The Effect of Electronic Cigarette Liquid Characteristics in Smokers.

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.

Study Overview

• Status: Completed
• Conditions: Electronic Cigarettes
• Intervention / Treatment: Other: Own Brand Cigarette; Other: ECIG 15 mg nicotine, sweetened; Other: ECIG 15 mg nicotine, unsweet; Other: ECIG 0 mg nicotine, sweetened; Other: ECIG 0 mg nicotine, unsweet

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cigarette smokers; Each participant will participate in 5 sessions. During each session, participants will complete a 10-puff, directed product use bout, and then have the option later to puff as little or as much as they like during a 30-minute self administration task. Session 1: Own brand cigarette use Session 2: ECIG 15 mg nicotine, sweetened Session 3: ECIG Lab Session ECIG 15 mg nicotine, unsweetened Session 4: ECIG Lab Session ECIG 0 mg nicotine, sweetened Session 5: ECIG Lab Session ECIG 0 mg nicotine, unsweetened

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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.
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.
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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.
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.

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Collaborators: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2020
• Primary Completion (Actual): December 13, 2021
• Study Completion (Actual): December 13, 2021

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 4, 2019

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: November 30, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: HM20015258; U54DA036105 (U.S. NIH Grant/Contract); F31DA047018 (U.S. NIH Grant/Contract)

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