Evaluating the Effect of Nicotine on Eye Movements and Related Behaviors in Electronic Cigarette Users, NICS-EYES Trial
18 maj 2026 uppdaterad av: 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
25
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: The Ohio State University Comprehensive Cancer Center
- Telefonnummer: 800-293-5066
- E-post: OSUCCCClinicaltrials@osumc.edu
Studieorter
-
-
Ohio
-
Columbus, Ohio, Förenta staterna, 43210
- Ohio State University Comprehensive Cancer Center
-
Kontakt:
- Patrick Tomko, PhD, CSCS
- Telefonnummer: 614-293-8152
- E-post: patrick.tomko@osumc.edu
-
Huvudutredare:
- Patrick Tomko, PhD, CSCS
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Grundläggande vetenskap
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
Sidostudier
Genomgå blodprovtagning
Andra namn:
Abstain from caffeine products
Andra namn:
Complete self-administer 5% nicotine non-mint menthol pods via an e-cigarette device
Complete eye movement testing
Obtain sleep
Andra namn:
Abstain from nicotine
Andra namn:
Complete ad-libitum e-cigarette vaping
Andra namn:
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in prosaccade latency and velocity
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Electronic (E)-cigarette intensity demand
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Patrick Tomko, PhD, CSCS, Ohio State University Comprehensive Cancer Center
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
1 augusti 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
18 maj 2026
Först inskickad som uppfyllde QC-kriterierna
18 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Undersökningstekniker
- Kliniska laboratorietekniker
- Diagnostiska tekniker och procedurer
- Diagnos
- Tillverkat material
- Teknik, industri och jordbruk
- Rökenheter
- Patientvårdshantering
- Provhantering
- Elektroniska nikotinleveranssystem
- Hälsovård
- SAV4 protein, Arabidopsis
Andra studie-ID-nummer
- OSU-26020
- NCI-2026-03442 (Registeridentifierare: CTRP (Clinical Trial Reporting Program))
- STUDY20252989
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Ja
produkt tillverkad i och exporterad från U.S.A.
Nej
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