Recruiting

Nicotine

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT07604246

Conditions

Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Not accepted

Interventions

Avoidance

Biospecimen Collection

Cigarette Smoking

Eye Movement Measurement

Healthcare Activity

Study Details

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

Study ID

NCT07604246

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 50

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

Avoidance

Abstain from caffeine products

Biospecimen Collection

Undergo blood sample collection

Cigarette Smoking

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

Eye Movement Measurement

Complete eye movement testing

Healthcare Activity

Obtain sleep

Questionnaire Administration

Ancillary studies

Refrain from Smoking

Abstain from nicotine

Vaping

Complete ad-libitum e-cigarette vaping

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.

Primary outcome measure

  • 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 ]
  • Change in antisaccade error rate and latency [ Time Frame: 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 ]
  • Change in oculomotor performance [ Time Frame: 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 ]
  • Time to maximum concentration of plasma nicotine [ Time Frame: 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 ]
  • Subjective drug liking ratings [ Time Frame: Up to completion of visit 2, up to 3 weeks ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Patrick Tomko, PhD, CSCS

614-293-8152patrick.tomko@osumc.edu

Principal Investigator:

Patrick Tomko, PhD, CSCS

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Oct 5, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-06. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.