A Phase 1/2 interventional study of Nicotine polacrilex gum 4 mg and Placebo gum in Tinnitus and Chronic Subjective Tinnitus, sponsored by Xianhui Wang. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by Xianhui Wang · Phase 1/2, Interventional, and Basic science
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.
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'.
421 studies on the registry are indexed under Tinnitus; 88 are open to participants now.
This study's planned enrollment of 20 is below the median of 59 across 346 interventional studies indexed under Tinnitus.
Browse Tinnitus studies →This is the only study on the registry with Xianhui Wang as lead sponsor.
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Exclusion Criteria:
Single 4 mg dose of nicotine polacrilex gum, chewed for 20 minutes at 1 Hz using the standardized administration protocol.
Drug: Nicotine polacrilex gum 4 mg
Flavor-, color-, shape-, and texture-matched placebo gum, chewed under the identical protocol.
Other: Placebo gum
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.
Also known as: Nicorette
Flavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol.
Auditory oddball P3 amplitude after administration (nicotine vs placebo)
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.
Time frame: Up to 2 hours after gum administration
Auditory oddball P3 latency after administration (nicotine vs placebo)
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.
Time frame: Up to 2 hours after gum administration
Auditory oddball target-detection accuracy after administration (nicotine vs placebo)
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.
Time frame: Up to 2 hours after gum administration
Auditory oddball reaction time after administration (nicotine vs placebo)
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.
Time frame: Up to 2 hours after gum administration
Resting-state EEG spectral power and aperiodic (1/f) slope after administration (nicotine vs placebo)
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.
Time frame: Up to 2 hours after gum administration
Auditory oddball sensitivity (d') after administration (nicotine vs placebo)
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.
Time frame: Up to 2 hours after gum administration
Within-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo)
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.
Time frame: Baseline (pre-administration) and up to 2 hours after gum administration
Tinnitus Handicap Inventory (THI) score
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).
Time frame: Baseline (pre-administration, first session)
Tinnitus Functional Index (TFI) score
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).
Time frame: Baseline (pre-administration, first session)
Pure-tone audiometry (0.25-12 kHz)
Baseline hearing thresholds, collected once at the start of the first session.
Time frame: Baseline (pre-administration, first session)
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Nicotine Chewing Gum