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Brain/Craving Response to Smoking Cues After Oral Nicotine Pouch Use

7 luglio 2026 aggiornato da: John Robert Monterosso, University of Southern California

Cue-Exposure Response Evaluation: Brain Reactivity to ONPs

Oral nicotine pouches (ONPs) are non-combustible nicotine products that may reduce cigarette craving and smoking cue-induced brain activity, supporting their potential as harm-reduction tools for adults who smoke cigarettes. This within-subject, repeated-measures study will evaluate the acute effects of a single 6 mg oral nicotine pouch on subjective craving and prefrontal neural responses to smoking-related cues using functional near-infrared spectroscopy (fNIRS). Participants will complete assessments before and after nicotine pouch administration following overnight nicotine abstinence to characterize changes in craving and neural cue reactivity.

Panoramica dello studio

Stato

Reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

This study will evaluate the acute effects of oral nicotine pouch (ONP) use on subjective cigarette craving and prefrontal neural responses to smoking-related cues among adult cigarette smokers. Although oral nicotine pouches do not involve combustion or inhalation, their effects on craving relief and neural cue reactivity following nicotine abstinence remain poorly understood. Characterizing these acute responses may improve understanding of the potential role of oral nicotine pouches as lower-risk nicotine products.

This is a single-arm, within-subject, repeated-measures study consisting of one baseline screening visit and one experimental visit. During the baseline visit, informed consent will be obtained, eligibility will be confirmed, demographic and tobacco use information will be collected, nicotine dependence will be assessed, and head circumference will be measured to determine appropriate functional near-infrared spectroscopy (fNIRS) cap sizing. Participants will also receive instructions to abstain from nicotine use for at least 12 hours before the experimental visit.

At the experimental visit, overnight nicotine abstinence will be verified before participants complete baseline assessments of subjective craving and nicotine withdrawal. Participants will then complete a standardized smoking cue reactivity task while prefrontal brain activity is recorded using functional near-infrared spectroscopy (fNIRS). Following completion of the baseline task, participants will self-administer one commercially available 6 mg oral nicotine pouch and complete a standardized 25-minute absorption period. Participants will then complete an identical post-pouch cue reactivity task with simultaneous fNIRS recording, followed by post-session assessments of craving, withdrawal, subjective product effects, and product perceptions.

The smoking cue reactivity task consists of repeated presentations of smoking-related and neutral visual cues, followed by guided imagery in which participants imagine smoking a cigarette or performing a comparable neutral behavior while holding the corresponding object. The task is administered before and after nicotine pouch administration using identical procedures to permit within-subject comparisons of neural and subjective responses.

Functional near-infrared spectroscopy is a non-invasive neuroimaging technique that measures changes in oxygenated and deoxygenated hemoglobin within cortical tissue as an indirect measure of neural activity. Brain activity will be recorded continuously throughout both cue reactivity task runs using a standardized prefrontal optode montage. Participants will be monitored throughout study procedures for discomfort, and study procedures will be discontinued if requested by the participant or if study staff determine continuation is not appropriate.

Tipo di studio

Interventistico

Iscrizione (Stimato)

45

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Stati Uniti
    • California
      • Los Angeles, California, Stati Uniti, 90089
        • Reclutamento
        • University of Southern California - 3641 Watt Way (HNB B22)
        • Contatto:

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto

Accetta volontari sani

Sì

Descrizione

Inclusion Criteria:

  • Age 21 years - 55 years
  • Self-reported use of cigarettes within the past 30 days

  • Biochemical confirmation of cigarette use:

    o Carbon monoxide (CO) breath sample ≥10 ppm

  • Fagerström Test for Nicotine Dependence (FTND) score ≥5, indicating moderate to high nicotine dependence
  • Fluent in English
  • Willing to try an oral nicotine pouch
  • Willing to abstain from nicotine for at least 12 hours prior to each experimental session

Exclusion Criteria:

  • Age younger than 21 years or older than 55 years

  • Biochemical evidence inconsistent with recent cigarette use:

    o CO breath sample <10 ppm

  • Expressed intent to reduce or quit nicotine use within the next 30 days
  • History of medical conditions contraindicated for nicotine use (e.g., uncontrolled hypertension, recent cardiac events)
  • Primary use of non-cigarette products (e.g., cigars, pipe tobacco, smokeless tobacco)
  • Prior use of oral nicotine products in their lifetime

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Scienza basilare
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Acute Oral Nicotine Pouch Administration
Adult cigarette smokers will complete one experimental session consisting of pre-pouch cue reactivity and subjective assessments, administration of a single 6 mg oral nicotine pouch, a standardized 25-minute absorption period, and identical post-pouch assessments. All participants complete the same study procedures and serve as their own control for pre- versus post-intervention comparisons.
Altro: Oral Nicotine Pouch
Participants will self-administer one commercially available 6 mg oral nicotine pouch following overnight nicotine abstinence. The pouch will be used for approximately 25 minutes before participants complete the post-pouch cue reactivity assessment.
Comportamentale: Smoking Cue Reactivity Task
Participants will complete a standardized smoking cue reactivity task before and after oral nicotine pouch administration. During each task, participants will view smoking-related and neutral images, complete guided imagination trials while holding either a cigarette or a neutral object, and undergo simultaneous functional near-infrared spectroscopy (fNIRS) to measure prefrontal brain activity.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Prefrontal Neural Cue Reactivity to Smoking-Related Cues Measured by Functional Near-Infrared Spectroscopy (fNIRS)
Lasso di tempo: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Prefrontal neural responses to smoking-related and neutral cues will be assessed using functional near-infrared spectroscopy (fNIRS). The primary outcome will be the within-subject change in oxygenated (HbO) and deoxygenated (HbR) hemoglobin concentration from the pre-pouch assessment to the post-pouch assessment. Larger positive HbO responses to smoking-related cues indicate greater neural cue reactivity.
Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Change in Subjective Cigarette Craving Measured by the Questionnaire of Smoking Urges-Brief (QSU-Brief)
Lasso di tempo: Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.
Subjective cigarette craving will be assessed using the Questionnaire of Smoking Urges-Brief (QSU-Brief). The QSU-Brief consists of 10 items, each rated on a 7-point Likert scale (1 = strongly disagree to 7 = strongly agree). Total scores range from 10 to 70, with higher scores indicating greater cigarette craving (worse outcome). The primary outcome will be the within-subject change in total QSU-Brief score from the pre-pouch assessment to the post-pouch assessment.
Baseline (pre-pouch) and approximately 25 minutes after administration of a 6 mg oral nicotine pouch (post-pouch) during the experimental session.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of Southern California

Investigatori

  • Investigatore principale: Natalia Peraza, University of Southern California
  • Cattedra di studio: John Monterosso, University of Southern California

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

30 aprile 2026

Completamento primario (Stimato)

1 luglio 2027

Completamento dello studio (Stimato)

1 agosto 2027

Date di iscrizione allo studio

Primo inviato

26 giugno 2025

Primo inviato che soddisfa i criteri di controllo qualità

7 luglio 2026

Primo Inserito (Effettivo)

13 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • UP-25-00525

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

De-identified individual participant data (IPD) that underlie the results reported in any future publications (e.g., self-reported craving scores, task performance metrics, and fNIRS-derived signal outputs) will be shared. The data will be stripped of all personally identifying information in accordance with HIPAA guidelines and made available upon reasonable request for academic and research purposes. A data dictionary and codebook will be provided to facilitate reuse. Access will be granted upon request to the corresponding author.

Periodo di condivisione IPD

Data will be made available within a target of 1 year after study completion.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • ICF
  • CODICE_ANALITICO
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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