Assessment of Two New Electronic Cigarettes in Cigarette Smokers

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 16, 2019

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).
  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Virginia Commonwealth University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Alison Breland, PhD, Principal Investigator, Virginia Commonwealth University

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.