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

3. November 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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'.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Phase 2
  • Phase 1

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • San Diego, California, Vereinigte Staaten, 92182
        • San Diego State University

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Grundlegende Wissenschaft
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Nicotine gum (4 mg)

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

Andere Namen:
  • Nicorette
Placebo-Komparator: Placebo gum

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Auditory oddball P3 amplitude after administration (nicotine vs placebo)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Resting-state EEG spectral power and aperiodic (1/f) slope after administration (nicotine vs placebo)
Zeitfenster: 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)
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Within-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: Baseline (pre-administration, first session)

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

San Diego State University

Ermittler

  • Hauptermittler: Xianhui Wang, San Diego State University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. November 2026

Primärer Abschluss (Geschätzt)

31. Mai 2027

Studienabschluss (Geschätzt)

31. Mai 2027

Studienanmeldedaten

Zuerst eingereicht

9. Oktober 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

9. Oktober 2026

Zuerst gepostet (Tatsächlich)

16. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. November 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. November 2026

Zuletzt verifiziert

1. November 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • IRB-25-0430-EEG

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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