350 Participants Needed

Nicotine Levels in E-Cigarettes for Tobacco-Related Cancer Prevention

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ohio State University Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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.12345

Why 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?

TL

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

I can avoid nicotine, tobacco, and marijuana for 12 hours before visits.
I am 21-24, use e-cigarettes only, and have smoked less than 10 cigarettes ever.
I am a smoker aged 25-65 and interested in trying an electronic cigarette.

Exclusion Criteria

I do not use tobacco products daily except for e-cigarettes or cigarettes.
Currently attempting to quit nicotine or tobacco products
I have not been diagnosed with new or worsening heart problems in the last 3 months.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

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.

8 lab visits, up to 4 hours each
8 visits (in-person)

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.

1 lab visit, up to 6 hours
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

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?
28Treatment groups
Experimental Treatment
Group I: Phase 2, Arm 9 (High, 45%, S)Experimental Treatment4 Interventions
Group II: Phase 2, Arm 8 (Low, 25%, R/S)Experimental Treatment4 Interventions
Group III: Phase 2, Arm 7 (Low, 25%, S)Experimental Treatment4 Interventions
Group IV: Phase 2, Arm 6 (High, 25%, R/S)Experimental Treatment4 Interventions
Group V: Phase 2, Arm 5 (High, 25%, S)Experimental Treatment4 Interventions
Group VI: Phase 2, Arm 4 (Low, 5%, R/S)Experimental Treatment4 Interventions
Group VII: Phase 2, Arm 3 (Low, 5%, S)Experimental Treatment4 Interventions
Group VIII: Phase 2, Arm 20 (Low, 85%, R/S)Experimental Treatment4 Interventions
Group IX: Phase 2, Arm 2 (High, 5%, R/S)Experimental Treatment4 Interventions
Group X: Phase 2, Arm 19 (Low, 85%, S)Experimental Treatment4 Interventions
Group XI: Phase 2, Arm 18 (High, 85%, R/S)Experimental Treatment4 Interventions
Group XII: Phase 2, Arm 17 (High, 85%, S)Experimental Treatment4 Interventions
Group XIII: Phase 2, Arm 16 (Low, 65%, R/S)Experimental Treatment4 Interventions
Group XIV: Phase 2, Arm 15 (Low, 65%, S)Experimental Treatment4 Interventions
Group XV: Phase 2, Arm 14 (High , 65%, R/S)Experimental Treatment4 Interventions
Group XVI: Phase 2, Arm 13 (High , 65%, S)Experimental Treatment4 Interventions
Group XVII: Phase 2, Arm 12 (Low, 45%, R/S)Experimental Treatment4 Interventions
Group XVIII: Phase 2, Arm 11 (Low, 45%, S)Experimental Treatment4 Interventions
Group XIX: Phase 2, Arm 10 (High, 45%, R/S)Experimental Treatment4 Interventions
Group XX: Phase 2, Arm 1 (High, 5%, S)Experimental Treatment4 Interventions
Group XXI: Phase 1, Arm 8 (Low, NicH+, R/S)Experimental Treatment4 Interventions
Group XXII: Phase 1, Arm 7 (Low, NicH+, S)Experimental Treatment4 Interventions
Group XXIII: Phase 1, Arm 6 (High, NicH+, R/S)Experimental Treatment4 Interventions
Group XXIV: Phase 1, Arm 5 (High, NicH+, S)Experimental Treatment4 Interventions
Group XXV: Phase 1, Arm 4 (Low, Nic, R/S)Experimental Treatment4 Interventions
Group XXVI: Phase 1, Arm 3 (Low, Nic, S)Experimental Treatment4 Interventions
Group XXVII: Phase 1, Arm 2 (High, Nic, R/S)Experimental Treatment4 Interventions
Group XXVIII: Phase 1, Arm 1 (High, Nic, S)Experimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials
350
Recruited
295,000+

Published Research Related to This Trial

Between 2012 and 2017, there was a nearly sixfold increase in calls to the British Columbia Poison Centre regarding exposures to electronic nicotine delivery systems (ENDS), primarily due to accidental ingestions in young children, particularly those aged 4 years or less.
Of the 186 unique exposures recorded, 46.8% resulted in reported symptoms, highlighting the need for regulatory measures to reduce children's access to ENDS and improve product safety through better labeling and packaging.
Electronic cigarette exposures reported to the British Columbia Drug and Poison Information Centre: an observational case series.Choi, A., Le, M., Rahim, T., et al.[2022]
E-cigarettes (ENDS) are considered a potential harm reduction tool for smoking cessation, as they do not produce harmful combustion products like traditional cigarettes, but they still deliver various harmful chemicals that raise concerns for cardiovascular and respiratory health.
There is a lack of long-term safety data on ENDS, and while they may help some adults quit smoking, their rising popularity among youth poses a risk of nicotine addiction, highlighting the need for careful regulation and clinician awareness.
E-Cigarettes Reexamined: Product Toxicity.Pipe, AL., Mir, H.[2022]
In a randomized trial involving 68 adult smokers, those using electronic nicotine delivery systems (ENDS) showed a significant reduction in cigarette smoking compared to a control group, indicating potential efficacy in smoking cessation.
Participants using the higher nicotine (24 mg) ENDS were more likely to continue using the product and make independent purchases, suggesting that higher nicotine delivery may enhance user engagement and support smoking reduction efforts.
A Naturalistic, Randomized Pilot Trial of E-Cigarettes: Uptake, Exposure, and Behavioral Effects.Carpenter, MJ., Heckman, BW., Wahlquist, AE., et al.[2018]

Citations

Electronic Nicotine Delivery Systems (โ€œE-Cigarettesโ€)Compared to tobacco cigarettes, available evidence suggests that e-cigarettes are often substantially lower in toxic content, cytotoxicity, associated adverse ...
Electronic Nicotine Delivery Systems (ENDS) UseNCI supports research to understand the potential impact of ENDS use on both individual and population health, as it relates to cancer control and prevention.
Electronic Nicotine-Delivery Systems for Smoking CessationThe addition of e-cigarettes to standard smoking-cessation counseling resulted in greater abstinence from tobacco use among smokers than smoking ...
Electronic cigarette use, related health outcomes and ...E-cigarette use is associated with several adverse acute health outcomes; there is currently insufficient longitudinal evidence to predict ...
Electronic Nicotine Delivery Systems: An Updated Policy ...While ENDS emit fewer carcinogens than combustible tobacco, preliminary evidence links ENDS use to DNA damage and inflammation, key steps in cancer development.
Electronic nicotine delivery systems (ENDS)The FDA has classified PG as safe for oral intake, but the effects of its inhalation are still unknown. The cellular effects of direct contact are unclear, but ...
Tobacco: E-cigarettesE-cigarette emissions typically contain nicotine and other toxic substances that are harmful to both users and non-users who are exposed to the aerosols second- ...
E-Cigarettes, Vapes, and other Electronic Nicotine Delivery ...Get an overview of FDA regulation of e-cigarettes, vapes, and other electronic nicotine delivery systems. You can also find statistics about ...
The beginning of ENDS (electronic nicotine delivery systems)Electronic nicotine delivery systems (ENDS), commonly known as e-cigarettes, are battery-operated devices that produce aerosols by vaporizing e-liquids.
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