NCT03719391

Brief 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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

October 17, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

October 19, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 25, 2018

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2018

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2018

Completed
Last Updated

June 14, 2021

Status Verified

January 1, 2019

Enrollment Period

1 month

First QC Date

October 17, 2018

Last Update Submit

June 10, 2021

Conditions

Nicotine DependenceNicotine Dependence, CigarettesTobacco UseTobacco Smoking

Keywords

Electronic Nicotine Delivery SystemCombustible CigarettesNicotine

Outcome Measures

Primary Outcomes (1)

  • To assess nicotine uptake during a 10-puff controlled use of four JUUL 5% electronic nicotine delivery systems (ENDS) relative to usual brand (UB) combustible cigarettes, a comparator electronic cigarette (e-cigarette), and nicotine gum.

    Nicotine PK parameters will be calculated from the individual plasma concentrations per details provided in the SAP. Baseline adjustments to the (non-adjusted) PK endpoints will also be presented.

    7 days

Secondary Outcomes (10)

  • To assess exhaled carbon monoxide [CO] following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum

    7 Days

  • To assess measures of subjective effects with controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum using the "modified Product Evaluation Scale (mPES)"

    7 Days

  • To assess blood pressure following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.

    7 Days

  • To assess heart rate following controlled use of four JUUL 5% ENDS relative to UB combustible cigarettes, a comparator e-cigarette, and nicotine gum.

    7 Days

  • To assess the safety and tolerability of short-term use of four JUUL 5% ENDS.

    7 Days

  • +5 more secondary outcomes

Study Arms (7)

JUUL 5% Virginia Tobacco ENDS

EXPERIMENTAL

Treatment with JUUL Virginia Tobacco flavored 5.0% ENDS product.

Other: Virginia Tobacco flavored JUUL 5% ENDS

JUUL 5% Cool Mint ENDS

EXPERIMENTAL

Treatment with JUUL Cool Mint flavored 5.0% ENDS product.

Other: Cool Mint flavored JUUL 5% ENDS

JUUL 5% Mango ENDS

EXPERIMENTAL

Treatment with JUUL Mango flavored 5.0% ENDS product.

Other: Mango flavored JUUL 5% ENDS

JUUL 5% Creme Brulee ENDS

EXPERIMENTAL

Treatment with JUUL Creme Brulee flavored 5.0% ENDS product.

Other: Creme Brulee flavored JUUL 5% ENDS

VUSE Solo e-cigarette

ACTIVE COMPARATOR

Treatment with VUSE Solo Original with 4.8% nicotine product.

Other: VUSE Solo e-cigarette

Nicotine Gum

ACTIVE COMPARATOR

Treatment with nicorette white ice mint 4mg nicotine polacrilex gum product.

Other: Nicorette White Ice Mint 4mg nicotine polacrilex gum

Usual Brand Combustible Cigarette

ACTIVE COMPARATOR

Treatment with usual brand combustible cigarette.

Other: Usual Brand combustible cigarette

Interventions

Virginia Tobacco flavored JUUL 5% ENDSOTHER

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

Also known as: JUUL
JUUL 5% Virginia Tobacco ENDS
Cool Mint flavored JUUL 5% ENDSOTHER

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

Also known as: JUUL
JUUL 5% Cool Mint ENDS
Mango flavored JUUL 5% ENDSOTHER

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

Also known as: JUUL
JUUL 5% Mango ENDS
Creme Brulee flavored JUUL 5% ENDSOTHER

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

Also known as: JUUL
JUUL 5% Creme Brulee ENDS
VUSE Solo e-cigaretteOTHER

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

Also known as: VUSE
VUSE Solo e-cigarette
Nicorette White Ice Mint 4mg nicotine polacrilex gumOTHER

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

Also known as: Nicotine Gum
Nicotine Gum
Usual Brand combustible cigaretteOTHER

Treatment with usual brand cigarette (10 puffs).

Usual Brand Combustible Cigarette

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy, adult, male or female smoker, 21 to 65 years of age, inclusive
  • Has been a smoker for at least 12 months prior to Screening. Brief periods of non-smoking (e.g., up to \~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) during that time will be permitted at the discretion of the PI.
  • Currently smokes an average of 10 or more king size or 100s manufactured combustible CPD, as reported at Screening.
  • Has a positive urine cotinine (≥ 500 ng/mL) at Screening
  • Has an exhaled CO \> 12 ppm at Screening.
  • Is willing to comply with the requirements of the study, including a willingness to use the study products during the study.

