The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
3 other identifiers
interventional
22
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
March 4, 2019
CompletedStudy Start
First participant enrolled
February 17, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2021
CompletedResults Posted
Study results publicly available
December 23, 2022
CompletedDecember 23, 2022
November 1, 2022
1.8 years
January 14, 2019
October 10, 2022
November 30, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (2)
Puff Volume
Puff volume will be measured during the approximately 5-minute, 10-puff use bout.
Puff Duration
The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.
Other Outcomes (6)
Hughes-Hatsukami Questionnaire
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 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 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)
- +3 more other outcomes
Study Arms (1)
Cigarette smokers
EXPERIMENTALEach 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
Interventions
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, 23298, United States
Related Publications (1)
Maloney SF, Hoetger C, Bono RS, Lester Scholtes R, Combs M, Karaoghlanian N, Lipato T, Breland A, Eissenberg T. Assessment of human abuse potential of an unflavored, sucralose-sweetened electronic cigarette in combustible cigarette smokers. Exp Clin Psychopharmacol. 2024 Oct;32(5):588-603. doi: 10.1037/pha0000720. Epub 2024 May 30.
PMID: 38815111DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alison Breland
- Organization
- Virginia Commonwealth University
Study Officials
- STUDY DIRECTOR
Alison Breland, PhD
Virginia Commonwealth University
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2019
First Posted
March 4, 2019
Study Start
February 17, 2020
Primary Completion
December 13, 2021
Study Completion
December 13, 2021
Last Updated
December 23, 2022
Results First Posted
December 23, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share