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

18 mai 2026 mis à jour par: Patrick Tomko, Ohio State University Comprehensive Cancer Center

Nicotine Effects on Eye Movements and Self-Report Measures (NICS-EYES)

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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

PRIMARY OBJECTIVE:

I. To determine the between-session reliability of oculomotor biomarkers during standardized nicotine administration in daily e-cigarette users.

SECONDARY OBJECTIVES:

I. To evaluate the association between oculomotor (OM) responses to nicotine and behavioral economic indices of reinforcing value.

II. To assess the relationship between oculomotor changes and nicotine withdrawal relief.

OUTLINE:

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 non-mint menthol pods 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.

Type d'étude

Interventionnel

Inscription (Estimé)

25

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Lieux d'étude

  • États-Unis
    • Ohio
      • Columbus, Ohio, États-Unis, 43210
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Chercheur principal:
          • Patrick Tomko, PhD, CSCS

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte

Accepte les volontaires sains

Non

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Science basique
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Autre: Gestion des questionnaires
Etudes annexes
Procédure: Collecte d'échantillons biologiques
Subir une collecte d'échantillons de sang
Autres noms:
  • Collecte d'échantillons biologiques
  • Spécimen biologique collecté
  • Collecte de spécimens
  • Collection d'échantillons
Comportemental: Avoidance
Abstain from caffeine products
Autres noms:
  • Avoided
Comportemental: Cigarette Smoking
Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
Procédure: Eye Movement Measurement
Complete eye movement testing
Comportemental: Healthcare Activity
Obtain sleep
Autres noms:
  • Activité de soins de santé
  • Soins de santé
  • Health Care
Comportemental: Refrain from Smoking
Abstain from nicotine
Autres noms:
  • Abstain from Smoking
  • Abstinence from Cigarette Smoking
  • Abstinence from Cigarettes
  • Smoking Abstinence
Autre: Vaping
Complete ad-libitum e-cigarette vaping
Autres noms:
  • Vape
Médicament: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in prosaccade latency and velocity
Délai: At baseline and at 5, 15 and 30 minutes post-nicotine administration, assessed up to completion of visit 2, up to 3 weeks
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.
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
Délai: At baseline and at 5, 15 and 30 minutes post-nicotine administration
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration
Change in smooth pursuit gain across two laboratory sessions
Délai: At baseline and at 5, 15 and 30 minutes post-nicotine administration
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration
Change in oculomotor performance
Délai: At baseline and at 5, 15 and 30 minutes post-nicotine administration
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.
At baseline and at 5, 15 and 30 minutes post-nicotine administration
Plasma nicotine maximum concentration
Délai: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between plasma nicotine concentrations and behavioral economic measures will be examined using correlation and regression analyses.
Up to completion of visit 2, up to 3 weeks
Time to maximum concentration of plasma nicotine
Délai: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between plasma nicotine concentrations and behavioral economic measures will be examined using correlation and regression analyses.
Up to completion of visit 2, up to 3 weeks
Plasma nicotine area under the curve
Délai: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between plasma nicotine concentrations and behavioral economic measures will be examined using correlation and regression analyses.
Up to completion of visit 2, up to 3 weeks
Subjective drug liking ratings
Délai: Up to completion of visit 2, up to 3 weeks
Changes will be evaluated using repeated-measures analyses, including mixed-effects models or repeated-measures ANOVA, as appropriate. Associations between subjective ratings and behavioral economic measures will be examined using correlation and regression analyses.
Up to completion of visit 2, up to 3 weeks

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Electronic (E)-cigarette intensity demand
Délai: Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
E-cigarette Omax
Délai: Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
E-cigarette demand breakpoint
Délai: Up to completion of visit 2, up to 3 weeks
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.
Up to completion of visit 2, up to 3 weeks
Change in Minnesota Nicotine Withdrawal Scale scores
Délai: From baseline and following nicotine administration, assessed up to completion of visit 2, up to 3 weeks
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.
From baseline and following nicotine administration, assessed up to completion of visit 2, up to 3 weeks

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Ohio State University Comprehensive Cancer Center

Les enquêteurs

  • Chercheur principal: Patrick Tomko, PhD, CSCS, Ohio State University Comprehensive Cancer Center

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

1 août 2026

Achèvement primaire (Estimé)

31 décembre 2027

Achèvement de l'étude (Estimé)

31 décembre 2027

Dates d'inscription aux études

Première soumission

18 mai 2026

Première soumission répondant aux critères de contrôle qualité

18 mai 2026

Première publication (Réel)

22 mai 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

22 mai 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

18 mai 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • OSU-26020
  • NCI-2026-03442 (Identificateur de registre: CTRP (Clinical Trial Reporting Program))
  • STUDY20252989

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Oui

produit fabriqué et exporté des États-Unis.

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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