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Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04399031
Recruitment Status : Suspended (Study recruitment temporarily suspended due to COVID-19 pandemic.)
First Posted : May 22, 2020
Last Update Posted : May 22, 2020
Sponsor:
Information provided by (Responsible Party):
Adam Leventhal, University of Southern California

Tracking Information
First Submitted Date  ICMJE May 18, 2020
First Posted Date  ICMJE May 22, 2020
Last Update Posted Date May 22, 2020
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 18, 2020)
  • Subjective Appeal [ Time Frame: 1 hour ]
    Self-report measures of product appeal will be completed following e-cigarette self-administration.
  • Sensory Appeal [ Time Frame: 1 hour ]
    Self-report measures of product appeal will be completed following e-cigarette self-administration.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
Official Title  ICMJE Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
Brief Summary This project will assess the ways in which e-cigarette product diversity impacts the user experience to inform potential regulations by identifying product characteristics that may: (1) put young adults at risk for tobacco product use; and (2) facilitate adult smokers switching to e-cigarettes. There are three primary objectives to the study: (1) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect product appeal across young adult e-cigarette users and middle-age/older adult smokers; (2) Determine which dimensions of e-cigarette product diversity differentially affect product appeal in the overall population of tobacco product users as well as affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For this substudy, young adult vapers (N=100) and adult smokers (N=100) will attend one laboratory session in which they will self-administer e-cigarette products varied according to within-subject e-cigarette factors (e.g., flavor, nicotine formulation).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Condition  ICMJE
  • Electronic Cigarette Use
  • Cigarette Use, Electronic
  • Vaping
  • Cigarette Smoking
Intervention  ICMJE Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.
Study Arms  ICMJE
  • Experimental: E-cigarette e-liquid 1
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 2
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 3
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 4
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 5
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 6
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 7
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 8
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 9
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 10
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 11
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 12
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 13
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 14
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 15
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 16
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 17
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 18
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 19
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
  • Experimental: E-cigarette e-liquid 20
    Participants will self-administer an e-cigarette e-liquid.
    Intervention: Other: E-cigarette
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: May 18, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2024
Estimated Primary Completion Date January 1, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Vapers/E-cigarette Users

  • E-cigarette/vaping device use at least three days per week for at least 2 months
  • Regular use of e-cigarettes/vaping devices containing nicotine

Cigarette Smokers

  • Daily cigarette smoking for at least two years
  • Currently smoke at least four cigarettes per day
  • Interested in trying an e-cigarette or current use of an e-cigarette

Exclusion Criteria:

Vapers/E-cigarette Users

  • Pregnant or breastfeeding
  • Desire to cut down on use of e-cigarette/vaping device

Cigarette Smokers

  • Pregnant or breastfeeding
  • Current daily use of other combustible tobacco products (such as cigars)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04399031
Other Study ID Numbers  ICMJE HS-18-00839 Substudy 1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Adam Leventhal, University of Southern California
Study Sponsor  ICMJE University of Southern California
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Adam M Leventhal, PhD University of Southern California
PRS Account University of Southern California
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP