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

18. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

25

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Spojené státy
    • Ohio
      • Columbus, Ohio, Spojené státy, 43210
        • Ohio State University Comprehensive Cancer Center
        • Kontakt:
        • Vrchní vyšetřovatel:
          • Patrick Tomko, PhD, CSCS

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Základní věda
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: Administrace dotazníku
Pomocná studia
Postup: Sbírka biovzorků
Podstoupit odběr vzorku krve
Ostatní jména:
  • Sběr biologických vzorků
  • Odebrán biovzorek
  • Sbírka vzorků
Behaviorální: Avoidance
Abstain from caffeine products
Ostatní jména:
  • Avoided
Behaviorální: Cigarette Smoking
Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
Postup: Eye Movement Measurement
Complete eye movement testing
Behaviorální: Healthcare Activity
Obtain sleep
Ostatní jména:
  • Činnost zdravotní péče
  • Zdravotní péče
  • Health Care
Behaviorální: Refrain from Smoking
Abstain from nicotine
Ostatní jména:
  • Abstain from Smoking
  • Abstinence from Cigarette Smoking
  • Abstinence from Cigarettes
  • Smoking Abstinence
Jiný: Vaping
Complete ad-libitum e-cigarette vaping
Ostatní jména:
  • Vape
Lék: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in prosaccade latency and velocity
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Electronic (E)-cigarette intensity demand
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Ohio State University Comprehensive Cancer Center

Vyšetřovatelé

  • Vrchní vyšetřovatel: Patrick Tomko, PhD, CSCS, Ohio State University Comprehensive Cancer Center

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

1. srpna 2026

Primární dokončení (Odhadovaný)

31. prosince 2027

Dokončení studie (Odhadovaný)

31. prosince 2027

Termíny zápisu do studia

První předloženo

18. května 2026

První předloženo, které splnilo kritéria kontroly kvality

18. května 2026

První zveřejněno (Aktuální)

22. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

22. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

18. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • OSU-26020
  • NCI-2026-03442 (Identifikátor registru: CTRP (Clinical Trial Reporting Program))
  • STUDY20252989

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ano

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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Podmínky

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Drogové intervence

Doplňky stravy

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