vs. high [e.g., 6-8 mg]) and pH level (low [<8.5] vs. high [≥8.5]). Each participant will be exposed to all four NP conditions in randomized order, with one condition administered per visit. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Current established users of nicotine pouches (have used nicotine pouches in the past 30 days \& currently use nicotine pouches every day or someday)
- Positive cotinine test via saliva test strip
- Those who are unmotivated to quit nicotine use
- Read and speak English.
- Poly-users of nicotine pouches, e-cigarettes (e.g., vape ≥20 days/month), and tobacco (e.g., ≥4 cigarettes/day for ≥2 years) will be eligible for participation
Key exclusion criteria (3 listed)
- Planning to cut down or quit using nicotine in the next 30 days
- Currently pregnant or breastfeeding
- History of stroke, seizures, high blood pressure, heart disease/problems, or cardiovascular disease contraindications for nicotine.
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 |
|---|---|---|
| Nicotine pouch: Low doseNicotine pouch: 3-4 mg | Other | Nicotine Pouches group |
| Nicotine pouch: High doseNicotine pouch: 6-8 mg | Other | Nicotine Pouches group |
| Low pHNicotine pouch with low pH level [<8.5] | Other | Nicotine Pouches group |
| High pHNicotine pouch with high pH level [>8.5] | Other | Nicotine Pouches group |
Primary outcome
Abuse liability: Amount of time with Nicotine product
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Total amount of time with Nicotine Pouches in mouth (excluding periods in between NPs after disposal)
Abuse liability: Number of Nicotine Pouches used
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Total number of Nicotine Pouches used (i.e., larger number and longer time with Nicotine Pouches, higher abuse ability.
Subjective effects measures: Drug Effects Questionnaire
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
During the session, participants will also repeatedly (every 30 min) complete the subjective effects measures of abuse liability of NP (using VAS), which will be developed based on the Drug Effects Questionnaire (DEQ). A modified version of the DEQ will be used to rate acute responses to the NP on the Visual Analogue Scale (range, 0-100). Items assess liking/wanting (e.g., "I enjoy nicotine buzz," "I feel good effects from the NP," "I want more," "I feel the NP strength," and "I like the NP effect").
Subjective effects measures: Modified Cigarette Evaluation Questionnaire
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Modified Cigarette Evaluation Questionnaire will also be used to measure domains of subjective reinforcing effects (product satisfaction, psychological reward; e.g., "NP is satisfying" on a 7-point scale (0-7).
Product appeal
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
After each administration, participants will use visual analogue scales (VAS, 0-100 range) to rate the product they just used: (1) "How much did you like the product?" (liking); (2) "How much did you dislike the product?" (disliking); and (3) "Would you use the product again?" (use again). A composite appeal score will also be calculated by averaging the 3 appeal ratings (Cronbach's α will be estimated to assess scale reliability; disliking will be reverse-scored).
Sensory Attribute
Time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)
Participants will answer following sensory quality questions: (1) "How sweet was the product?"; (2) smooth?; (3) bitter?; and (4) harsh? (VAS 0-100, "Not at all" to "Extremely". Burning and tingling sensation will be measured at each trial.
6 secondary outcomes
Nicotine product use history: Number of days
Time frame: past 30-day
Nicotine product use history: Number of Nicotine product
Time frame: past 30-day
Nicotine product use history: Amount of time with Nicotine product
Time frame: past 30-day
Nicotine Pouches brand
Time frame: past 30-day
Number of e- cigarettes
Time frame: past 30-day
Tobacco use
Time frame: past 30-day
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 27 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified individual-level data collected as part of the R00 study, including baseline demographics, behavioral measures, and experimental outcome variables.
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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.
Dae Han, PhD principal investigator
Rollins School of Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine pouch: Low dose, Nicotine pouch: High dose and Low pH in people with Nicotine Addiction, run by Emory University 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 27 Feb 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 Dae Hee Han, PhD (404-727-8742, dae.hee.han@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Abuse liability: Amount of time with Nicotine product (time frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)). The study lists 6 primary outcomes in all. 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 27 Feb 2026.