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

Conditions

• Cigarette Smoking-Related Carcinoma

Eligibility Criteria

Sex

ALL

Age

21 Years - 50 Years

Healthy Volunteers

Not accepted

Interventions

• Avoidance — BEHAVIORAL
  Abstain from caffeine products
• Biospecimen Collection — PROCEDURE
  Undergo blood sample collection
• Cigarette Smoking — BEHAVIORAL
  Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
• Eye Movement Measurement — PROCEDURE
  Complete eye movement testing
• Healthcare Activity — BEHAVIORAL
  Obtain sleep
• Questionnaire Administration — OTHER
  Ancillary studies
• Refrain from Smoking — BEHAVIORAL
  Abstain from nicotine
• Vaping — OTHER
  Complete ad-libitum e-cigarette vaping
• 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.

Study Details

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.

Key Dates

Start date

Aug 1, 2026

Status verified

May 2026

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

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.

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 ]

Central Contacts

• The Ohio State University Comprehensive Cancer Center
  800-293-5066
  [email protected]

Locations (1)

Find similar trials in Columbus, OH

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