Nicotine Pouch Self-AdministrationNCT06597435
Effects of Nicotine Pouch Characteristics on Perceptions and Behavior
A study testing Nicotine pouch in people with Nicotine Pouch Self-Administration, run by University of Southern California at 2 sites in United States.
Trial summary
There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health… Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine Pouch Self-Administration
- What is being tested?
- Nicotine pouch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Oct 2024to 31 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults age 21-35 years old.
- Current nicotine pouch users (used nicotine pouches in the past 30 days). Current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible.
- Positive cotinine test via saliva test strip.
- Unmotivated to quit nicotine use.
- English language competency (read and speak English). The instruments used have not been translated and/or validated for other languages.
Who cannot join
- Intention to quit nicotine use in the next 30 days.
- Current pregnancy or breastfeeding (urine pregnancy test will be conducted during the orientation session).
- History of stroke, seizures, high blood pressure (hypertension), heart disease/problems, lung disease/lung problems, or cardiovascular disease contraindications for nicotine.
- People under 21 years will be excluded to correspond with the legal age for purchasing tobacco products in the United States. Special subject populations will not be recruited.
Trial locations and contacts
2 sites in 1 country.
Adam Leventhal, PhD contact
United States2 sites, 2 recruiting
- Not yet recruiting
University of Southern California
Los Angeles, California, 90032
April Norambuena, 310.991.4433, norambue@usc.edu
Dae Hee Han, PhD
- Recruiting
University of Southern California - Clinical Sciences Building
Los Angeles, California, 90033
Christian Hendershot, PhD, 323-442-1082, christian.hendershot@usc.edu
Dae Hee Han, PhD
About this study
Official title: Effect of Product Characteristics on the Appeal and Sensory Attributes of Nicotine Pouches
There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. This innovative project proposes to conduct a double-blind within-subject randomized study in which participants (N = 72) will administer nicotine pouches varied by nicotine concentration (e.g., 3 vs 6 mg) and pH (e.g., 8.5 or greater vs. less than 8.5) to achieve the project aim: to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches. The findings of this proposed research will provide the U.S. Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches, which may put young adults at risk of using a novel class of oral nicotine products.
Read the detailed description
The project will assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on two proximal outcomes of relevance to regulation: (1) sensory attributes and (2) product appeal in an experimental study of young adult (21-35 years) nicotine pouch users who are unmotivated to quit nicotine use. Before the experimental session, the investigators will conduct orientation sessions where participants will confirm age, provide informed consent, and complete verification of nicotine use status by cotinine test strip. Eligible participants will be scheduled for their experimental visits and instructed to abstain from nicotine use for 8 hours (overnight) prior to the experimental session. During the experimental session, participants (N=72) will self-administer 4 different nicotine pouches varied by nicotine concentration (e.g., 3mg vs. 6mg) and pH (e.g., 8.5 or greater vs. less than 8.5) equated on other product characteristics (e.g., pouch size and weight, moisture content) in a single-visit 4-hour within-subject double-blind randomized clinical trial. Participants will rate the appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., smoothness, harshness, sweetness, bitterness, irritation) of each nicotine pouch and select their favorite nicotine pouch product (alternative appeal measure) at the end of the study. During the experimental sessions, questionnaires will also assess participants' nicotine product use characteristics and sociodemographic characteristics. After the experimental session, participants will be remunerated. Study materials will be selected among commercially available products manufactured by leading providers (e.g., ZYN, Lucy, VELO, Rogue, on!), and product constituents will be analyzed and reported. This project will identify two product characteristics (low pH and high nicotine) that may perpetuate nicotine pouch use and nicotine dependence risk by increasing their appeal and potential abuse liability in young adults, and therefore merit targeting in the U.S. Food and Drug Administration regulation.
