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Trial record 2 of 77 for:    e-juices and nicotine
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The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers

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ClinicalTrials.gov Identifier: NCT03186911
Recruitment Status : Withdrawn (Study team decided not to move forward with study)
First Posted : June 14, 2017
Last Update Posted : August 5, 2019
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Wake Forest University Health Sciences

Study Description
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Brief Summary:
Participants will complete a phone screen and then one laboratory session. After completing in-person screening assessments, eligible participants will complete additional questionnaires. Participants will then choose an e-liquid flavor to use for the rest of the session. Participants will then sample two e-liquids that vary in nicotine content from little or no nicotine to a moderate level of nicotine, and questionnaires evaluating the subjective effects of each one. Participants will then complete a preference assessment where they choose between the two e-liquids. Participants will be blind to the nicotine contents.

Condition or disease Intervention/treatment Phase
Tobacco Use Behavioral: E-liquid sampling and preference assessment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Impact of E-liquid Nicotine Content on Reinforcement in Current Smokers
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019
Arms and Interventions
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Arm Intervention/treatment
E-liquid Group
Participants will sample two different e-liquids.
 Behavioral: E-liquid sampling and preference assessment
Participants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task.


Outcome Measures
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Primary Outcome Measures :
  1. Product Evaluation Questionnaire [ Time Frame: One Day ]
    Ratings of the two e-liquids on a self-report questionnaire


Secondary Outcome Measures :
  1. Preference Assessment [ Time Frame: One Day ]
    Choices of each of the two e-liquids on a preference assessment

  2. Perceived Health Risk Questionnaire [ Time Frame: One Day ]
    Personal Health Risk Ratings about each of the two e-liquids

  3. Vaping Purchase Task [ Time Frame: One Day ]
    Hypothetical estimates of consumption of each of the e-liquids across a variety of prices


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Daily cigarette smoking
  • Have tried vaping devices on a minimum of one lifetime occasion

Exclusion Criteria:

  • Unwilling to use a vaping device during the session
  • Break alcohol level > 0.01 (g/dL)
  • Pregnant, trying to become pregnant, or breastfeeding
  • Systolic BP greater than or equal to 160 mm/Hg or below 90 mm/Hg
  • Diastolic BP greater than or equal to 100 mm/Hg or below 50 mm/Hg
  • Heart rate greater than or equal to 105 bpm or lower than 45 bpm
  • A current upper respiratory infection, recent cardiac event (in the last year), Buerger disease, irregular heartbeat or arrhythmia within the last year, previous allergic or adverse reaction to nicotine
Contacts and Locations
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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): NCT03186911


Sponsors and Collaborators
Wake Forest University Health Sciences
National Institute on Drug Abuse (NIDA)
Investigators
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Principal Investigator: Eric C Donny, PhD Wake Forest University Health Sciences
More Information
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Responsible Party: Wake Forest University Health Sciences
ClinicalTrials.gov Identifier: NCT03186911    
Other Study ID Numbers: U54 DA031659-06 Pilot
1U54DA031659-01 ( U.S. NIH Grant/Contract )
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: August 5, 2019
Last Verified: October 2018
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