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

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

Interventions

BEHAVIORAL

Avoidance

Abstain from caffeine products

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

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

Questionnaire Administration

Ancillary studies

BEHAVIORAL

Refrain from Smoking

Abstain from nicotine

OTHER

Vaping

Complete ad-libitum e-cigarette vaping

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.

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Patrick Tomko, PhD, CSCS · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NA

Purpose

BASIC_SCIENCE

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-08-01

Primary Completion

2027-12-31

Completion

2027-12-31

FDA Device

Yes

Countries

• United States

Study Locations