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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

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).

Condition or disease Intervention/treatment Phase
Electronic Cigarette Use Cigarette Use, Electronic Vaping Cigarette Smoking Other: E-cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Effects of e-Cigarettes on Perceptions and Behavior - Substudy 1
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : January 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: E-cigarette e-liquid 1
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 2
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 3
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 4
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 5
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 6
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 7
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 8
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 9
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 10
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 11
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 12
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 13
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 14
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 15
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 16
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 17
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 18
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 19
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: E-cigarette e-liquid 20
Participants will self-administer an e-cigarette e-liquid.
Other: E-cigarette
Participants will self-administer an experimenter-provided e-cigarette.




Primary Outcome Measures :
  1. Subjective Appeal [ Time Frame: 1 hour ]
    Self-report measures of product appeal will be completed following e-cigarette self-administration.

  2. Sensory Appeal [ Time Frame: 1 hour ]
    Self-report measures of product appeal will be completed following e-cigarette self-administration.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04399031


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Investigators
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Principal Investigator: Adam M Leventhal, PhD University of Southern California
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Responsible Party: Adam Leventhal, Professor of Preventive Medicine, University of Southern California
ClinicalTrials.gov Identifier: NCT04399031    
Other Study ID Numbers: HS-18-00839 Substudy 1
First Posted: May 22, 2020    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No