Recruiting

Nicotine Pouches

Sponsor:

Emory University

Code:

NCT07165808

Conditions

Nicotine Addiction

Eligibility Criteria

Sex: All

Age: 21 - 35

Healthy Volunteers: Accepted

Interventions

Nicotine pouch: Low dose

Nicotine pouch: High dose

Low pH

High pH

Study Details

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

Study ID

NCT07165808

Start date

Feb 13, 2026

Status verified date

Feb, 2026

Completion date

Jan, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 35

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

84 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Nicotine Pouches group

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.

Interventions

Nicotine pouch: Low dose

Nicotine pouch: 3-4 mg

Nicotine pouch: High dose

Nicotine pouch: 6-8 mg

Low pH

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

High pH

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

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) ]
  • Abuse liability: Number of Nicotine Pouches used [ Time Frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks) ]
  • Subjective effects measures: Drug Effects Questionnaire [ Time Frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks) ]
  • Subjective effects measures: Modified Cigarette Evaluation Questionnaire [ Time Frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks) ]
  • Product appeal [ Time Frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks) ]
  • Sensory Attribute [ Time Frame: Visit 1, Visit 2, Visit 3, Visit 4 (all visits within 2-4 weeks) ]

Central Contacts and Locations

Central contacts

Dae Hee Han, PhD

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

Locations

Rollins School of Public Health

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Feb 27, 2026

Last verified

Feb, 2026

Keywords

  • Nicotine Addiction
  • Oral Nicotine Pouches
  • Behavioral Responses

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-02-27.