Nicotine Effects for E-Cigarette Users
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines how nicotine from e-cigarettes affects eye movements and behavior. The researchers aim to understand the brain's reaction to nicotine and to develop better methods for measuring addiction in e-cigarette users. Participants will use e-cigarettes with standardized nicotine levels and undergo eye movement testing. Individuals who have used e-cigarettes with nicotine daily for at least six months and are willing to visit the lab twice may be suitable for this study. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research on nicotine addiction.
Will I have to stop taking my current medications?
If you are taking medications that affect pupil size or eye movements, like anticholinergics, stimulants, or antipsychotics, you may not be eligible to participate in the trial.
What prior data suggests that this nicotine administration is safe for e-cigarette users?
Research has shown that e-cigarettes, like those used in this study, generally pose less risk than regular cigarettes because they contain fewer harmful chemicals. However, some studies found that e-cigarette use can still expose individuals to toxic substances, potentially increasing the risk of lung and heart problems over time.
Overall, e-cigarettes may serve as a safer option for those attempting to quit smoking regular cigarettes. Yet, they can still lead to nicotine addiction, which affects the body in other ways. While e-cigarettes are usually well-tolerated, they are not without risk.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores how standardized nicotine delivery through e-cigarettes affects users, specifically focusing on eye movement and nicotine absorption. Unlike traditional cigarette smoking, this method allows for precise control of nicotine intake, which can provide clearer insights into its physiological effects. By standardizing the puffing routine and measuring the outcomes, researchers hope to better understand the impact of e-cigarette use on the body, potentially informing safer usage guidelines or new cessation strategies.
What evidence suggests that standardized e-cigarette nicotine administration is effective for studying eye movements in e-cigarette users?
Research shows that nicotine in e-cigarettes can alter eye movement and behavior. Nicotine in the blood affects eye movement and focus. This trial will investigate these effects by having participants self-administer nicotine through a standardized e-cigarette routine. Studies suggest that changes in eye movements might clarify why nicotine is addictive. While e-cigarettes can help some people quit smoking, they can also be highly addictive, similar to regular cigarettes. Understanding these eye movement changes could lead to better ways to measure addiction in e-cigarette users.34678
Who Is on the Research Team?
Patrick Tomko, PhD, CSCS
Principal Investigator
Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults aged 21-50 who have used nicotine e-cigarettes daily for at least 6 months, can avoid nicotine for 12 hours before visits, speak English fluently, and are willing to attend two lab sessions and complete all study steps.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants self-administer 5% nicotine non-mint menthol pods via an e-cigarette device using a guided standardized puffing routine over 5 minutes on visit one and at least 48 hours later on visit two
Follow-up
Participants are monitored for changes in oculomotor performance and plasma nicotine concentrations
What Are the Treatments Tested in This Trial?
Interventions
- Standardized E-Cigarette Nicotine Administration
Trial Overview
The study looks at how nicotine from e-cigarettes affects eye movements and related behaviors. Participants will be asked to vape or refrain from vaping, provide samples, answer questionnaires, and have their eye movements measured in a controlled setting.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants abstain from nicotine for at least 12 hours and caffeine products for at least 2 hours, as well as obtain sleep for at least 5-6 hours before each study visit. Participants self-administer 5% nicotine mint menthol via an e-cigarette device using a guided standardized puffing routine over 5 minutes on visit one. At least 48 hours later, participants complete the same 5-minute guided puffing routine as in visit one and then use an e-cigarette as they normally would over 30 minutes at visit two. Participants also complete eye movement testing and undergo blood sample collection during each visit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University Comprehensive Cancer Center
Lead Sponsor
Citations
Effectiveness of e-cigarettes as a stop smoking intervention in ...
This systematic review aims to identify the benefits and harms of electronic cigarettes (e-cigarettes) as a smoking cessation aid in adults (aged ≥ 18 ...
Electronic Nicotine-Delivery Systems for Smoking Cessation
In the control group, 3.9% reported using e-cigarettes, 63.6% nicotine-replacement therapy, and 4.1% other smoking-cessation drug therapy. Use ...
Electronic cigarettes and health outcomes - PMC - NIH
Use of nicotine e-cigarettes increases the risks of addiction, poisoning, toxicity from inhalation (including seizures) and trauma and burns.
Efficacy and Safety of E-Cigarette Use for Smoking Cessation
Overall, these data suggest e-cigarettes appear to be more efficacious than conventional nicotine replacement or behavioral smoking cessation therapies.
Disposable e-cigarettes and their nicotine delivery, usage ...
This study aimed to assess their addictive potential by examining puffing behaviors, subjective effects, and conducting laboratory investigations in an ...
Safety and Efficacy of Electronic Cigarettes: A Review - PMC
Electronic cigarettes are safer than conventional cigarettes and at least as safe as other approved nicotine replacement therapies.
Safety, efficacy and health impact of electronic nicotine ... - PMC
These broader assessments may cover topics such as the safety and efficacy of ENDS for tobacco smoking cessation or reduction, health-related outcomes ...
Risk and safety profile of electronic nicotine delivery systems ...
We found high-level evidence that ENDS exposes users to toxic substances; increases the risk of respiratory disease; leads to nicotine dependence; causes ...
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