Clinical Trial

Acute Effects of Oral Nicotine Pouches

Recruiting Phase 1
View on ClinicalTrials.gov →
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).
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2025-08-13; most recent amendment 2026-02-13.
Status change: Not Yet Recruiting → Recruiting 2025-11-21
Trial Details
NCT Number NCT07128329
Lead Sponsor Johns Hopkins University
Collaborators: National Institute on Drug Abuse (NIDA)
Conditions Nicotine Pouch Self-Administration, Nicotine Pharmacokinetic Study, Nicotine Pharmacodynamic Study
Enrollment 120 participants
Start Date 2025-11-21
Primary Completion 2027-04-01 (estimated)
Study Completion 2027-04-01 (estimated)
Updated on ClinicalTrials.gov 2026-02-17