- Conditions
- Nicotine Pouch Self-Administration
- Being tested
- Nicotine pouch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine pouchOther
Participants will self-administer an experimenter-provided nicotine pouch
| Study group | Role | What they receive |
|---|---|---|
| Nicotine pouch containing high nicotine (6-8mg) | Experimental | Participants will self-administer a nicotine pouch containing 6-8mg nicotine. Receives: Other: Nicotine pouch |
| Nicotine pouch containing low nicotine (3-4mg) | Placebo comparator | Participants will self-administer a nicotine pouch containing 3-4mg nicotine. Receives: Other: Nicotine pouch |
| Nicotine pouch with low pH (less than 8.5) | Experimental | Participants will self-administer a nicotine pouch with low pH (less than 8.5). Receives: Other: Nicotine pouch |
| Nicotine pouch with high pH (8.5 or greater) | Placebo comparator | Participants will self-administer a nicotine pouch with high pH (8.5 or greater). Receives: Other: Nicotine pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Appeal and sensory experience
Self-report measures of product appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., sweetness, smoothness, bitterness, harshness) will be completed following the nicotine pouch administration.
Measured: During the 3-hour experimental session, participant will self-administer 4 nicotine pouches, each with a 5-minute administration period. There will a 40-minute inter-product rest interval.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start31 Oct 2024
- Primary completion31 Jul 2025 (estimated)
- Study completion31 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Pouch Self-AdministrationStudies of the same condition, open and under way.
- More trials run by University of Southern CaliforniaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern California
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Dae Hee Han, University of Southern California
- Investigators
- Dae Hee Han, PhD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06597435
- Sponsor's protocol ID
- UP-23-01161
- Other IDs
- K99DA058241
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Product Characteristics on the Appeal and Sensory Attributes of Nicotine Pouches
- ClinicalTrials.gov ID
- NCT06597435
- Acronym / sponsor ID
- UP-23-01161
- Conditions
- Nicotine Pouch Self-Administration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University of Southern CaliforniaUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 31 Oct 2024 (actual)
- Primary completion
- 31 Jul 2025 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 19 Sep 2024 (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.
There is a growing sector of modern tobacco-free oral nicotine pouches that are federally regulated as non-medicinal nicotine/tobacco products. While nicotine pouches employ marketing approaches that may attract current tobacco users, such as marketing themes connoting minimal harm, information on the long-term health effects of nicotine pouches is lacking. nicotine pouches may appeal to younger adults because they are available in similar product characteristics (e.g., nicotine concentration, protonated nicotine) that many younger people prefer to use in e-cigarettes. In addition, nicotine pouches may be of particular interest to younger adult e-cigarette users because these products can be used discreetly where vaping is not allowed, which may translate into an increased likelihood of becoming dual users of e-cigarettes and nicotine pouches. Indeed, approximately 15% young adults who used e-cigarettes in the past 30 days were past 30-day nicotine pouch users. Manufacturers of modern nicotine pouches use acid additives to lower pH, which changes nicotine from a free-base to a protonated nicotine, resulting in improved appeal and sensory experience and higher abuse liability. Thus, nicotine concentration and pH in modern nicotine pouches should be focal targets for regulatory policies. Evidence is also lacking on mechanisms mediating differences in product appeal and abuse liability of nicotine pouches across products varying in nicotine concentration and pH level. The scientific objective of this research is to assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on the proximal outcomes of relevance to the U.S. Food and Drug Administration regulation: sensory attributes and product appeal among younger adults who use nicotine pouches in the past 30 days (current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible) and are unmotivated to quit nicotine use. This innovative project proposes to conduct a double-blind within-subject randomized study in which participants (N = 72) will administer nicotine pouches varied by nicotine concentration (e.g., 3 vs 6 mg) and pH (e.g., 8.5 or greater vs. less than 8.5) to achieve the project aim: to evaluate the effects of nicotine concentration and pH on subjective product appeal and sensory attributes of nicotine pouches. The findings of this proposed research will provide the U.S. Food and Drug Administration with new evidence necessary to inform regulatory restrictions on product characteristics and constituents of nicotine pouches, which may put young adults at risk of using a novel class of oral nicotine products.
