Nicotine Levels in E-Cigarettes for Tobacco-Related Cancer Prevention
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to study how different types and levels of nicotine in e-cigarettes affect health risks and addiction potential. By examining these factors, researchers hope to identify the safest nicotine levels for e-cigarette users, potentially reducing tobacco-related cancer risks. The trial tests various e-liquids with different nicotine strengths and forms. It seeks participants who are either young adults using e-cigarettes exclusively for at least three months or older adults who smoke daily and are interested in trying e-cigarettes. Participants should not be trying to quit nicotine or tobacco and must refrain from using these products for at least 12 hours before visits. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to safer e-cigarette use.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using medications that affect the CYP2A6 enzyme, like rifampicin or dexamethasone.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that e-cigarettes contain toxic substances, though usually in lower amounts than regular cigarettes. This suggests they might be less harmful but not completely safe. The FDA has found that some ingredients in e-cigarettes, such as propylene glycol (PG), are safe to ingest, but their safety when inhaled remains unclear.
E-cigarettes often release nicotine and other harmful substances in the vapor, affecting both users and those nearby. This study aims to determine the best nicotine levels, but it does not guarantee the safety of the e-liquids tested.
In this trial, researchers are examining different e-liquids with varying nicotine strengths and types. Since the trial is marked as "Not Applicable" for its phase, predicting how well the treatment will be tolerated is difficult. Considering potential risks before joining a study like this is always wise.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores the potential of manipulating nicotine levels in e-cigarettes to prevent tobacco-related cancer. Traditional treatments for tobacco-related cancer focus on interventions after cancer development, such as surgery, chemotherapy, or radiation. This trial stands out by investigating a preventative measure, potentially reducing cancer risk before it starts. It examines different nicotine concentrations and forms, offering insights into how various e-cigarette compositions might influence cancer prevention. By understanding these effects, researchers hope to develop strategies that could lead to more effective cancer prevention methods.
What evidence suggests that this trial's treatments could be effective for tobacco-related cancer prevention?
Research has shown that e-cigarettes release fewer harmful chemicals than traditional cigarettes, potentially lowering the cancer risk associated with tobacco use. Studies have found that e-cigarettes can aid smoking cessation when combined with counseling. However, e-cigarette use still poses health risks, such as DNA damage and inflammation, which are linked to cancer. This trial will examine how different nicotine levels in e-cigarettes impact addiction and health. Participants in the various treatment arms will vape e-liquids with varying nicotine concentrations, forms, and isomers. Early results suggest that e-cigarettes might be less harmful than regular cigarettes, but research continues.16789
Who Is on the Research Team?
Theodore L. Wagener, PhD
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for individuals interested in the effects of e-cigarette nicotine on health. It's not specified who can't join, but typically participants should be healthy adults, possibly smokers or e-cigarette users.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase 1 (Study 1)
Participants are randomized to the order of 8 e-liquid combinations varying in nicotine concentration, form, and isomer. They participate in a 10-puff vaping session over 5 minutes followed by a 60-minute washout period and an ad libitum puffing session over 60 minutes at each lab visit.
Phase 2 (Study 2)
Participants are randomized to the order of 20 e-liquid combinations varying in concentration, FB fractions, and isomer. They take part in a 2-puff vaping session with each of the 20 study e-liquids with a 10-minute washout period between each session, grouped into two blocks of 10 separated by a 30-minute resting session.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Manipulating E-Cigarette Nicotine
Trial Overview
The study investigates how manipulating nicotine levels in e-cigarettes affects addiction potential and health risks. Participants will undergo vaping sessions, provide biospecimens, have their carbon monoxide levels measured, and complete surveys.
How Is the Trial Designed?
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Treatment groups
Experimental Treatment
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants vape 20 different study e-liquids varying in concentration (low \[20 mg/g\] or high \[50 mg/g\]), freebase nicotine percentage (5%, 25%, 45%, 65%, or 85%), and isomer (S-nicotine or R/S nicotine) using the e-cig study device during two visits.
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Participants are randomized to vape one out of the eight study e-liquids in a 10-puff vaping session over 5 minutes using the e-cig study device and then in an ad libitum puffing session over 60 minutes. The 8 e-liquids vary in nicotine concentration (low \[20 mg/g\] or high \[50 mg/g\]), form (Nic or NicH+), and isomer (S-nicotine or R/S nicotine).
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Published Research Related to This Trial
Citations
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5.
aacrjournals.org
aacrjournals.org/clincancerres/article/28/22/4861/710466/Electronic-Nicotine-Delivery-Systems-An-UpdatedElectronic Nicotine Delivery Systems: An Updated Policy ...
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