The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Own brand cigarette use 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. |
Other: Own Brand Cigarette
Effects of own brand cigarette use.
|
| Experimental: ECIG 15 mg nicotine, sweetened During each session, participants will complete a 10-puff 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. |
Other: ECIG 15 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
|
| Experimental: ECIG 15 mg nicotine, unsweetened During each session, participants will complete a 10-puff 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. |
Other: ECIG 15 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
|
| Experimental: ECIG 0 mg nicotine, sweetened During each session, participants will complete a 10-puff 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. |
Other: ECIG 0 mg nicotine, sweetened
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
|
| Experimental: ECIG 0 mg nicotine, unsweetened During each session, participants will complete a 10-puff 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. |
Other: ECIG 0 mg nicotine, unsweet
Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
|
Outcome Measures
Primary Outcome Measures
- Plasma Nicotine Concentration [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).]
Change in plasma nicotine concentration.
- Progressive Ratio Task [This task will begin approximately an hour and ten minutes after the 10-puff directed product use bout.]
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.
Secondary Outcome Measures
- Puff volume [Puff volume will be measured during the approximately 5-minute, 10-puff use bout.]
The volume of each puff, in ml.
- Puff Duration [The duration of each puff will be measured during the approximately 5-minute, 10-puff use bout.]
The duration of each puff, in seconds.
Other Outcome Measures
- 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)]
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.
- 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)]
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.
- 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)]
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).
- Heart rate [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)]
Change in heart rate, measure in beats per minute.
- Inter puff interval [Inter puff interval will be measured during the approximately 5-minute, 10-puff use bout.]
The time between each puff, in seconds.
- Flow rate [Flow rate will be measured during the approximately 5-minute, 10-puff use bout.]
The rate of air flow during each puff, in ml/second.
Eligibility Criteria
Criteria
Inclusion Criteria-- Participants must be:
-
Healthy (determined by self-report)
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Between the ages of 21-55 years old
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Current cigarette smokers
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Wiling to provide informed consent
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Able to attend the lab session and abstain from tobacco/nicotine products as required
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Agree to use designated products according to the study protocol
Exclusion Criteria:
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Clinical Behavioral Pharmacology Laboratory | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
- National Institute on Drug Abuse (NIDA)
Investigators
- Study Director: Alison Breland, PhD, Virginia Commonwealth University
Study Documents (Full-Text)
More Information
Publications
None provided.- HM20015258
- U54DA036105
- F31DA047018