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Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus

3 novembre 2026 aggiornato da: San Diego State University

A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Auditory Oddball P3, Oddball Task Performance, and Resting-State EEG in Non-Smoking Adults With Chronic Tinnitus

This study tests whether a single dose of nicotine gum changes brain responses to sounds and the ability to detect target sounds in non-smoking adults with chronic tinnitus. In a double-blind, placebo-controlled, within-subject crossover design, each participant attends two sessions and receives a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. After gum administration, EEG is recorded at rest and during an active auditory oddball task. The primary measures are the P3 brain response (amplitude and latency) and oddball task accuracy and reaction time.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Relationship to prior registration: This trial is a separate, newly enrolled study conducted under the same IRB-approved protocol (San Diego State University IRB-25-0430) as the completed trial NCT07772089, which evaluated acute nicotine gum effects on tinnitus loudness and selective attention. Participants and data in this trial are collected independently of NCT07772089.

Population: Non-smoking adults aged 18-80 years with chronic subjective tinnitus, using the same eligibility criteria as NCT07772089.

Intervention and administration: A single 4 mg dose of nicotine polacrilex gum or flavor-matched placebo gum, chewed continuously for 20 minutes at one chew per second (paced by a 1 Hz auditory cue) with saliva retained, following the administration protocol established in the investigators' gum optimization study.

Design: Randomized, double-blind, placebo-controlled, within-subject crossover with two sessions on separate days separated by a washout of at least 72 hours. Session order is randomized 1:1 using a computer-generated sequence; allocation is concealed with sequentially numbered, opaque, sealed envelopes; gum is prepared by an independent examiner and participants are blindfolded during administration.

Procedures: At the start of the first session, pure-tone audiometry, the Tinnitus Handicap Inventory, the Tinnitus Functional Index, and a pre-administration tinnitus loudness match are completed. In each session, tinnitus loudness is matched before and after gum administration. All EEG and oddball measures are obtained after gum administration only. EEG is analyzed at electrodes Fz, Cz, Pz, and Oz: resting-state spectral power (delta, theta, alpha, beta, gamma) and aperiodic (1/f) slope, and P3 amplitude and latency to target tones in an active auditory oddball task, with concurrent behavioral accuracy, reaction time, and d'.

Tipo di studio

Interventistico

Iscrizione (Stimato)

20

Fase

  • Fase 2
  • Fase 1

Contatti e Sedi

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

Contatto studio

  • Nome: Xianhui Wang
  • Numero di telefono: 619-594-1151
  • Email: kwang5@sdsu.edu

Luoghi di studio

  • Stati Uniti
    • California
      • San Diego, California, Stati Uniti, 92182
        • San Diego State University

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

Da 18 anni a 80 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Non-smoking adult, defined as fewer than 100 cigarettes in a lifetime and none in the past year, with a Fagerstrom Test for Nicotine Dependence score of 2 or less and a negative urinary cotinine test
  • Chronic subjective tinnitus of at least 6 months' duration

Exclusion Criteria:

  • Current or recent tobacco or nicotine use
  • Pregnancy or breastfeeding
  • Unstable cardiovascular disease
  • Any condition precluding the psychoacoustic tasks

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: Randomizzato
  • Modello interventistico: Assegnazione incrociata
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Nicotine gum (4 mg)

Single 4 mg dose of nicotine polacrilex gum, chewed for 20 minutes at 1 Hz using the standardized administration protocol.
Droga: Nicotine polacrilex gum 4 mg

A single 4 mg dose (one 4 mg piece) of mint nicotine polacrilex gum, chewed continuously for 20 minutes at one chew per second with saliva retained.

