Nicotine Effects for E-Cigarette Users
What You Need to Know Before You Apply
What is the purpose of this trial?
This clinical trial evaluates the effect of nicotine on eye movements and related behaviors in people who use electronic (e)-cigarettes. Nicotine is an addictive, poisonous chemical found in tobacco. It can also be made in the laboratory. When it enters the body, nicotine causes an increased heart rate and the use of oxygen by the heart and a sense of well-being and relaxation. E-cigarettes are the most commonly used tobacco products in young adults in the United States. E-cigarettes deliver nicotine rapidly and the potential for addiction (abuse liability) is comparable to combustible cigarettes. The Food and Drug Administration uses a combination of testing including self-reported scales, withdrawal assessments and behavioral tasks to evaluate the abuse liability of a nicotine product. Research has shown that nicotine alters movement of the eye (oculomotor) and the amount of nicotine in the blood impacts the extent of oculomotor function impairment. Despite this evidence linking nicotine to oculomotor changes, it has not been studied as a reliable marker for abuse in e-cigarette users. Studying eye movements can provide information about how the brain responds to nicotine and may help researchers develop better, more objective ways to measure how addictive nicotine products in e-cigarette users.
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
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.