Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05335915 · ClinicalTrials.gov registry record · Phase 1
Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers
A Phase 1 study, sponsored by Johns Hopkins University.
- Completed
- Registry status
- Phase 1
- Development phase
- 71
- Enrollment target
NCT05335915: Completed Phase 1 study, sponsored by Johns Hopkins University.
NCT05335915 is a Phase 1 study that has completed, run by Johns Hopkins University. The registered enrollment target is 71 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05335915, a Phase 1 study, has completed, sponsored by Johns Hopkins University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 71 participants
- Enrollment target
Study Summary
The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosing conditions: tobacco-flavored pouch (low or high nicotine dose), mint/menthol-flavored pouch (low or high nicotine dose), and fruit-flavored pouch (low or high nicotine dose); participants will also complete a condition where the participants will smoke participants' preferred brand of cigarettes. In each experimental session, participants will complete 2 product-use bouts. In bout 1, the participants will use a single product (pouch or cigarette) for a fixed period under controlled conditions. In bout 2, participants will be given 2 hours to use participants' assigned product ad libitum.
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. Bout 1 (20min directed use) Cmax was calculated based on post-baseline blood timepoints which include 10 minutes, 20 minutes, 30 minutes, and 1 hour after bout 1 dosing.
Interventions
- OTHER Cigarette
- OTHER Nicotine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2022-07-27 |
| Est. Completion | 2025-08-29 |
| Phase | Phase 1 |
What the finished NCT05335915 record still lists
NCT05335915 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (18% higher).
The record links to 0 conditions, and to 2 interventions - of which Cigarette is the first listed.
NCT05335915 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05335915 about?
NCT05335915 is a clinical study titled "Acute Pharmacokinetic and Pharmacodynamic Effects of "Tobacco-Free" Oral Nicotine Pouches in Smokers". The purpose of the present study is to examine the pharmacokinetics and pharmacodynamics of "tobacco-free" oral nicotine pouches, at various doses and flavors, in healthy adult smokers. The study will utilize a within-subjects, double-blind design. Upon enrollment, participants will complete 7 dosin...
What is the current status of trial NCT05335915?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 71 participants. The study started on 2022-07-27. Estimated completion is 2025-08-29.
What interventions are being tested in trial NCT05335915?
The interventions under investigation include: Cigarette (OTHER), Nicotine (OTHER).
Who is sponsoring clinical trial NCT05335915?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05335915's enrollment target sits among peer trials
71 747th of 2000 higher than 1,252 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05452889 · 71 participants · Early Phase 1
PET Image in PAH Patients
- NCT05766943 · 71 participants · NA
Reduction of Myopotential Interference With Smart Pass in S-ICD Patients
- NCT06229678 · 71 participants · Early Phase 1
Ketones, SGLT2, HFrEF
- NCT06377566 · 71 participants · Phase 2
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI