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

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: Not yet recruiting
• Conditions: Cigarette Smoking-Related Carcinoma
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection; Behavioral: Avoidance; Behavioral: Cigarette Smoking; Procedure: Eye Movement Measurement; Behavioral: Healthcare Activity; Behavioral: Refrain from Smoking; Other: Vaping; Drug: Standardized E-Cigarette Nicotine Administration

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: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: The Ohio State University Comprehensive Cancer Center; Phone Number: 800-293-5066; Email: OSUCCCClinicaltrials@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center
      • Contact: Patrick Tomko, PhD, CSCS; Phone Number: 614-293-8152; Email: patrick.tomko@osumc.edu
      • Principal Investigator: Patrick Tomko, PhD, CSCS

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Change in prosaccade latency and velocity	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	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	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	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	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	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	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	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

Outcome Measure	Measure Description	Time Frame
Electronic (E)-cigarette intensity demand	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	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	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	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

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Patrick Tomko, PhD, CSCS, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: May 18, 2026
• First Submitted That Met QC Criteria: May 18, 2026
• First Posted (Actual): May 22, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 18, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Patient Care Management; Specimen Handling; Electronic Nicotine Delivery Systems; Delivery of Health Care; SAV4 protein, Arabidopsis
• Other Study ID 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