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Effects of e-Cigarettes on Perceptions and Behavior

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: NCT03742817
Recruitment Status : Suspended (Study recruitment temporarily suspended due to COVID-19 pandemic.)
First Posted : November 15, 2018
Last Update Posted : May 20, 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 across young adult e-cigarette users and middle-age/older adult smokers with an interest in, but no significant experience with, e-cigarettes; (2) Determine which dimensions of e-cigarette product diversity differentially affect abuse liability in young adult e-cigarette users and the ability to resist smoking in adult smokers with an interest in, but no significant experience with, e-cigarettes; (3) Determine the affect of product characteristics on e-cigarette nicotine delivery profile. For Aim 1, young adult vapers (N=200) and adult smokers (N=200) 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, pg/vg ratio). For Aim 2, young adults vapers (N=360) and adult smokers (N=360) will administer an e-cigarette product and complete behavioral economic tasks that test the participant's choice of earning money to delay initiation and continued use of: (1) The sampled e-cigarette product (abuse liability; young adult vapers); or (2) Their own brand cigarettes (ability to resist smoking; adult current smokers). A pilot study will establish device and e-liquid parameters (e.g., nicotine concentration) to be used for all aims.

Condition or disease Intervention/treatment Phase
Electronic Cigarettes Other: e-Cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Other
Official Title: Effects of e-Cigarettes on Perceptions and Behavior
Actual Study Start Date : February 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: Sweet-Flavor 4.5% Nicotine (Salt)
Participants will self-administer a sweet-flavored e-cigarette containing 4.5% nicotine by volume.
Other: e-Cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Placebo Comparator: Sweet-Flavor 0 mg/mL Nicotine (Free-Base)
Participants will self-administer a sweet-flavored e-cigarette containing 0 mg/mL nicotine.
Other: e-Cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Experimental: Sweet-Flavor 6 mg/mL Nicotine (Free-Base)
Participants will self-administer a sweet-flavored e-cigarette containing 6 mg/mL nicotine.
Other: e-Cigarette
Participants will self-administer an experimenter-provided e-cigarette.

Active Comparator: Usual e-Cigarette
Participants will self-administer either their preferred brand combustible cigarette or e-cigarette with usual nicotine nicotine concentration.
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 the e-cigarette administration.

  2. Positive Affect Negative Affect Schedule [ Time Frame: 4 hours ]
    The 10-item Positive Affect Negative Affect Schedule (PANAS-SF) will be used to measure positive and negative affect.

  3. Questionnaire of Vaping Urges [ Time Frame: 4 hours ]
    10-item Brief Questionnaire of Vaping Urges will assess desire, intention, urge and need to vape e-cigarettes.



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

  1. E-cigarette use >3 day/week for >2 months
  2. Report regularly using e-cigarette products with nicotine
  3. Positive cotinine test via NicAlert test strip

Smokers

  1. Daily cigarette smoking for ≥ 2 years
  2. Currently smoke > 4 cig/day
  3. Interest in trying an e-cigarette or current use of e-cigarettes

Exclusion Criteria:

Vapers

  1. Pregnancy/breastfeeding
  2. Desire to immediately reduce e-cigarette use

Smokers

  1. Breath CO < 9ppm at intake
  2. Pregnancy / breastfeeding
  3. Current daily use of other combustible tobacco products (e.g., 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): NCT03742817


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: NCT03742817    
Other Study ID Numbers: HS-18-00839 - Pilot Study
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: May 20, 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