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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorOhio State University Comprehensive Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Avoidance
  • Biospecimen Collection
  • Cigarette Smoking
  • Eye Movement Measurement
  • Healthcare Activity
  • Questionnaire Administration
  • Refrain from Smoking
  • Vaping
  • Standardized E-Cigarette Nicotine Administration

Treatment groups

25 Participants
are divided into 1 treatment group