The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

Electronic Cigarettes Clinical Trial

Official title:

The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03861078
• Other study ID #: HM20015258
• Secondary ID: U54DA036105F31DA
• Status: Completed
• Phase: N/A
• Start date: February 17, 2020
• Est. completion date: December 13, 2021

Study information

• Verified date: November 2022
• 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 behaviors, subjective effects, and physiological effects, when cigarette smokers use an electronic cigarette with different nicotine (and sweetener) concentrations relative to using their own brand of cigarettes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: December 13, 2021
• Est. primary completion date: December 13, 2021
• 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 21-55 years old

• Current cigarette smokers

• Wiling to provide informed consent

• Able to attend the lab session and abstain from tobacco/nicotine products as required

• Agree to use designated products according to the study protocol

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:
• Own Brand Cigarette
Effects of own brand cigarette use.
• ECIG 15 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
• ECIG 15 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
• ECIG 0 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
• ECIG 0 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Virginia Commonwealth University	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hughes-Hatsukami Questionnaire	This scale will be used to assess the extent to which product use reduces tobacco abstinence symptoms, and consists of 11 items scored 0-100, with lower scores indicating less severe symptoms. There are no sub-scales. Items are analyzed separately.	This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
Other	Positive and Negative Affect Schedule	This scale will be used to measure positive and negative affect and consists of 20-items that are scored on a 5-point likert scale ranging from "very slightly or not at all" to "extremely". The items from this scale are scored into two dimensions: Positive Affect and Negative Affect.	This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
Other	Drug Effects Questionnaire	This questionnaire assess a respondent's feelings after recently using tobacco or nicotine products. It has a total of five items that participants rate from not at all to extremely scored 0-100. Each item is scored and analyzed separately (there are no sub-scales).	This questionnaire will be administered 4 times in each session to examine changes from baseline (70 minutes) to immediately following a ten-puff bout (80 minutes), and immediately before (140 minutes) and after the PRT (180 minutes)
Other	Heart Rate	Change in heart rate, measure in beats per minute.	Heart rate will be measured continuously throughout the session, and will be used to examine changes in HR from baseline (70 minutes) to during (75 minutes) and immediately following a ten-puff bout (80 minutes)
Other	Inter Puff Interval	The time between each puff, in seconds.	Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.
Other	Flow Rate	The rate of air flow during each puff, in ml/second.	Flow rate will be measured during the approximately 5-minute, 10-puff use bout.
Primary	Plasma Nicotine Concentration	Change in plasma nicotine concentration. Changes in plasm nicotine concentration during puff bout are considered to be the more relevant and accurate values so analysis and results reporting will focus on change from baseline to immediately following 10-puff bout.	Blood will be taken 4 times in each session to examine changes from baseline (approx 70 minutes) to immediately following a ten-puff bout (approx 80 minutes), and immediately before (approx 140 minutes) and after the PRT (approx 180 minutes).
Primary	Progressive Ratio Task - Breakpoint	The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Breakpoint is reported here.	This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Primary	Progressive Ratio Task - Number of Puffs	The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (sec) to initiate key pressing. Number of puffs is reported here.	This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Primary	Progressive Ratio Task - Latency	The progressive ratio task (PRT) is a self-administration task that will take 30-minutes to complete. It will begin by requiring ten computer key presses to earn the first puff of the session product, and this requirement will increase by 30% (i.e., 10, 13, 17, etc.) after each reinforcer (puff) is earned and consumed. The PRT will have three outcome measures (1) breakpoint (maximum number of key presses completed to earn a puff), (2) number of puffs, and (3) latency (milliseconds) to initiate key pressing. Latency is reported here.	This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.
Secondary	Puff Volume	The volume of each puff, in ml, averaged over the 10-puff use bout	Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
Secondary	Puff Duration	The duration of each puff, in seconds, averaged over the 10-puff use bout	The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.