Altri nomi:
  • Nicoretta
Comparatore placebo: Placebo gum

Flavor-, color-, shape-, and texture-matched placebo gum, chewed under the identical protocol.
Altro: Placebo gum

Flavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Auditory oddball P3 amplitude after administration (nicotine vs placebo)
Lasso di tempo: Up to 2 hours after gum administration

P3 (P300) peak amplitude in microvolts was measured from the event-related potential elicited by target tones during an active auditory oddball task performed after gum administration, at electrodes Fz, Cz, Pz, and Oz. Amplitude was compared between the nicotine and placebo sessions.
Up to 2 hours after gum administration
Auditory oddball P3 latency after administration (nicotine vs placebo)
Lasso di tempo: Up to 2 hours after gum administration

P3 (P300) peak latency in milliseconds was measured from the event-related potential elicited by target tones during an active auditory oddball task performed after gum administration, at electrodes Fz, Cz, Pz, and Oz. Latency was compared between the nicotine and placebo sessions.
Up to 2 hours after gum administration
Auditory oddball target-detection accuracy after administration (nicotine vs placebo)
Lasso di tempo: Up to 2 hours after gum administration

Behavioral accuracy (percentage of target tones correctly detected) in the active auditory oddball task performed after gum administration was compared between the nicotine and placebo sessions.
Up to 2 hours after gum administration
Auditory oddball reaction time after administration (nicotine vs placebo)
Lasso di tempo: Up to 2 hours after gum administration

Mean reaction time in milliseconds to correctly detected target tones in the active auditory oddball task performed after gum administration was compared between the nicotine and placebo sessions.
Up to 2 hours after gum administration

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Resting-state EEG spectral power and aperiodic (1/f) slope after administration (nicotine vs placebo)
Lasso di tempo: Up to 2 hours after gum administration

Resting-state EEG was recorded after gum administration. Absolute spectral power was computed for the delta, theta, alpha, beta, and gamma frequency bands, and the aperiodic (1/f) slope of the power spectrum was estimated, at electrodes Fz, Cz, Pz, and Oz. Values were compared between the nicotine and placebo sessions.
Up to 2 hours after gum administration
Auditory oddball sensitivity (d') after administration (nicotine vs placebo)
Lasso di tempo: Up to 2 hours after gum administration

Signal-detection sensitivity (d') computed from hits and false alarms in the active auditory oddball task performed after gum administration was compared between the nicotine and placebo sessions.
Up to 2 hours after gum administration

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Within-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo)
Lasso di tempo: Baseline (pre-administration) and up to 2 hours after gum administration

Tinnitus loudness was matched to the participant's tinnitus pitch by a method-of-adjustment procedure and expressed in dB sensation level. The pre-to-post change was compared between the nicotine and placebo sessions.
Baseline (pre-administration) and up to 2 hours after gum administration
Tinnitus Handicap Inventory (THI) score
Lasso di tempo: Baseline (pre-administration, first session)

The Tinnitus Handicap Inventory is a 25-item self-report questionnaire of tinnitus-related handicap. Each item is answered yes (4 points), sometimes (2 points), or no (0 points). The total score ranges from 0 to 100; higher scores indicate greater tinnitus handicap (a worse outcome).
Baseline (pre-administration, first session)
Tinnitus Functional Index (TFI) score
Lasso di tempo: Baseline (pre-administration, first session)

The Tinnitus Functional Index is a 25-item self-report questionnaire of the functional impact of tinnitus. Each item is rated on a 0-10 scale, and the overall score is the mean of the answered items multiplied by 10. The overall score ranges from 0 to 100; higher scores indicate more severe tinnitus impact (a worse outcome).
Baseline (pre-administration, first session)
Pure-tone audiometry (0.25-12 kHz)
Lasso di tempo: Baseline (pre-administration, first session)

Baseline hearing thresholds, collected once at the start of the first session.
Baseline (pre-administration, first session)

Collaboratori e investigatori

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

Sponsor

San Diego State University

Investigatori

  • Investigatore principale: Xianhui Wang, San Diego State University

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 (Stimato)

1 novembre 2026

Completamento primario (Stimato)

31 maggio 2027

Completamento dello studio (Stimato)

31 maggio 2027

Date di iscrizione allo studio

Primo inviato

9 ottobre 2026

Primo inviato che soddisfa i criteri di controllo qualità

9 ottobre 2026

Primo Inserito (Effettivo)

16 ottobre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 novembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

3 novembre 2026

Ultimo verificato

1 novembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • IRB-25-0430-EEG

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

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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