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NCT04104152 · ClinicalTrials.gov registry record · NA

CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting

A NA study, sponsored by RAI Services Company.

Completed
Registry status
NA
Development phase
146
Enrollment target

NCT04104152: Completed NA study, sponsored by RAI Services Company.

NCT04104152 is a NA study that has completed, run by RAI Services Company. The registered enrollment target is 146 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04104152, a NA study, has completed, sponsored by RAI Services Company.

COMPLETED
Registry status
NA
Development phase
146 participants
Enrollment target

Study Summary

This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy adult ENDS users. This study will be conducted for potential submission to the US Food and Drug Administration (FDA) Center for Tobacco Products (CTP) as part of a Premarket Tobacco Product Application (PMTA) for an Electronic Nicotine Delivery System (ENDS), comprised of an electrical power unit and four flavor variants each with two different levels of nicotine (2.4% and 5.0%).

Primary Outcome

Arithmetic Mean puff duration for 5.0% nicotine and 2.4% nicotine ENDS products across the final two weeks of data collection

Interventions

  • OTHER CSD1902-11
  • OTHER CSD1902-12
  • OTHER CSD1902-13
  • OTHER CSD1902-14
  • OTHER CSD1902-21

Trial Details

FieldValue
Enrollment Target 146 participants
Start Date 2019-10-07
Est. Completion 2020-03-06
Phase NA
RAI Services Company

42 total trials

What the finished NCT04104152 record still lists

NCT04104152 is an interventional study that assigns participants to a tested intervention. The registered 146 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).

The record links to 0 conditions, and to 5 interventions - of which CSD1902-11 is the first listed.

NCT04104152 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04104152 about?

NCT04104152 is a clinical study titled "CSD190203: A Study to Determine Subject Puffing Patterns of an Electronic Nicotine Delivery System in an Ambulatory Setting". This study will be a single-center, randomized, controlled, open-label, parallel 2-cohort study to evaluate the puffing patterns of individuals switching from a similar usual brand (UB) Electronic Nicotine Delivery System (ENDS) product to either a 2.4% or 5% nicotine level ENDS product in healthy a...

What is the current status of trial NCT04104152?

This trial is currently completed. It is a NA study. The enrollment target is 146 participants. The study started on 2019-10-07. Estimated completion is 2020-03-06.

What interventions are being tested in trial NCT04104152?

The interventions under investigation include: CSD1902-11 (OTHER), CSD1902-12 (OTHER), CSD1902-13 (OTHER), CSD1902-14 (OTHER), CSD1902-21 (OTHER).

Who is sponsoring clinical trial NCT04104152?

This trial is sponsored by RAI Services Company, which has 42 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04104152's enrollment target sits among peer trials

146 704th of 2000 higher than 1,296 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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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Source: ClinicalTrials.gov NCT04104152, the US trial registry maintained by the National Library of Medicine. NCT04104152 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.