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

NCT07604246 | Not Yet Recruiting FDA Device

• 3 other identifiers: OSU-26020NCI-2026-03442STUDY20252989
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cigarette Smoking-Related Carcinoma

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (4)

• Electronic (E)-cigarette intensity demand

  Up to completion of visit 2, up to 3 weeks

• E-cigarette Omax

  Up to completion of visit 2, up to 3 weeks

• E-cigarette demand breakpoint

  Up to completion of visit 2, up to 3 weeks

• Change in Minnesota Nicotine Withdrawal Scale scores

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

Study Arms (1)

Basic science (e-cigarette smoking, eye movement testing)

EXPERIMENTAL

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.

Behavioral: Avoidance; Procedure: Biospecimen Collection; Behavioral: Cigarette Smoking; Procedure: Eye Movement Measurement; Behavioral: Healthcare Activity; Other: Questionnaire Administration; Behavioral: Refrain from Smoking; Other: Vaping; Drug: Standardized E-Cigarette Nicotine Administration

Interventions

Avoidance BEHAVIORAL

Abstain from caffeine products

Also known as: Avoided

Basic science (e-cigarette smoking, eye movement testing)

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Sample Collection, Specimen Collection

Basic science (e-cigarette smoking, eye movement testing)

Cigarette Smoking BEHAVIORAL

Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device

Basic science (e-cigarette smoking, eye movement testing)

Eye Movement Measurement PROCEDURE

Complete eye movement testing

Basic science (e-cigarette smoking, eye movement testing)

Healthcare Activity BEHAVIORAL

Obtain sleep

Also known as: Health Care, Health Care Activity, Healthcare

Basic science (e-cigarette smoking, eye movement testing)

Questionnaire Administration OTHER

Ancillary studies

Basic science (e-cigarette smoking, eye movement testing)

Refrain from Smoking BEHAVIORAL

Abstain from nicotine

Also known as: Abstain from Smoking, Abstinence from Cigarette Smoking, Abstinence from Cigarettes, Smoking Abstinence

Basic science (e-cigarette smoking, eye movement testing)

Vaping OTHER

Complete ad-libitum e-cigarette vaping

Also known as: Vape

Basic science (e-cigarette smoking, eye movement testing)

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.

Basic science (e-cigarette smoking, eye movement testing)

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

Related Links

• The Jamesline

MeSH Terms

Interventions

SAV4 protein, Arabidopsis; Specimen Handling; Delivery of Health Care; Electronic Nicotine Delivery Systems

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Patrick Tomko, PhD, CSCS

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 18, 2026
• First Posted: May 22, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 22, 2026

Record last verified: 2026-05

Locations

US (1)