Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study (NCT05455086) | Clinical Trial Compass
CompletedNot Applicable
Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
United States21 participantsStarted 2022-03-23
Plain-language 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.
Who can participate
Age range
21 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study used PET/CT imaging of the head and chest to measure effects of e-cigarette use — what did that kind of radiation exposure mean for participants, and could those scans reveal anything relevant to my own situation?
2The trial compared free-base nicotine versus nicotine salt e-liquids in people who already vape — given that I may have a smoking-related cancer concern, is there anything in this completed study's findings that my care team thinks is worth knowing about how different e-cigarette formulas affect the body?
3Since this study tracked things like nicotine withdrawal symptoms and craving questionnaires alongside imaging, does that suggest quitting or switching products could affect my cancer risk or treatment outcomes in a way we should factor into my care plan?
4This trial is now completed but has no listed phase, which suggests it was more of an observational or measurement study rather than a treatment trial — so should I be looking at actual treatment trials instead, or does the data from this one inform any treatment decisions for me?
5The study measured exhaled carbon monoxide and detailed smoking history going back to first tobacco use — based on my own history, is there a certain level of exposure that would make my doctor recommend additional screening like the kind of imaging used in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PET/CT Imaging of the Head
Timeframe: 1.5 hours
2
PET/CT Imaging of the Chest
Timeframe: 1.5 hours
3
Puff Volume (mL)
Timeframe: approx. 30 minutes
4
Puff Duration (s)
Timeframe: approx. 30 minutes
5
Age of First Tobacco Use
Timeframe: approx. 5 minutes
6
Years of Tobacco Use
Timeframe: approx. 5 minutes
7
Years of Regular Use of Nicotine/Tobacco Products
Timeframe: approx. 5 minutes
8
Past 30 Day Use of Nicotine/Tobacco Products
Timeframe: approx. 5 minutes
Trial details
NCT IDNCT05455086
SponsorOhio State University Comprehensive Cancer Center