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United States Pre-Market Tobacco Application Pharmacokinetics

NCT03719391 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2021-06-14

No results posted yet for this study

Summary

A Randomized, Open-Label, Cross-Over Study to Assess Nicotine Uptake and Subjective Measures with Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) Compared to Usual Brand Combustible Cigarettes, a Comparator E-Cigarette, and Nicotine Gum in Healthy Adult Smokers

Conditions

  • Nicotine Dependence
  • Nicotine Dependence, Cigarettes
  • Tobacco Use
  • Tobacco Smoking

Interventions

OTHER

Virginia Tobacco flavored JUUL 5% ENDS

Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).

OTHER

Cool Mint flavored JUUL 5% ENDS

Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).

OTHER

Mango flavored JUUL 5% ENDS

Treatment with Mango flavored JUUL 5% ENDS (10 puffs).

OTHER

Creme Brulee flavored JUUL 5% ENDS

Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).

OTHER

VUSE Solo e-cigarette

Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).

OTHER

Nicorette White Ice Mint 4mg nicotine polacrilex gum

Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)

OTHER

Usual Brand combustible cigarette

Treatment with usual brand cigarette (10 puffs).

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
2018-10-19
Primary Completion
2018-11-21
Completion
2018-11-28

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 NCT03719391 on ClinicalTrials.gov