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

NCT04104152 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2022-06-27

No results posted yet for this 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%).

Conditions

  • Smoking
  • Smoking Behaviors
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

CSD1902-11

A 2.4% nicotine ENDS product

OTHER

CSD1902-12

A 2.4% nicotine ENDS product

OTHER

CSD1902-13

A 2.4% nicotine ENDS product

OTHER

CSD1902-14

A 2.4% nicotine ENDS product

OTHER

CSD1902-21

A 5.0% nicotine ENDS product

OTHER

CSD1902-22

A 5.0% nicotine ENDS product

OTHER

CSD1902-23

A 5.0% nicotine ENDS product

OTHER

CSD1902-24

A 5.0% nicotine ENDS product

Sponsors & Collaborators

  • RAI Services Company

    lead INDUSTRY

Principal Investigators

  • Jeff Smith, PhD · RAIS

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-07
Primary Completion
2020-03-06
Completion
2020-03-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04104152 on ClinicalTrials.gov