N/A
N=20
Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
Cigarette Smoking-Related Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT05455086 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: PET/CT Imaging of the Head — 2.81; 2.40 %TAD/kg
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Cigarette Smoking (Behavioral); Computed Tomography (Procedure); Positron Emission Tomography (Procedure); Questionnaire Administration (Other)
- Age
- Adult · 21+ yrs
- Sex
- All
- Sponsor
- Ohio State University Comprehensive Cancer Center
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PET/CT Imaging of the Head |
2.81; 2.40 | — |
| PRIMARY PET/CT Imaging of the Chest |
6.18; 11.62; 10.35; 5.53 | — |
| PRIMARY Puff Volume (mL) |
79.35; 73.76 | — |
| PRIMARY Puff Duration (s) |
2.87; 2.82 | — |
| PRIMARY Age of First Tobacco Use |
14.58; 14.63 | — |
| PRIMARY Years of Tobacco Use |
19.58; 16.88 | — |
| PRIMARY Years of Regular Use of Nicotine/Tobacco Products |
16.83; 15.13 | — |
| PRIMARY Past 30 Day Use of Nicotine/Tobacco Products |
0; 0.75; 0; 0; 0; 0 | — |
| PRIMARY Modified Cigarette Evaluation Questionnaire (mCEQ) |
2.28; 1.42; 2.17; 1.38; 0.88; 0.94 | — |
| PRIMARY Drug Effects Liking Questionnaire (DEQ) |
60.08; 42.88; 51.25; 32.50; 57.25; 31.88 | — |
| PRIMARY Modified Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU) |
29.45; 30.15; 16.35; 17.40 | — |
| PRIMARY Minnesota Nicotine Withdrawal Scale |
9.50; 9.10; 2.60; 2.70 | — |
| PRIMARY Exhaled Breath Carbon Monoxide (CO) |
2.45; 2.80 | — |
Summary
This clinical trial studies the effect of free-base compared with nicotine salt based e-liquids on electronic cigarette (EC) puffing behavior, abuse liability, and deposition and absorption of nicotine in the respiratory tract and rate of uptake in the brain in current EC smokers. The results from this study may provide much needed scientific information to public health officials and regulators.
Eligibility Criteria
Inclusion Criteria
- A current exclusive e-cigarette user (>= 1 vaping bout per day) for at least the past 6 months (confirmed by NicAlert saliva testing strip)
- Between 21-50 years old
- Willing to provide informed consent and abstain from all tobacco and nicotine use for at least 12 hours prior to visits 2 and 3
- Willing to participate in 3 laboratory visits
- Read and speak English
- If utilizing study provided rideshare services, will need to live within 20 miles of Wake Forest University
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 (as indicated by urine pregnancy test at the start of each laboratory visit), planning to become pregnant, or breastfeeding (women only)
- Use of other tobacco products (e.g., cigarette, cigar, etc.) > 5 days in the past month
- Currently engaging in a tobacco product cessation attempt
Data sourced from ClinicalTrials.gov (NCT05455086). 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.