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.
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
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
Single group
Avoidance
BehavioralAbstain from caffeine products
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Cigarette Smoking
BehavioralComplete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
Eye Movement Measurement
Procedure/SurgeryComplete eye movement testing
Healthcare Activity
BehavioralObtain sleep
Questionnaire Administration
Other interventionAncillary studies
Refrain from Smoking
BehavioralAbstain from nicotine
Vaping
Other interventionComplete ad-libitum e-cigarette vaping
Standardized E-Cigarette Nicotine Administration
DrugParticipants 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.
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.
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.
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.
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.
Electronic (E)-cigarette intensity demand
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations will be examined using correlation and regression analyses.
E-cigarette Omax
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations will be examined using correlation and regression analyses.
E-cigarette demand breakpoint
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations will be examined using correlation and regression analyses.
Change in Minnesota Nicotine Withdrawal Scale scores
The Minnesota Nicotine Withdrawal Scale (MNWS) will asses nicotine withdrawal and craving, anger/irritability, anxiety, depressed mood, restlessness/difficulty concentrating, increased appetite, sleep problems, and somatic symptoms (nausea, constipation, sore throat, dizziness, coughing). Scores range from 0 to 4 with higher scores indicating greater levels of withdrawal. Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations will be examined using correlation and regression analyses.
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