N/A
Completed N=88
Evaluating E-Cigarette Nicotine Form, Concentration, and Flavors Among Youth
Source: ClinicalTrials.gov NCT05458895 ↗Enrolled (actual)
88
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcomePrimary: Plasma Nicotine Concentration — 0.78; 1.08; 0.89; 1.16 ng/ml
Summary
This clinical trial examines the influence of nicotine form, concentration, and e-liquid flavor on youth vaping behavior, as well as the heart and lung effects associated with this behavior. Electronic cigarette (e-cig) "vaping", while being promoted as a safer alternative to conventional cigarettes, has disproportionately attracted adolescents and young adults ("youth"). This trial may help researchers understand how nicotine form, concentration, and flavor affects people's vaping behaviors and health.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plasma Nicotine Concentration |
0.78; 1.08; 0.89; 1.16; 0.80; 0.88 | — |
| PRIMARY Puff Count |
16.17; 16.67; 17.67; 17.88; 12.52; 11.29 | — |
| PRIMARY Average Puff Duration |
3.20; 3.04; 3.16; 3.15; 2.65; 2.57 | — |
| PRIMARY Average Puff Volume |
48.68; 46.31; 50.64; 51.92; 36.82; 35.12 | — |
| PRIMARY Lung Function Assessment |
-0.03; -0.05; -0.01; 0.003; -0.08; -0.02 | — |
| PRIMARY Airway Inflammation (NIOX VERO) |
18.94; 19.27; 18.95; 19.69; 18.52; 21.94 | — |
| SECONDARY Sensory E-Cigarette Expectancies Scale (SEES) |
2.69; 2.76; 1.66 | — |
| SECONDARY Modified Cigarette Dependence Scale |
17.37 | — |
| SECONDARY Drug Effects/Liking Questionnaire |
40.40; 32.59; 44.69; 37.78; 27.48; 17.16 | — |
| SECONDARY Modified Cigarette Evaluation Questionnaire (mCEQ) |
3.35; 2.78; 3.58; 2.97; 2.93; 2.26 | — |
| SECONDARY E-cigarette Purchase Task - Breakpoint |
0.5; 0.38; 1; 0.5; 0.5; 0.25 | — |
| SECONDARY Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form |
24.85; 25.44; 25.51; 25.56; 24.52; 25.25 | — |
| SECONDARY Vascular Reactivity |
0.47 | — |
Eligibility Criteria
Inclusion Criteria
- A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 3 months (confirmed in lab by salivary cotinine)
- 21-25 years old
- Willing to abstain from all tobacco and nicotine for at least 12 hours prior to lab sessions
- Willing to complete five, 6 hour lab visits
- Able to read and speak English
- Willing to provide informed consent
Exclusion Criteria
- Self-reported diagnosis of lung disease including asthma, cystic fibrosis, or chronic obstructive pulmonary disease
- Unstable or significant psychiatric conditions (past and stable conditions will be allowed)
- History of cardiac event or distress within the past 3 months
- Currently pregnant (determined using urine pregnancy test), planning to become pregnant, or breastfeeding
- Use of other tobacco products > 5 days in the past month
- Current marijuana use > 5 times per month
- Currently engaging in a vaping cessation attempt
- Ohio State University (OSU) verifies study project 2 current membership/past participation
Data sourced from ClinicalTrials.gov (NCT05458895). 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. Informational only — not medical advice.