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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarettes
• Intervention / Treatment: Other: JUUL electronic cigarette; Other: IQOS electronic cigarette; Other: Own Brand cigarette

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Clinical Behavioral Pharmacolgy Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Plasma Nicotine	Change in plasma nicotine level	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Carbon Monoxide Levels	Carbon monoxide levels (in parts per mission)	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.
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 1	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.	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.
Tiffany-Drobes Questionnaire of Smoking Urges - Factor 2	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.	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.
Hughes-Hatsukami Questionnaire - Anxious	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.	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.
Hughes-Hatsukami Questionnaire - Craving	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.	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.
Hughes-Hatsukami Questionnaire - Depression	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.	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.
Hughes-Hatsukami Questionnaire - Difficulty Concentrating	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.	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.
Hughes-Hatsukami Questionnaire - Drowsy	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.	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.
Hughes-Hatsukami Questionnaire - Hunger	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.	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.
Hughes-Hatsukami Questionnaire - Impatient	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.	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.
Hughes-Hatsukami Questionnaire - Irritable	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.	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.
Hughes-Hatsukami Questionnaire - Restless	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.	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.
Hughes-Hatsukami Questionnaire - Desire for Sweets	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.	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.
Hughes-Hatsukami Questionnaire - Urge to Smoke	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.	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.
Direct Effects of Nicotine Questionnaire - Awake	One question is used to assess how much product use makes participants feel awake, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Nicotine Questionnaire - Calm	One question is used to assess how much product use makes participants feel calm, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Nicotine Questionnaire - Concentrate	One question is used to assess how much product use helps participants concentrate, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Nicotine Questionnaire - Dizzy	One question is used to assess how much product use makes participants feel dizzy, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Nicotine Questionnaire - Reduce Hunger	One question is used to assess how much product use reduces feeling of hunger, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Nicotine Questionnaire - Sick	One question is used to assess how much product use makes participants feel sick, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Product Use Questionnaire - Pleasant	A single question is used to assess if product use felt pleasant, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Product Use Questionnaire - Taste Good	A single question is used to assess if product use tasted good, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Product Use Questionnaire - Satisfying	A single question is used to assess if product use felt satisfying, and is scored 0 (not at all) to 100 (extremely).	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.
Direct Effects of Product Use Questionnaire - Smoke Right Now	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).	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Pressure	Change in blood pressure, measured in mm/hg	Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
Heart Rate	Change in heart rate, measured in beats per minute	Heat rate will be measured from baseline continuously throughout each each approximately 4-hr session

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): August 16, 2019
• Study Completion (Actual): August 16, 2019

Study Registration Dates

• First Submitted: February 1, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 19, 2018

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 16, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: HM20012013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No