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RECRUITING Not applicable ClinicalTrials.gov

Evaluating the Effect of Nicotine on Eye Movements and Related Behaviors in Electronic Cigarette Users, NICS-EYES Trial

Sponsor: Ohio State University Comprehensive Cancer Center • ClinicalTrials.gov ID: NCT07604246

Registry updated: 2026-10-05
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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

  • Avoidance (Behavioral)
    Abstain from caffeine products
  • Biospecimen Collection (Procedure)
    Undergo blood sample collection
  • Cigarette Smoking (Behavioral)
    Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
  • Eye Movement Measurement (Procedure)
    Complete eye movement testing
  • Healthcare Activity (Behavioral)
    Obtain sleep
  • Questionnaire Administration (Other)
    Ancillary studies
  • Refrain from Smoking (Behavioral)
    Abstain from nicotine
  • Vaping (Other)
    Complete ad-libitum e-cigarette vaping
  • Standardized E-Cigarette Nicotine Administration (Drug)
    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.

Eligibility criteria

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

Conditions

Cigarette Smoking-Related Carcinoma

Locations

  • Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record