Detailed description
The project will assess the effect of variation in nicotine concentration in nicotine pouches and its interaction effect with pH level on two proximal outcomes of relevance to regulation: (1) sensory attributes and (2) product appeal in an experimental study of young adult (21-35 years) nicotine pouch users who are unmotivated to quit nicotine use. Before the experimental session, the investigators will conduct orientation sessions where participants will confirm age, provide informed consent, and complete verification of nicotine use status by cotinine test strip. Eligible participants will be scheduled for their experimental visits and instructed to abstain from nicotine use for 8 hours (overnight) prior to the experimental session. During the experimental session, participants (N=72) will self-administer 4 different nicotine pouches varied by nicotine concentration (e.g., 3mg vs. 6mg) and pH (e.g., 8.5 or greater vs. less than 8.5) equated on other product characteristics (e.g., pouch size and weight, moisture content) in a single-visit 4-hour within-subject double-blind randomized clinical trial. Participants will rate the appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., smoothness, harshness, sweetness, bitterness, irritation) of each nicotine pouch and select their favorite nicotine pouch product (alternative appeal measure) at the end of the study. During the experimental sessions, questionnaires will also assess participants' nicotine product use characteristics and sociodemographic characteristics. After the experimental session, participants will be remunerated. Study materials will be selected among commercially available products manufactured by leading providers (e.g., ZYN, Lucy, VELO, Rogue, on!), and product constituents will be analyzed and reported. This project will identify two product characteristics (low pH and high nicotine) that may perpetuate nicotine pouch use and nicotine dependence risk by increasing their appeal and potential abuse liability in young adults, and therefore merit targeting in the U.S. Food and Drug Administration regulation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine pouch containing high nicotine (6-8mg) | Experimental | Other: Nicotine pouchParticipants will self-administer a nicotine pouch containing 6-8mg nicotine. |
| Nicotine pouch containing low nicotine (3-4mg) | Placebo comparator | Other: Nicotine pouchParticipants will self-administer a nicotine pouch containing 3-4mg nicotine. |
| Nicotine pouch with low pH (less than 8.5) | Experimental | Other: Nicotine pouchParticipants will self-administer a nicotine pouch with low pH (less than 8.5). |
| Nicotine pouch with high pH (8.5 or greater) | Placebo comparator | Other: Nicotine pouchParticipants will self-administer a nicotine pouch with high pH (8.5 or greater). |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults age 21-35 years old.
- Current nicotine pouch users (used nicotine pouches in the past 30 days). Current dual users of nicotine pouches and e-cigarettes and/or combustible cigarettes will be eligible.
- Positive cotinine test via saliva test strip.
- Unmotivated to quit nicotine use.
- English language competency (read and speak English). The instruments used have not been translated and/or validated for other languages.
Key exclusion criteria (4 listed)
- Intention to quit nicotine use in the next 30 days.
- Current pregnancy or breastfeeding (urine pregnancy test will be conducted during the orientation session).
- History of stroke, seizures, high blood pressure (hypertension), heart disease/problems, lung disease/lung problems, or cardiovascular disease contraindications for nicotine.
- People under 21 years will be excluded to correspond with the legal age for purchasing tobacco products in the United States. Special subject populations will not be recruited.
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 pouchParticipants will self-administer an experimenter-provided nicotine pouch | Other | Nicotine pouch containing high nicotine (6-8mg), Nicotine pouch containing low nicotine (3-4mg), Nicotine pouch with high pH (8.5 or greater), Nicotine pouch with low pH (less than 8.5) |
Primary outcome
Subjective Appeal and sensory experience
Time frame: During the 3-hour experimental session, participant will self-administer 4 nicotine pouches, each with a 5-minute administration period. There will a 40-minute inter-product rest interval.
Self-report measures of product appeal (e.g., liking, disliking, willingness to use again) and sensory attributes (e.g., sweetness, smoothness, bitterness, harshness) will be completed following the nicotine pouch administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
Related trials for Nicotine Pouch Self-Administration
RecruitingPhase 1
Acute Effects of Oral Nicotine Pouches
Nicotine Pouch Self-Administration, Nicotine Pharmacokinetic Study
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. This study is not recruiting at the moment.
Adam Leventhal, PhD contact
Dae Hee Han, PhD principal investigator
University of Southern California
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine pouch in people with Nicotine Pouch Self-Administration, run by University of Southern California at 2 sites 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 4 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: status not confirmed, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dae Hee Han, PhD (626-200-8334, daeheeha@usc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Appeal and sensory experience (time frame: During the 3-hour experimental session, participant will self-administer 4 nicotine pouches, each with a 5-minute administration period. There will a 40-minute inter-product rest interval.). 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 6 Dec 2024.