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Assessing Electronic Cigarette Nicotine Flux

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ClinicalTrials.gov Identifier: NCT04378907
Recruitment Status : Recruiting
First Posted : May 7, 2020
Last Update Posted : February 11, 2021
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Tracking Information
First Submitted Date  ICMJE April 30, 2020
First Posted Date  ICMJE May 7, 2020
Last Update Posted Date February 11, 2021
Actual Study Start Date  ICMJE January 5, 2021
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Plasma Nicotine Concentration [ Time Frame: Approximately 205 minutes ]
    Change in plasma nicotine concentration Blood will be taken 5 times in each session to examine changes from baseline (approx. 90 minutes) to immediately follow a ten-puff bout (approx. 100, 120, and 190 minutes), and immediately after the cigarette challenge paradigm (approx. 205 minutes).
  • Cigarette Challenge Paradigm [ Time Frame: This task will occur at approximiately 200 minutes until 205 minutes ]
    The cigarette challenge paradigm is a procedure in which participants will be given a 5 minute time period in which they are allowed to smoke their own brand cigarette as much or as little as they want. Study staff will provide the participant with their own brand cigarettes, a lighter, and an ash tray. Latency to start the first puff and number of puffs will be recorded.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 8, 2021)
  • Puff volume [ Time Frame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout. ]
    The volume of each puff, in ml.
  • Puff duration [ Time Frame: Puff duration will be measured during the approximately 5-minute, 10-puff use bout. ]
    The duration of each puff, measured in second.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 4, 2020)
  • Change in heart rate [ Time Frame: Baseline to 255 minutes ]
    Change in heart rate, measured in beats per minute.
  • Puff volume [ Time Frame: Puff volume will be measured during the approximately 5-minute, 10-puff use bout. ]
    The volume of each puff, in ml.
  • Puff duration [ Time Frame: Puff duration will be measured during the approximately 5-minute, 10-puff use bout. ]
    The duration of each puff, measured in second.
  • Inter puff interval [ Time Frame: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout. ]
    The time between each puff, in seconds.
  • Flow rate [ Time Frame: Flow rate will be measured during the approximately 5-minute, 10-puff use bout. ]
    The rate of air flow during each puff, in ml/second.
  • Direct Effects of Vaping Questionnaire [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to the effects of vaping (10 questions, each scored from 0 - 100).
  • Direct Effects of Nicotine Questionnaire [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to the side effects of nicotine (10 questions, each scored from 0 - 100).
  • Hughes-Hatsukami Questionnaire [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to nicotine abstinence symptoms (11 questions, each scored from 0 - 100).
  • General Labeled Magnitude Scale [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to perceptions of electronic cigarette effects (3 questions, each scored from 0 - 100).
  • Labeled Hedonic Scale [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100).
Current Other Pre-specified Outcome Measures
 (submitted: February 8, 2021)
  • Change in heart rate [ Time Frame: Baseline to 255 minutes ]
    Change in heart rate, measured in beats per minute.
  • Inter puff interval [ Time Frame: Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout. ]
    The time between each puff, in seconds.
  • Flow rate [ Time Frame: Flow rate will be measured during the approximately 5-minute, 10-puff use bout. ]
    The rate of air flow during each puff, in ml/second.
  • Direct Effects of Vaping Questionnaire [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to the effects of vaping (10 questions, each scored from 0 - 100).
  • Direct Effects of Nicotine Questionnaire [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to the side effects of nicotine (10 questions, each scored from 0 - 100).
  • Hughes-Hatsukami Questionnaire [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to nicotine abstinence symptoms (11 questions, each scored from 0 - 100).
  • General Labeled Magnitude Scale [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to perceptions of electronic cigarette effects (3 questions, each scored from 0 - 100).
  • Labeled Hedonic Scale [ Time Frame: This measure will be administered at approximately 90, 100, 120, 190, and 205 minutes. ]
    This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100).
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assessing Electronic Cigarette Nicotine Flux
Official Title  ICMJE Assessing Electronic Cigarette Nicotine Flux
Brief Summary The purpose of this study is to determine differences in nicotine delivery, use behavior, carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
The purpose of this study is to determine differences in nicotine delivery, use behavior, (puff topography), and carbon monoxide delivery, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with constant device settings and different e-liquid concentrations.
Masking: Single (Participant)
Masking Description:
Participants will be blinded to the power level and nicotine concentration used in each session.
Primary Purpose: Basic Science
Condition  ICMJE Electronic Cigarette Use
Intervention  ICMJE Other: ECIG Lab Session, 30 watts
During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
Study Arms  ICMJE
  • Active Comparator: Cigarette Smokers: 0 mg/ml nicotine concentration

    ECIG Lab Session, 30 watts, 0 mg/ml nicotine concentration

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

    Intervention: Other: ECIG Lab Session, 30 watts
  • Experimental: Cigarette Smokers: 4 mg/ml nicotine concentration

    ECIG Lab Session, 30 watts, 6 mg/ml nicotine concentration

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

    Intervention: Other: ECIG Lab Session, 30 watts
  • Experimental: Cigarette Smokers: 15 mg/ml nicotine concentration

    ECIG Lab Session, 30 watts, 15 mg/ml nicotine concentration

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

    Intervention: Other: ECIG Lab Session, 30 watts
  • Experimental: Cigarette Smokers: 30 mg/ml nicotine concentration

    ECIG Lab Session, 30 watts, 30 mg/ml nicotine concentration

    During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.

    Intervention: Other: ECIG Lab Session, 30 watts
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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 4, 2020)
32
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy (determined by self-report)
  • between the ages of 18-55
  • willing to provide informed consent
  • able to attend the lab and abstain from tobacco/nicotine as required and must agree to use designated products according to study protocol

Exclusion Criteria:

• Women if they are breast-feeding or test positive for pregnancy (by urinalysis) at screening.

Some study details about the eligibility criteria are purposely omitted at this time to preserve scientific integrity. Full details will be posted at the conclusion of the study.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Alison Breland, PhD (804) 628-2300 abbrelan@vcu.edu
Contact: Thomas Eissenberg, PhD 804-827-3562 teissenb@vcu.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04378907
Other Study ID Numbers  ICMJE HM20018580
Has Data Monitoring Committee Not Provided
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: Undecided
Responsible Party Virginia Commonwealth University
Study Sponsor  ICMJE Virginia Commonwealth University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Alison Breland, PhD Virginia Commonwealth University
PRS Account Virginia Commonwealth University
Verification Date February 2021

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