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NCT07128329 · ClinicalTrials.gov registry record · Phase 1
Acute Effects of Oral Nicotine Pouches
A Phase 1 study of Nicotine Pouch Self-Administration and Nicotine Pharmacokinetic Study, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT07128329: Recruiting Phase 1 study of Nicotine Pouch Self-Administration and Nicotine Pharmacokinetic Study, sponsored by Johns Hopkins University.
NCT07128329 is a Phase 1 study of Nicotine Pouch Self-Administration and Nicotine Pharmacokinetic Study that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07128329, a Phase 1 study of Nicotine Pouch Self-Administration and Nicotine Pharmacokinetic Study, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Blood plasma samples will be collected and sent to a designated laboratory for quantitative analysis of nicotine. Maximum concentration (Cmax), is the highest plasma nicotine concentration reached during a session and provides important insight into the abuse liability of a tobacco product.
Conditions Studied
Interventions
- DRUG Nicotine Pouches
Study Locations (1)
Maryland
- Johns Hopkins University School of Medicine, Behavioral Pharmacology Research Unit (Bayview) - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2025-11-21 |
| Est. Completion | 2027-04-01 |
| Phase | Phase 1 |
What NCT07128329 shows while recruiting
NCT07128329 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 3 conditions, with Nicotine Pouch Self-Administration appearing as the primary indexed condition, and to 1 intervention - of which Nicotine Pouches is the first listed.
NCT07128329 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT07128329 about?
NCT07128329 is a clinical study titled "Acute Effects of Oral Nicotine Pouches". 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 n...
What is the current status of trial NCT07128329?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2025-11-21. Estimated completion is 2027-04-01.
What conditions does trial NCT07128329 study?
This clinical trial studies the following conditions: Nicotine Pouch Self-Administration, Nicotine Pharmacokinetic Study, Nicotine Pharmacodynamic Study.
What interventions are being tested in trial NCT07128329?
The interventions under investigation include: Nicotine Pouches (DRUG).
Who is sponsoring clinical trial NCT07128329?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07128329 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Nicotine Pouch Self-Administration
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07128329's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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