Effect of Product Characteristics on the Abuse Liability of Nicotine Pouches

NCT07165808 | Recruiting

• 3 other identifiers: STUDY00009622R00DA058241-032025P012303
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Nicotine Addiction

Keywords

Nicotine Addiction; Oral Nicotine Pouches; Behavioral Responses

Outcome Measures

Primary Outcomes (6)

• Abuse liability: Amount of time with Nicotine product

  Total amount of time with Nicotine Pouches in mouth (excluding periods in between NPs after disposal)

  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.

  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").

  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).

  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).

  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.

  Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks)

Secondary Outcomes (6)

• Nicotine product use history: Number of days

  past 30-day

• Nicotine product use history: Number of Nicotine product

  past 30-day

• Nicotine product use history: Amount of time with Nicotine product

  past 30-day

• Nicotine Pouches brand

  past 30-day

• Number of e- cigarettes

  past 30-day

Other Outcomes (1)

• Salivary cotinine

  Baseline

Study Arms (1)

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.

Other: Nicotine pouch: Low dose; Other: Nicotine pouch: High dose; Other: Low pH; Other: High pH

Interventions

Nicotine pouch: Low dose OTHER

Nicotine pouch: 3-4 mg

Nicotine Pouches group

Nicotine pouch: High dose OTHER

Nicotine pouch: 6-8 mg

Nicotine Pouches group

Low pH OTHER

Nicotine pouch with low pH level \[\<8.5\]

Nicotine Pouches group

High pH OTHER

Nicotine pouch with high pH level \[\>8.5\]

Nicotine Pouches group

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Emory University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Rollins School of Public Health

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

pHLIP protein

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Dae Han, PhD

  Rollins School of Public Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae Hee Han, PhD

CONTACT

404-727-8742; dae.hee.han@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant and Investigator will remain blinded to the intervention dose and pH
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: September 3, 2025
• First Posted: September 10, 2025
• Study Start: February 13, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will become available within 12 months after publication of the primary study results and will remain available for at least 3 years thereafter.
• Access Criteria: Data will be shared through a secure, controlled-access repository. Researchers must submit a data use request, obtain approval from the principal investigator, and sign a data use agreement to ensure protection of participant confidentiality and compliance with IRB and NIH policies

Locations

US (1)