Free-Base Nicotine or Nicotine Salt e-Liquids in Current E-Cigarette Smokers, PeloPET Study
2 other identifiers
interventional
21
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2021
CompletedStudy Start
First participant enrolled
March 23, 2022
CompletedFirst Posted
Study publicly available on registry
July 13, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2023
CompletedResults Posted
Study results publicly available
March 24, 2025
CompletedMarch 24, 2025
March 1, 2025
1.3 years
September 20, 2021
January 31, 2025
March 5, 2025
Conditions
Outcome Measures
Primary Outcomes (13)
PET/CT Imaging of the Head
Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the brain with total absorbed dose (TAD) of \[11C\]nicotine.
1.5 hours
PET/CT Imaging of the Chest
Evaluate effect of nicotine form (free-base vs nicotine salt base) on nicotine absorption and distribution in the respiratory tract with total absorbed dose (TAD) of \[11C\]nicotine.
1.5 hours
Puff Volume (mL)
Puffing topography data was captured by the study e-cigarette to determine the puff volume.
approx. 30 minutes
Puff Duration (s)
Puffing topography data was captured by the study e-cigarette to determine the puff duration.
approx. 30 minutes
Age of First Tobacco Use
Age of first use will be assessed using the tobacco use history questionnaire.
approx. 5 minutes
Years of Tobacco Use
Years of tobacco use will be assessed using the tobacco use history questionnaire.
approx. 5 minutes
Years of Regular Use of Nicotine/Tobacco Products
Years of regular use of nicotine/tobacco products will be assessed using the tobacco history questionnaire
approx. 5 minutes
Past 30 Day Use of Nicotine/Tobacco Products
Days used in the past 30 days of nicotine/tobacco products including cigars, cigarillos, little cigars, pipe tobacco, chewing tobacco, snuff, snus, EC/vape/mod/APV/e-hookah, and hookah tobacco.
approx. 5 minutes
Modified Cigarette Evaluation Questionnaire (mCEQ)
12-item modified Cigarette Evaluation Questionnaire (mCEQ) completed following e-cigarette self-administration to assess subjective responses. The 12-item mCEQ includes five subscales: Smoking Satisfaction, Psychological Reward, Aversion, Enjoyment of Respiratory Tract Sensations, and Craving Reduction, with items rated from 0 (not at all) to 6 (extremely likely). Scores for each subscale are calculated as the mean of the individual item responses or the single item. Higher scores indicate greater intensity on that scale.
approx. 5 minutes
Drug Effects Liking Questionnaire (DEQ)
An adapted version of the Drug Effects/Liking Questionnaire will assess the desire and liking of the study products. Five visual analog scale items ranging from 0 (not at all) to 100 (extremely) assessed wanting to vape the product again, liking the product, enjoying the product, finding the product pleasurable and satisfying. Higher scores indicate greater liking.
approx. 5 minutes
Modified Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form (QSU)
Urges/craving will be measured using a modified version of the Tiffany-Drobes Questionnaire of Smoking Urges: Brief Form. This is a 10-item measure where participants rate e-cigarette smoking-related items (All I want right now is an e-cigarette) on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Similar to previous studies, we will collapse the items into two previously identified factors (Factor 1: strong desire and intention to smoke an e-cigarette; Factor 2: anticipation of relief from withdrawal symptoms). Scores are calculated by summing the items and range from 5 to 35 with higher scores indicating greater craving to vape.
aprox. 5 minutes
Minnesota Nicotine Withdrawal Scale
Nicotine withdrawal will be assessed using the empirically validated 15-item version of the Minnesota Nicotine Withdrawal Scale (MNWS). Items were rated on a 5-point scale from 0 (none) to 4 (severe). This measure assesses smoking craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). MNWS is the sum of 8 items with scores ranging from 0 to 32 and MNWS Craving is a single item with scores ranging from 0 to 4, higher scores indicate a greater craving.
approx. 5 minutes
Exhaled Breath Carbon Monoxide (CO)
Exhaled breath carbon monoxide was collected before each scan with a handheld electrochemical device.
approx. 5 minutes
Study Arms (2)
Arm I (pronated e-liquid, unprotonated e-liquid
EXPERIMENTALVISIT 2: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET?CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT. VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest
Arm II (unprotonated e-liquid, protonated e-liquid
ACTIVE COMPARATORVISIT 2: Patients receive 1 puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored unprotonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest. VISIT 3: Patients receive 1 puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min head and 5 min chest PET/CT and then 0-15 min chest and 5 min head PET/CT. About 2 hours post initial PET/CT, patients receive a second puff of tobacco flavored or unflavored protonated e-liquid and undergo 0-15 min chest and 5 min head PET/CT and then 0-15 min head and 5 min chest PET/CT.
Interventions
Receive 1 puff of tobacco flavored protonated e-liquid
Undergo PET/CT
Undergo PET/CT
Ancillary studies
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Theodore L. Wagener
- Organization
- OhioSUCCC
Study Officials
- PRINCIPAL INVESTIGATOR
Theodore L Wagener, PhD
Ohio State University Comprehensive Cancer Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 20, 2021
First Posted
July 13, 2022
Study Start
March 23, 2022
Primary Completion
June 26, 2023
Study Completion
June 26, 2023
Last Updated
March 24, 2025
Results First Posted
March 24, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share