Study on Nicotine Pouch Characteristics and Their Effects
This study is looking at how different features of nicotine pouches, like the amount of nicotine (3-4 mg or 6-8 mg) and their pH level (low or high), affect how appealing they are and how likely they are to be used frequently. Researchers want to understand how these product characteristics influence your experience and use of nicotine pouches. You might be able to join if you are between 21 and 35 years old, currently use nicotine pouches daily or some days, and are not trying to quit nicotine. The study will measure how much time you spend using nicotine products and how many pouches you use, along with your subjective feelings about the products, to see what makes them more or less appealing.
- Study design
- This interventional study plans to enroll 84 participants to test different nicotine pouch characteristics. The study does not specify a phase.
- What's involved
- You will attend four visits within a 2-4 week period. During these visits, researchers will measure the amount of time you spend with nicotine products, the number of nicotine pouches you use, and your responses to a Drug Effects Questionnaire.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your participation will involve measurements taken at four visits, all within a 2-4 week period.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Dae Han, PhD · PRINCIPAL_INVESTIGATOR · Rollins School of Public Health
Who to contact
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Do you actually qualify for this trial?
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Inclusion
Exclusion
What this trial measures
- Abuse liability: Amount of time with Nicotine productVisit 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 usedVisit 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 QuestionnaireVisit 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 QuestionnaireVisit 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 appealVisit 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 AttributeVisit 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.