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Assessment of Two New Electronic Cigarettes in Cigarette Smokers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03435562
Recruitment Status : Completed
First Posted : February 19, 2018
Results First Posted : August 3, 2020
Last Update Posted : August 3, 2020
Sponsor:
Information provided by (Responsible Party):
Virginia Commonwealth University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Electronic Cigarettes Other: JUUL electronic cigarette Other: IQOS electronic cigarette Other: Own Brand cigarette Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Assessment of Two New Electronic Cigarettes in Cigarette Smokers
Actual Study Start Date : March 3, 2018
Actual Primary Completion Date : August 16, 2019
Actual Study Completion Date : August 16, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes

Arm Intervention/treatment
Experimental: electronic cigarette vs own brand use
Participants will come in for three session. During one session, participants will first complete a 10-puff product use bout with JUUL, and then a 90-minute ad lib product use bout with JUUL (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with IQOS, and then a 90-minute ad lib product use bout with IQOS (the session will be approximately 3 hours). During one session, participants will first complete a 10-puff product use bout with their own brand cigarettes, and then a 90-minute ad lib product use bout with their own brand cigarette (the session will be approximately 3 hours). The order of the sessions will be determined randomly and data about session will not be recorded or used in the analysis.
Other: JUUL electronic cigarette
Effects of JUUL electronic cigarette use.

Other: IQOS electronic cigarette
Effects of IQOS electronic cigarette use.

Other: Own Brand cigarette
Effects of own brand cigarette use.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03435562


Locations
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United States, Virginia
Clinical Behavioral Pharmacolgy Laboratory
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
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Principal Investigator: Alison Breland, PhD Virginia Commonwealth University
  Study Documents (Full-Text)

Documents provided by Virginia Commonwealth University:
Informed Consent Form  [PDF] July 12, 2019
Study Protocol  [PDF] April 11, 2019
No Statistical Analysis Plan (SAP) exists for this study.

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Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT03435562    
Other Study ID Numbers: HM20012013
First Posted: February 19, 2018    Key Record Dates
Results First Posted: August 3, 2020
Last Update Posted: August 3, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No