MedTrace Logo

Characterize the Nicotine Uptake and Subjective Effects With Use of JUUL Electronic Nicotine Delivery Systems

NCT04123041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 137

Last updated 2020-02-13

No results posted yet for this study

Summary

The purpose of this study is to estimate nicotine uptake and assess subjective effects during ad libitum use sessions of 4 flavors of JUUL ENDS (also referred to as nicotine salt pod system; NSPS) products (i.e., Virginia Tobacco, Mint, Menthol and Mango) with 2 different nicotine concentrations. Subjective effects will also be assessed to gain an understanding of the user's experience during and after JUUL ENDS product use to evaluate the abuse liability of the products. The subject population will consist of healthy adult, male and female smokers, 21 to 65 years of age.

Conditions

  • Electronic Cigarette Use
  • Tobacco Smoking

Interventions

OTHER

JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum

JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum

Sponsors & Collaborators

  • Juul Labs, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2019-09-23
Primary Completion
2019-12-18
Completion
2019-12-18

Countries

  • United States

Study Locations

More Related Trials

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 NCT04123041 on ClinicalTrials.gov