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Trial · NCT07877701

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

NCT07877701, Phase 1, Phase 2, Not yet recruiting, San Diego State University

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus. Trials, record NCT07877701. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07877701

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
NCT number
NCT07877701
Status
Not yet recruiting
Phases
Phase 1, Phase 2
Enrollment
20 participants, estimated
Lead sponsor
San Diego State University
Conditions
Tinnitus, Chronic Subjective Tinnitus
Interventions
Nicotine polacrilex gum 4 mg, Placebo gum
First posted
2026-10-16
Last updated
2026-11-06

Source ClinicalTrials.gov

Registered outcomes10

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryAuditory oddball P3 amplitude after administration (nicotine vs placebo)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.
PrimaryAuditory oddball P3 latency after administration (nicotine vs placebo)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.
PrimaryAuditory oddball target-detection accuracy after administration (nicotine vs placebo)Up to 2 hours after gum administrationBehavioral 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.
PrimaryAuditory oddball reaction time after administration (nicotine vs placebo)Up to 2 hours after gum administrationMean 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.
SecondaryResting-state EEG spectral power and aperiodic (1/f) slope after administration (nicotine vs placebo)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.
SecondaryAuditory oddball sensitivity (d') after administration (nicotine vs placebo)Up to 2 hours after gum administrationSignal-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.
OtherWithin-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo)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.
OtherTinnitus Handicap Inventory (THI) scoreBaseline (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).
OtherTinnitus Functional Index (TFI) scoreBaseline (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).
OtherPure-tone audiometry (0.25-12 kHz)Baseline (pre-administration, first session)Baseline hearing thresholds, collected once at the start of the first session.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests1

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

TestNamed as
Oddball Target DetectionPrimary outcome

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

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The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07877701

GET https://conductscience.org/api/trials/v1/NCT07877701/registered