N/A
N=22
The Effect of Electronic Cigarette Liquid Characteristics in Smokers.
Electronic Cigarettes
Bottom Line
View on ClinicalTrials.gov: NCT03861078 ↗Enrolled (actual)
22
Serious AEs
—
Results posted
Dec 2022
Primary outcome: Primary: Plasma Nicotine Concentration — 12.32; -0.22; 7.09; 5.85 ng/ml
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 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 (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Dec 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Nicotine Concentration |
12.32; -0.22; 7.09; 5.85; -0.29 | — |
| PRIMARY Progressive Ratio Task - Breakpoint |
416.07; 307.29; 336.43; 492.86; 812.86 | — |
| PRIMARY Progressive Ratio Task - Number of Puffs |
7.64; 6.21; 5.07; 7.21; 9.93 | — |
| PRIMARY Progressive Ratio Task - Latency |
161176.93; 390300.43; 315803.79; 263130.86; 6500.64 | — |
| SECONDARY Puff Volume |
207.17; 233.47; 130.57; 166.51; 65.12 | — |
| SECONDARY Puff Duration |
2.54; 2.74; 1.60; 1.94; 2.06 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03861078). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.