Assessment of Two New Electronic Cigarettes in Cigarette Smokers

Electronic Cigarettes Clinical Trial

Official title:

Assessment of Two New Electronic Cigarettes in Cigarette Smokers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03435562
• Other study ID #: HM20012013
• Status: Completed
• Phase: N/A
• Start date: March 3, 2018
• Est. completion date: August 16, 2019

Study information

• Verified date: July 2020
• Source: Virginia Commonwealth University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: August 16, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electronic Cigarettes

Intervention

Other:
• JUUL electronic cigarette
Effects of JUUL electronic cigarette use.
• IQOS electronic cigarette
Effects of IQOS electronic cigarette use.
• Own Brand cigarette
Effects of own brand cigarette use.

Locations

Country	Name	City	State
United States	Clinical Behavioral Pharmacolgy Laboratory	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Blood Pressure	Change in blood pressure, measured in mm/hg	Blood pressure will be measured from baseline continuously throughout each approximately 4-hr session
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.