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NCT Number: NCT07604246

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

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Key information

Conditions

Cigarette Smoking-Related Carcinoma

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location contact

Patrick Tomko, PhD, CSCS

CONTACT

[email protected]

614-293-8152

Patrick Tomko, PhD, CSCS

PRINCIPAL_INVESTIGATOR

About this study

PRIMARY OBJECTIVE:

I. To determine the between-session reliability of oculomotor biomarkers during standardized nicotine administration in daily e-cigarette users.

SECONDARY OBJECTIVES:

I. To evaluate the association between oculomotor (OM) responses to nicotine and behavioral economic indices of reinforcing value.

II. To assess the relationship between oculomotor changes and nicotine withdrawal relief.

OUTLINE:

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 non-mint menthol pods 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Avoidance

Behavioral

Abstain from caffeine products

Other names: Avoided

Biospecimen Collection

Procedure

Undergo blood sample collection

Other names: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen 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

Other names: Health Care, Health Care Activity, Healthcare

Questionnaire Administration

Other

Ancillary studies

Refrain from Smoking

Behavioral

Abstain from nicotine

Other names: Abstain from Smoking, Abstinence from Cigarette Smoking, Abstinence from Cigarettes, Smoking Abstinence

Vaping

Other

Complete ad-libitum e-cigarette vaping

Other names: Vape

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Secondary outcomes

  1. Electronic (E)-cigarette intensity demand

    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 will be examined using correlation and regression analyses.

  2. E-cigarette Omax

    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 will be examined using correlation and regression analyses.

  3. E-cigarette demand breakpoint

    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 will be examined using correlation and regression analyses.

  4. Change in Minnesota Nicotine Withdrawal Scale scores

    Time frame: From baseline and following nicotine administration, assessed up to completion of visit 2, up to 3 weeks

    The Minnesota Nicotine Withdrawal Scale (MNWS) will asses nicotine withdrawal and craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal. Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations will be examined using correlation and regression analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

The Ohio State University Comprehensive Cancer Center

CONTACT

[email protected]

800-293-5066

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

Nicotine Effects on Eye Movements and Self-Report Measures (NICS-EYES)

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 22, 2026
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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