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

May 18, 2026 updated by: Patrick Tomko, Ohio State University Comprehensive Cancer Center

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Patrick Tomko, PhD, CSCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Basic science (e-cigarette smoking, eye movement testing)
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.
Other: Questionnaire Administration
Ancillary studies
Procedure: Biospecimen Collection
Undergo blood sample collection
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
  • Sample Collection
Behavioral: Avoidance
Abstain from caffeine products
Other Names:
  • Avoided
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 Names:
  • Health Care Activity
  • Healthcare
  • Health Care
Behavioral: Refrain from Smoking
Abstain from nicotine
Other Names:
  • Abstain from Smoking
  • Abstinence from Cigarette Smoking
  • Abstinence from Cigarettes
  • Smoking Abstinence
Other: Vaping
Complete ad-libitum e-cigarette vaping
Other Names:
  • Vape
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration, assessed up to completion of visit 2, up to 3 weeks
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration
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.
Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
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.
From baseline and following nicotine administration, assessed up to completion of visit 2, up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Patrick Tomko, PhD, CSCS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 18, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OSU-26020
  • NCI-2026-03442 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • STUDY20252989

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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