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Completed

NCT Number: NCT03435562

Assessment of Two New Electronic Cigarettes in Cigarette Smokers

The purpose of this study is to determine differences in nicotine delivery, user behavior, subjective effects, and physiological effects, when cigarette smokers use an two new electronic cigarette devices (JUUL and IQOS) relative to their using their own brand of cigarettes.

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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 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
  • cigarette smokers

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

JUUL electronic cigarette

Other

Effects of JUUL electronic cigarette use.

IQOS electronic cigarette

Other

Effects of IQOS electronic cigarette use.

Own Brand Cigarette

Other

Effects of own brand cigarette use.

Primary outcomes

  1. Change in Plasma Nicotine

    Time frame: Blood will be taken 4 times in each session: at baseline, 5 min after the start of a 10-puff product use, and then before and after an approximately 1-hour ad lib use period.

    Change in plasma nicotine level

Secondary outcomes

  1. 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.

    Carbon monoxide levels (in parts per mission)

  2. Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1

    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 the intention to smoke a cigarette, and consists of 5 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 30 with higher scores indicating higher craving for a cigarette.

  3. Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2

    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 the intention to smoke a cigarette, and consists of 4 items that are scored 0 - 7, in which participants clicked seven discrete ratings from 'not at all' to 'extremely'. The items are summed and scores range from 0 to 24 with higher scores indicating higher craving for a cigarette.

  4. Hughes-Hatsukami Questionnaire - Anxious

    Time frame: Questionnaire will be administered 4 times in 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 affects on anxiety and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  5. Hughes-Hatsukami Questionnaire - Craving

    Time frame: Questionnaire will be administered 4 times in 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 affects on craving a cigarette and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  6. Hughes-Hatsukami Questionnaire - Depression

    Time frame: Questionnaire will be administered 4 times in 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 affects on depression and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  7. Hughes-Hatsukami Questionnaire - Difficulty Concentrating

    Time frame: Questionnaire will be administered 4 times in 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 affects having difficulty concentrating and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  8. Hughes-Hatsukami Questionnaire - Drowsy

    Time frame: Questionnaire will be administered 4 times in 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 affects feeling drowsy and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  9. Hughes-Hatsukami Questionnaire - Hunger

    Time frame: Questionnaire will be administered 4 times in 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 affects reducing hunger and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  10. Hughes-Hatsukami Questionnaire - Impatient

    Time frame: Questionnaire will be administered 4 times in 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 affects feeling impatient and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  11. Hughes-Hatsukami Questionnaire - Irritable

    Time frame: Questionnaire will be administered 4 times in 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 affects feeling irritable and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  12. Hughes-Hatsukami Questionnaire - Restless

    Time frame: Questionnaire will be administered 4 times in 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 affects feeling restless and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  13. Hughes-Hatsukami Questionnaire - Desire for Sweets

    Time frame: Questionnaire will be administered 4 times in 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 affects having desire for sweets and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  14. Hughes-Hatsukami Questionnaire - Urge to Smoke

    Time frame: Questionnaire will be administered 4 times in 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 affects having the urge to smoke and consists of 1 item scored 0 - 100 with 0 being not at all and 100 being extremely.

  15. Direct Effects of Nicotine Questionnaire - Awake

    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.

    One question is used to assess how much product use makes participants feel awake, and is scored 0 (not at all) to 100 (extremely).

  16. Direct Effects of Nicotine Questionnaire - Calm

    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.

    One question is used to assess how much product use makes participants feel calm, and is scored 0 (not at all) to 100 (extremely).

  17. Direct Effects of Nicotine Questionnaire - Concentrate

    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.

    One question is used to assess how much product use helps participants concentrate, and is scored 0 (not at all) to 100 (extremely).

  18. Direct Effects of Nicotine Questionnaire - Dizzy

    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.

    One question is used to assess how much product use makes participants feel dizzy, and is scored 0 (not at all) to 100 (extremely).

  19. Direct Effects of Nicotine Questionnaire - Reduce Hunger

    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.

    One question is used to assess how much product use reduces feeling of hunger, and is scored 0 (not at all) to 100 (extremely).

  20. Direct Effects of Nicotine Questionnaire - Sick

    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.

    One question is used to assess how much product use makes participants feel sick, and is scored 0 (not at all) to 100 (extremely).

  21. Direct Effects of Product Use Questionnaire - Pleasant

    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 approxiamtely 1-hour ad lib use period.

    A single question is used to assess if product use felt pleasant, and is scored 0 (not at all) to 100 (extremely).

  22. Direct Effects of Product Use Questionnaire - Taste Good

    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 approxiamtely 1-hour ad lib use period.

    A single question is used to assess if product use tasted good, and is scored 0 (not at all) to 100 (extremely).

  23. Direct Effects of Product Use Questionnaire - Satisfying

    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 approxiamtely 1-hour ad lib use period.

    A single question is used to assess if product use felt satisfying, and is scored 0 (not at all) to 100 (extremely).

  24. Direct Effects of Product Use Questionnaire - Smoke Right Now

    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 approxiamtely 1-hour ad lib use period.

    A single question is used to assess if product use made them want to use the product again right now, and is scored 0 (not at all) to 100 (extremely).

Other outcomes

  1. Heart Rate

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

    Change in heart rate, measured in beats per minute

  2. 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

Sponsors and collaborators

Lead sponsor

Virginia Commonwealth University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2018
Registry last updated
Aug 3, 2020

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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