Acute Effects of Oral Nicotine Pouches

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07128329
Phase
PHASE1
Status
Recruiting
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Conditions

  • Nicotine Pharmacodynamic Study
  • Nicotine Pharmacokinetic Study
  • Nicotine Pouch Self-Administration

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Nicotine Pouches — DRUG
    Nicotine pouches

Study Details

The present human laboratory study will recruit cigarette smokers (n=60) and adult infrequent nicotine users (n=60) to complete two counterbalanced lab sessions in which the participants use nicotine pouches under controlled conditions. The investigators are recruiting both frequent and infrequent nicotine users because FDA regulates tobacco products based on a public health standard, meaning FDA must consider the impact a regulation may have on the population as a whole (e.g., people who use and do not use tobacco products currently).

Key Dates

Start date
Nov 21, 2025
Status verified
Feb 2026
Primary completion
Apr 1, 2027
Completion
Apr 1, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Pouch label version 1
    Nicotine pouches with label 1
  • Experimental: Pouch label version 2
    Nicotine pouches with label 2

Primary Outcome Measure

Pharmacokinetics - CMax for nicotine [ Time Frame: 6.5 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)BaltimoreMaryland21224
Joseph Ciancio
[email protected]

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Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview)· Baltimore, MD

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