NCT03593239

Brief Summary

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

June 29, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 26, 2018

Completed
Last Updated

June 21, 2021

Status Verified

June 1, 2021

Enrollment Period

27 days

First QC Date

June 1, 2018

Last Update Submit

June 15, 2021

Conditions

Nicotine DependenceNicotine Dependence, CigarettesTobacco UseTobacco Smoking

Keywords

Electronic Nicotine Delivery SystemCombustible CigarettesNicotine

Outcome Measures

Primary Outcomes (4)

  • Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Time to Maximum Concentration(Tmax)

    Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).

    38 Days

  • Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Concentration Maximum (Cmax)

    Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).

    38 Days

  • Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring Cmax-baseline and Area Under the Curve ( AUC) 1hour

    Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).

    38 Days

  • Compare nicotine pharmacokinetics(PK) in smokers and e-cigarette users measuring AUC1hour-baseline of nicotine

    Compare nicotine pharmacokinetics (PK) in smokers and e-cigarette users, obtained with: Tobacco flavored JUUL 1.7% ENDS (10 puffs); Tobacco flavored JUUL 5% ENDS (10 puffs); Mint flavored JUUL 1.7% ENDS (10 puffs); Mint flavored JUUL 5% ENDS (10 puffs); Fruit Medley flavored JUUL 1.7% ENDS (10 puffs); Fruit Medley flavored JUUL 5% ENDS (10 puffs); Crème brulee flavored JUUL 1.7% ENDS (10 puffs); Crème brulee flavored JUUL 5% ENDS (10 puffs).

    38 Days

Secondary Outcomes (2)

  • Change in Pre and Post exhaled carbon monoxide (CO) values for each subject and Test Product.

    38 Days

  • To compare user satisfaction measures of each Test Product when consumed by smokers and e-cigarette users.

    38 Days

Study Arms (10)

Tobacco flavored JUUL 1.7% ENDS

EXPERIMENTAL

Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Other: Tobacco flavored JUUL 1.7% ENDS

Tobacco flavored JUUL 5% ENDS

EXPERIMENTAL

Tobacco flavored JUUL 5% ENDS (10 puffs)

Other: Tobacco flavored JUUL 5% ENDS

Mint flavored JUUL 1.7% ENDS

EXPERIMENTAL

Mint flavored JUUL 1.7% ENDS (10 puffs);

Other: Mint flavored JUUL 1.7% ENDS

Mint flavored JUUL 5% ENDS

EXPERIMENTAL

Mint flavored JUUL 5% ENDS (10 puffs)

Other: Mint flavored JUUL 5% ENDS

Fruit Medley flavored JUUL 1.7% ENDS

EXPERIMENTAL

Fruit Medley flavored JUUL 1.7% ENDS (10 puffs)

Other: Fruit Medley flavored JUUL 1.7% ENDS

Fruit Medley flavored JUUL 5% ENDS

EXPERIMENTAL

Fruit Medley flavored JUUL 5% ENDS (10 puffs)

Other: Fruit Medley flavored JUUL 5% ENDS

Crème brulee flavored JUUL 1.7% ENDS

EXPERIMENTAL

Crème brulee flavored JUUL 1.7% ENDS (10 puffs)

Other: Crème brulee flavored JUUL 1.7% ENDS

Crème brulee flavored JUUL 5% ENDS

EXPERIMENTAL

Crème brulee flavored JUUL 5% ENDS (10 puffs)

Other: Crème brulee flavored JUUL 5% ENDS

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

EXPERIMENTAL

Tobacco flavoured JUUL 1.7% ENDS products 10 puffs versus ad libitum puffs

Other: JUUL 1.7% ENDS 10 puffs vs. ad lib puffs

JUUL 5% ENDS 10 puffs vs. ad lib puffs

EXPERIMENTAL

Tobacco flavoured JUUL 5% ENDS products 10 puffs versus ad libitum puffs

Other: JUUL 5% ENDS 10 puffs vs. ad lib puffs

Interventions

Tobacco flavored JUUL 1.7% ENDSOTHER

Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)

Tobacco flavored JUUL 1.7% ENDS
Tobacco flavored JUUL 5% ENDSOTHER

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

Tobacco flavored JUUL 5% ENDS
Mint flavored JUUL 1.7% ENDSOTHER

Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)

Mint flavored JUUL 1.7% ENDS
Mint flavored JUUL 5% ENDSOTHER

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

Mint flavored JUUL 5% ENDS
Fruit Medley flavored JUUL 1.7% ENDSOTHER

Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)

Fruit Medley flavored JUUL 1.7% ENDS
Fruit Medley flavored JUUL 5% ENDSOTHER

Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)

Fruit Medley flavored JUUL 5% ENDS
Crème brulee flavored JUUL 1.7% ENDSOTHER

Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)

Crème brulee flavored JUUL 1.7% ENDS
Crème brulee flavored JUUL 5% ENDSOTHER

Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)

Crème brulee flavored JUUL 5% ENDS
JUUL 1.7% ENDS 10 puffs vs. ad lib puffsOTHER

Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs

JUUL 1.7% ENDS 10 puffs vs. ad lib puffs
JUUL 5% ENDS 10 puffs vs. ad lib puffsOTHER

Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs

JUUL 5% ENDS 10 puffs vs. ad lib puffs

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female aged 18 to 60 years of age inclusive.
  • Current smoker or e-cigarette user:
  • Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

You may not qualify if:

  • Clinically significant abnormality on screening ECG.
  • Sustained blood pressure recordings at screening of \< 90 mmHg or \> 150 mmHg for systolic blood pressure, or \< 50 mmHg or \> 90 mmHg for diastolic blood pressure.
  • Sustained resting heart rate of \> 100 or \< 40 beats per minute at screening.
  • Positive result for urine drugs of abuse test or alcohol breath test at screening.
  • Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
  • Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential.
  • Any clinically significant concomitant disease or conditions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christchurch Clinical Studies Trust Ltd

Christchurch, 8011, New Zealand

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco UseTobacco SmokingVaping

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorSmoking

Study Officials

  • Christopher Wynne, MD

    Christchurch Clinical Studies Trust Ltd

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2018

First Posted

July 20, 2018

Study Start

June 29, 2018

Primary Completion

July 26, 2018

Study Completion

July 26, 2018

Last Updated

June 21, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

NZ(1)