You may not qualify if:

  • Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the PI, would jeopardize the safety of the subject or impact the validity of the study results.
  • Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
  • Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening.
  • Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment within 14 days prior to Check-in.
  • Has a fever (\> 100.5°F) at Screening or Check-in.
  • Has a body mass index (BMI) \> 40.0 kg/m2 or \< 18.0 kg/m2 at Screening.
  • Has a history of drug or alcohol abuse within 24 months of Check-in, as determined by the PI.
  • Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease.
  • Has a systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 40 mmHg or \> 95 mmHg, or heart rate \< 40 bpm or \> 99 bpm at Screening.
  • Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the e-liquids (benzoic acid, propylene glycol and glycerol).
  • Has an estimated creatinine clearance \< 80 mL/minute (using the Cockcroft-Gault equation) at Screening.
  • Has a positive urine screen for alcohol or drugs of abuse at Screening or Check-in.
  • Has used medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to Check-in.
  • Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 14 days prior to Check-in.
  • Has a prior history of JUUL product use prior to Screening
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vince & Associates Clinical Research

Overland Park, Kansas, 66212, United States

Location

Related Publications (7)

  • Jensen RP, Luo W, Pankow JF, Strongin RM, Peyton DH. Hidden formaldehyde in e-cigarette aerosols. N Engl J Med. 2015 Jan 22;372(4):392-4. doi: 10.1056/NEJMc1413069. No abstract available.

    PMID: 25607446BACKGROUND

  • D'Ruiz CD, Graff DW, Robinson E. Reductions in biomarkers of exposure, impacts on smoking urge and assessment of product use and tolerability in adult smokers following partial or complete substitution of cigarettes with electronic cigarettes. BMC Public Health. 2016 Jul 11;16:543. doi: 10.1186/s12889-016-3236-1.

    PMID: 27401980BACKGROUND

  • McNeill A et al. E-cigarettes: An Evidence Update. A report commissioned by Public Health England. Available at: https://www.gov.uk/government/uploads/system/uploads/ attachment_data/file/457102/Ecigarettes_an_evidence_update_A_report_commissioned_by_ Public_Health_England_FINAL.pdf (Aug 2015).

    BACKGROUND

  • Polosa R, Morjaria J, Caponnetto P, Caruso M, Strano S, Battaglia E, Russo C. Effect of smoking abstinence and reduction in asthmatic smokers switching to electronic cigarettes: evidence for harm reversal. Int J Environ Res Public Health. 2014 May 8;11(5):4965-77. doi: 10.3390/ijerph110504965.

    PMID: 24814944BACKGROUND

  • Fagerstrom K. Determinants of tobacco use and renaming the FTND to the Fagerstrom Test for Cigarette Dependence. Nicotine Tob Res. 2012 Jan;14(1):75-8. doi: 10.1093/ntr/ntr137. Epub 2011 Oct 24. No abstract available.

    PMID: 22025545BACKGROUND

  • Hatsukami DK, Zhang Y, O'Connor RJ, Severson HH. Subjective responses to oral tobacco products: scale validation. Nicotine Tob Res. 2013 Jul;15(7):1259-64. doi: 10.1093/ntr/nts265. Epub 2012 Dec 13.

    PMID: 23239843BACKGROUND

  • HIPAA Privacy Rule. Information for Researchers. De-identifying Protected Health Information Under the Privacy Rule. U.S. Department of Health and Human Services. NIH (Feb 2007). Available at: http://privacyruleandresearch.nih.gov/pr_08.asp#8a. Last accessed 31-Jul-2017.

    BACKGROUND

MeSH Terms

Conditions

Tobacco Use DisorderTobacco UseTobacco SmokingVaping

Interventions

Nicotine Chewing Gum

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehaviorSmoking

Intervention Hierarchy (Ancestors)

Chewing GumPlant GumsBiopolymersPolymersMacromolecular SubstancesPolysaccharidesCarbohydratesTobacco Use Cessation DevicesTherapeuticsCandyFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: Randomized, Open-Label, Cross-Over
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2018

First Posted

October 25, 2018

Study Start

October 19, 2018

Primary Completion

November 21, 2018

Study Completion

November 28, 2018

Last Updated

June 14, 2021

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)