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OpenTrials
Completed

NCT Number: NCT03710590

Effects of Electronic Cigarette Settings and Liquid Concentrations in Cigarette Smokers and Electronic Cigarette Users

The purpose of this research study is to find out how different types of electronic cigarettes (ECIG) settings, combined with e-liquids of differing nicotine concentrations, affect blood nicotine levels, use behavior (how users puff), and how users feel.

Completed

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Key information

Conditions

Electronic Cigarettes Behavior Smoking Vaping

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Behavioral Pharmacolgy Laboratory

Richmond, Virginia, 23298, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

--participants must be:

  • 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.
  • Individuals who weigh less than 110 pounds

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

ECIG Lab Session 15 watts, 10 mg nicotine

Other

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

ECIG Lab Session 15 watts, 15 mg nicotine

Other

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

ECIG Lab Session 15 watts, 30 mg nicotine

Other

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

ECIG Lab Session 30 watts, 10 mg nicotine

Other

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

ECIG Lab Session 30 watts, 15 mg nicotine

Other

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

ECIG Lab Session 30 watts, 30 mg nicotine

Other

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

Primary outcomes

  1. Change in Plasma Nicotine

    Time frame: Baseline to 5 min after the start of a 10-puff product use

    Change in plasma nicotine level.

  2. Puff Volume

    Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes

    The average volume of each puff, in ml, during 10 puff bout.

  3. Puff Duration

    Time frame: Each time the e-cigarette is used during the 10-puff use bout - 5 minutes

    The average duration of each puff, in seconds.

Secondary outcomes

  1. Heart Rate

    Time frame: Heart rate will be measured from baseline continuously throughout the 10-puff bout - 5 minutes

    Average heart rate, measured in beats per minute.

Other outcomes

  1. Inter Puff Interval

    Time frame: Inter puff interval will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

    The time between each puff, in seconds

  2. Flow Rate

    Time frame: Flow rate will be measured each time the e-cigarette is used during an approximately 4 hour session: during a 5-minute 10-puff use bout, and during an approximately 90 minute ad lib use period

    The rate of air flow during each puff, in ml/second

  3. Hughes-Hatsukami Questionnaire

    Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

    This scale is 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.

  4. Direct Effects of Product Use Questionnaire

    Time frame: Questionnaire will be administered 2 times in each each approximately 4-hr session: 10 minutes after the start of a 10-puff use bout, and then after an approximately 1-hour ad lib use period.

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

  5. Direct Effects of Nicotine Questionnaire

    Time frame: Questionnaire will be administered 4 times in each each approximately 4-hr session: before any product use, 10 minutes after the start of a 10-puff use bout, and then before and after an approximately 1-hour ad lib use period.

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

  6. Carbon Monoxide Levels

    Time frame: Carbon monoxide levels will be assessed before and after product use in each approximately 4-hr session: at baseline, 5 min after the end of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

    Change in carbon monoxide levels (in parts per mission)

  7. Blood Pressure

    Time frame: Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session

    Change in blood pressure, measured in mm/hg

  8. General Labeled Magnitude Scale

    Time frame: The General Labeled Magnitude Scale will be administered twice in each approximately 4 hour session--after a 5-minute 10 puff use bout, and after the approximately 90 minute ad lib period.

    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 if scored nd analyzed separately (there are no sub-scales).

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 18, 2018
Registry last updated
Oct 6, 2022

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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