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Completed

NCT Number: NCT05587504

Determination of Liquid Flavor and Nicotine Form Outcomes

The purpose of this research study is to find out how different types of electronic cigarette/vape e-liquids with differing sweetness and forms of nicotine affect blood nicotine levels, use behavior (how people puff), and how people feel.

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Key information

Conditions

Electronic Cigarettes Behavior Smoking Vaping

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

About this study

In this study, participants will be asked to do the following:

  • After an initial screening visit, visit the Center for the Study of Tobacco Products 4 more times for approximately 3-hour study visits.
  • Before each visit, abstain from all tobacco products (cigarettes, e-cigarettes/vapes, cigars, and hookah/waterpipe) for at least 12 hours.
  • Allow researcher to take blood pressure readings (with blood pressure cuff on their arm) monitor their heart rate (with a device that attaches to their finger), and allow a nurse to insert an IV catheter into their arm that will stay there for the entire session. This catheter will be used to draw blood periodically (less than 1 tablespoon per sample, 5 samples per visit).
  • During each session, participants will respond to several questionnaires to measure how they feel before and after they use an e-cigarette.
  • In each session, use an electronic cigarette provided by the study team at two separate times. After using the e-cigarette two times, participants will be offered the opportunity to use their own e-cigarette or cigarette.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy (determined by self-report)
  • between the ages of 18-65
  • willing to provide informed consent
  • use cigarettes, e-cigarettes, or both
  • 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
  • existence of any condition contraindicated for this study protocol as determined by study leadership

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.

Treatment and study plan

E-cigarette with sweetness type 1 and pronation level 1

Other

An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 1.

E-cigarette with sweetness type 1 and pronation level 2

Other

An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 1 and protonation level 2.

E-cigarette with sweetness type 2 and pronation level 1

Other

An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 1.

E-cigarette with sweetness type 2 and pronation level 2

Other

An "open system" ECIG (Kanger Sub Box Mini and/or a Kangertech Sub Box Mini tank connected to hardware and/or software to limit puff duration) set to 15 Watts, which will contain e-liquid that contains a predetermined mg/ml of nicotine and sweetness type 2 and protonation level 2.

Primary outcomes

  1. Change in plasma nicotine concentration

    Time frame: Baseline (approx 90 min after session start) to after final product usage (up to 165 min)

    Blood will be taken multiple times in each session to examine changes in plasma nicotine concentration from baseline to after various e-cigarette or cigarette usage.

  2. Puff volume

    Time frame: Through the final product use (up to 165 min)

    The volume of each puff, in ml, averaged over each product use bout.

  3. Puff duration

    Time frame: Through the final product use (up to 165 min)

    The duration of each puff, in ml, averaged over each product use bout.

  4. Challenge paradigm latency

    Time frame: at the end of the challenge paradigm, approx. 165 min

    The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the time it takes for the participant to pick up the product.

  5. Challenge paradigm puffs

    Time frame: at the end of the challenge paradigm, approx. 165 min

    The cigarette or own brand e-cigarette challenge paradigm involves giving participants a five minute period to use their own brand cigarette or e-cigarette. Researchers measure the number of puffs the participant takes.

Other outcomes

  1. Change in Direct Effects of Product use Questionnaires

    Time frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

    Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage.

    This scale is used to assess how product use makes participants feel and consists of 10 questions each for e-cigarettes and cigarettes that are scored 0 - 100. There are no sub-scales. Items are analyzed separately.

  2. Change in Hughes-Hatsukami Questionnaire

    Time frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

    Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage.

    This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.

  3. Change in General Labeled Magnitude Scale

    Time frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

    Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage.

    This scale measures the flavor sensation, harshness, and throat hit (in three questions that correspond to those constructs) of the e-cigarette used in each session. The scale ranges from 0 - 100, with 0 being no sensation and 100 being the strongest imaginable sensation of any kind. Each item is scored and analyzed separately (there are no sub-scales).

  4. Change in Labeled Hedonic Scale

    Time frame: Baseline (approx 90 min after session start) to after final product usage (up to 185 min)

    Surveys will be completed multiple times in each session to examine changes from baseline to after specific e-cigarette or cigarette usage.

    This measure is related to perceptions of electronic cigarette effects (4 questions, each scored from 0 - 100).

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 20, 2022
Registry last updated
Feb 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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