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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. 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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05335915
The ClinicalTrials.gov registry entry for NCT05335915 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Johns Hopkins University, which has 1,448 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Cigarette is the first listed.
NCT05335915 reports 0 study locations.
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.
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