NCT07604246 · Ohio State University Comprehensive Cancer Center
Evaluating the Effect of Nicotine on Eye Movements and Related Behaviors in Electronic Cigarette Users, NICS-EYES Trial
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Avoidance
Abstain from caffeine products
PROCEDURE
Biospecimen Collection
Undergo blood sample collection
BEHAVIORAL
Cigarette Smoking
Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
PROCEDURE
Eye Movement Measurement
Complete eye movement testing
BEHAVIORAL
Healthcare Activity
Obtain sleep
OTHER
Questionnaire Administration
Ancillary studies
BEHAVIORAL
Refrain from Smoking
Abstain from nicotine
OTHER
Vaping
Complete ad-libitum e-cigarette vaping
DRUG
Standardized E-Cigarette Nicotine Administration
Participants use a e-cigarette 5.0% nicotine mint menthol pods. Visit 1: 5-minute guided puffing session (standardized protocol). Visit 2: 5-minute guided session followed by 30-minute ad-libitum vaping phase. Puffing topography monitored via SPA-Neo device.
Primary outcome measures
Change in prosaccade latency and velocity
Time frame: At baseline and at 5, 15 and 30 minutes post-nicotine administration, assessed up to completion of visit 2, up to 3 weeks
Reliability will be assessed using intraclass correlation coefficients (ICCs). Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures analysis of variance (ANOVA), as appropriate. Associations between oculomotor outcomes and behavioral economic measures will be examined using correlation and regression analyses.
Change in antisaccade error rate and latency
Time frame: At baseline and at 5, 15 and 30 minutes post-nicotine administration
Reliability will be assessed using ICCs. Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between oculomotor outcomes and behavioral economic measures will be examined using correlation and regression analyses.
Change in smooth pursuit gain across two laboratory sessions
Time frame: At baseline and at 5, 15 and 30 minutes post-nicotine administration
Reliability will be assessed using ICCs. Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between oculomotor outcomes, plasma nicotine concentrations, subjective ratings, and behavioral economic measures will be examined using correlation and regression analyses.
Change in oculomotor performance
Time frame: At baseline and at 5, 15 and 30 minutes post-nicotine administration
Reliability will be assessed using ICCs. Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between oculomotor outcomes, plasma nicotine concentrations, subjective ratings, and behavioral economic measures will be examined using correlation and regression analyses.
Plasma nicotine maximum concentration
Time frame: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between plasma nicotine concentrations and behavioral economic measures will be examined using correlation and regression analyses.
Time to maximum concentration of plasma nicotine
Time frame: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between plasma nicotine concentrations and behavioral economic measures will be examined using correlation and regression analyses.
Plasma nicotine area under the curve
Time frame: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between plasma nicotine concentrations and behavioral economic measures will be examined using correlation and regression analyses.
Subjective drug liking ratings
Time frame: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between subjective ratings and behavioral economic measures will be examined using correlation and regression analyses.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Age 21-50 years
- Daily use of nicotine-containing electronic cigarettes for ≥ 6 months
- Ability to abstain from nicotine for at least 12 hours prior to study visits
- Fluent in English
- Willingness to complete two in-person laboratory visits and all study procedures
- Ability to provide informed consent
Exclusion criteria
- Use of combustible cigarettes or other tobacco/nicotine products on more than 5 of the past 30 days
- Current enrollment in a nicotine cessation program or intent to quit in the next 30 days
- Neurological conditions affecting eye movements (seizure disorder, movement disorders, head injury with loss of consciousness)
- Normal or corrected-to-normal vision required; significant uncorrected visual impairment or ocular conditions affecting eye tracking
- Cardiovascular conditions for which nicotine use is contraindicated, substance use disorder (other than nicotine), or current nicotine cessation treatment
- Pregnancy or breastfeeding
- Current medications affecting pupil size or eye movements (anticholinergics, stimulants, antipsychotics)
- Any condition that, in the investigator's judgment, would interfere with safe participation
- Age younger than 21 years or older than 50 years
Where
- Columbus, Ohio
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 5, 2026 · Source of record for eligibility and locations