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Completed

NCT Number: NCT03861078

The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

The purpose of this study is to determine differences in nicotine delivery, user behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.

Completed

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Key information

Conditions

Electronic Cigarettes Behavior Smoking Vaping

Age range

21 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinical Behavioral Pharmacology 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 21-55 years old
  • Current cigarette smokers
  • Wiling to provide informed consent
  • Able to attend the lab session and abstain from tobacco/nicotine products as required
  • Agree to use designated products according to the 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

Own Brand Cigarette

Other

Effects of own brand cigarette use.

ECIG 15 mg nicotine, sweetened

Other

Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid

ECIG 15 mg nicotine, unsweet

Other

Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid

ECIG 0 mg nicotine, sweetened

Other

Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid

ECIG 0 mg nicotine, unsweet

Other

Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid

Primary outcomes

  1. Plasma Nicotine Concentration

    Time frame: Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).

    Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.

  2. Progressive Ratio Task - Breakpoint

    Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.

    The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here.

  3. Progressive Ratio Task - Number of Puffs

    Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.

    The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here.

  4. Progressive Ratio Task - Latency

    Time frame: This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.

    The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here.

Secondary outcomes

  1. 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, averaged over the 10-puff use bout

  2. Puff Duration

    Time frame: The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.

    The duration of each puff, in seconds, averaged over the 10-puff use bout

Other outcomes

  1. Hughes-Hatsukami Questionnaire

    Time frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)

    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.

  2. Positive and Negative Affect Schedule

    Time frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)

    This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from "very slightly or not at all" to "extremely". The items from this scale are scored into two dimensions: Positive Affect and Negative Affect.

  3. Drug Effects Questionnaire

    Time frame: This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)

    This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales).

  4. Heart Rate

    Time frame: Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes)

    Change in heart rate, measure in beats per minute.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 4, 2019
Registry last updated
Dec 23, 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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