Recruiting
Phase 1

Nicotine Pouches

Sponsor:

Johns Hopkins University

Code:

NCT07128329

Conditions

Nicotine Pouch Self-Administration

Nicotine Pharmacokinetic Study

Nicotine Pharmacodynamic Study

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Nicotine Pouches

Study Details

Brief summary:

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).

Conditions

Nicotine Pouch Self-Administration

Nicotine Pharmacokinetic Study

Nicotine Pharmacodynamic Study

Study ID

NCT07128329

Start date

Nov 21, 2025

Status verified date

Feb, 2026

Completion date

Apr 1, 2027

Anticipated

Primary completion date

Apr 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Inclusion criteria (all participants):

  • greater than or equal to 21 years old
  • good general health based on screening procedures
  • vital signs in normal range (resting heart rate less than 110bpm, systolic blood pressure less than 150mmHg, diastolic blood pressure less than 100mmHg)
  • negative urine test for illicit drug use (excluding THC) and negative breath alcohol test at screening and before each session
  • no self-reported prior use of oral nicotine pouches
  • Not actively trying to quit smoking or using smoking cessation medication (e.g., nicotine replacement therapy)

Additional inclusion criteria (smokers):

  • self-report currently smoking cigarettes daily
  • exhaled breath CO greater than or equal to 10ppm and urine cotinine greater than 100 ng/ml at screening
  • meet criteria for tobacco use disorder
  • no self-reported regular use of other tobacco products (e.g., smokeless products, e-cigarettes) in the past 30 days

Additional inclusion criteria (non-nicotine users):

  • self-report previously using nicotine/tobacco but no more than 100 lifetime uses across all routes of administration
  • no self-reported nicotine/tobacco uses in the past 30 days
  • urine cotinine less than 100 ng/ml at screening.

Exclusion criteria (all participants):

  • psychoactive drug use (aside from cannabis, nicotine, alcohol, or caffeine) in past month
  • current use of OTC drugs, supplements/vitamins, or prescription medications that, in the opinion of medical staff, will impact safety
  • currently have severe dependence for cannabis
  • history of or current significant medical condition that, in the opinion of medical staff, will impact safety
  • current psychiatric condition or substance use disorder (aside from tobacco use disorder for smokers), that, in the opinion of medical staff, will impact safety
  • women who are pregnant, planning to become pregnant, or are breast-feeding

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Pouch label version 1

Nicotine pouches with label 1

experimental: Pouch label version 2

Nicotine pouches with label 2

Interventions

Nicotine Pouches

Nicotine pouches

Primary outcome measure

  • Pharmacokinetics - CMax for nicotine [ Time Frame: 6.5 hours ]
  • Pharmacokinetics - AUC for nicotine [ Time Frame: 6.5 hours ]
  • Drug Effect Questionnaire-Like Drug Effect [ Time Frame: 6.5 hours ]
  • Drug Effect Questionnaire-pleasant Drug Effect [ Time Frame: 6.5 hours ]
  • Drug Effect Questionnaire-take again [ Time Frame: 6.5 hours ]
  • Topography - number of pouches used [ Time Frame: 2 hours ]
  • Topography - duration of use [ Time Frame: 2 hours ]
  • Hughes-Hatsukami Withdrawal Questionnaire [ Time Frame: 6.5 hours ]
  • Tiffany-Drobes Questionnaire on Smoking Urges (QSU) brief [ Time Frame: 6.5 hours ]

Central Contacts and Locations

Central contacts

Joseph Ciancio, PhD

(410) 550-0529jcianci3@jh.edu

Lakshmi Kumar, PhD

(410) 550-1928lkumar6@jh.edu

Locations

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

Recruiting

Baltimore, Maryland, United States, 21224

Contacts

Joseph Ciancio

jcianci3@jh.edu

More Information

Sponsor

Johns Hopkins University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • Nicotine pouch
  • Cigarette smokers
  • Infrequent nicotine users
  • Outpatient
  • Zyn

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-02-17.