NCT07165808 · Emory University
Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches
What this study is about
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.
View original scientific description
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.
Interventions
OTHER
Nicotine pouch: Low dose
Nicotine pouch: 3-4 mg
OTHER
Nicotine pouch: High dose
Nicotine pouch: 6-8 mg
OTHER
Low pH
Nicotine pouch with low pH level \[\<8.5\]
OTHER
High pH
Nicotine pouch with high pH level \[\>8.5\]
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Atlanta, Georgia
Collaborators
National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 27, 2026 · Source of record for eligibility and locations