TinnitusPhase 1/2NCT07877701
Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
A Phase 1/2 study testing Nicotine polacrilex gum 4 mg in people with Tinnitus and Chronic Subjective Tinnitus, run by San Diego State University at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Tinnitus, Chronic Subjective Tinnitus
- What is being tested?
- Nicotine polacrilex gum 4 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current or recent tobacco or nicotine use
- Pregnancy or breastfeeding
- Unstable cardiovascular disease
- Any condition precluding the psychoacoustic tasks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Diego State University
San Diego, California, 92182
About this study
Official title: 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.
Read the detailed description
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'.
- Conditions
- Tinnitus, Chronic Subjective Tinnitus
- Being tested
- Nicotine polacrilex gum 4 mg, Placebo gum
- Keywords
- Tinnitus, Nicotine, P300, EEG, Auditory oddball, Nicotinic acetylcholine receptor
- Medical subject headings
- Tinnitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine polacrilex gum 4 mgDrug
Also called Nicorette
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.
Placebo gumOther
Flavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine gum (4 mg) | Experimental | Single 4 mg dose of nicotine polacrilex gum, chewed for 20 minutes at 1 Hz using the standardized administration protocol. Receives: Drug: Nicotine polacrilex gum 4 mg |
| Placebo gum | Placebo comparator | Flavor-, color-, shape-, and texture-matched placebo gum, chewed under the identical protocol. Receives: Other: Placebo gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 2 hours after gum administration
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 2 hours after gum administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TinnitusStudies of the same condition, open and under way.
- More trials run by San Diego State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-dose, two-period crossover: each participant receives a single 4 mg dose of nicotine polacrilex gum in one session and a flavor-matched placebo gum in the other, in randomized order, with at least 72 hours between sessions.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xianhui Wang, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07877701
- Sponsor's protocol ID
- IRB-25-0430-EEG
- Status last verified
- Nov 2026
- First submitted
- 9 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07877701
- Acronym / sponsor ID
- IRB-25-0430-EEG
- Conditions
- Tinnitus, Chronic Subjective Tinnitus
- Keywords
- Tinnitus, Nicotine, P300, EEG, Auditory oddball, Nicotinic acetylcholine receptor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 16 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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'.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-dose, two-period crossover: each participant receives a single 4 mg dose of nicotine polacrilex gum in one session and a flavor-matched placebo gum in the other, in randomized order, with at least 72 hours between sessions.
| Arm | Type | Receives |
|---|---|---|
| Nicotine gum (4 mg) | Experimental | Drug: Nicotine polacrilex gum 4 mgSingle 4 mg dose of nicotine polacrilex gum, chewed for 20 minutes at 1 Hz using the standardized administration protocol. |
| Placebo gum | Placebo comparator | Other: Placebo gumFlavor-, color-, shape-, and texture-matched placebo gum, chewed under the identical protocol. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Current or recent tobacco or nicotine use
- Pregnancy or breastfeeding
- Unstable cardiovascular disease
- Any condition precluding the psychoacoustic tasks
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine polacrilex gum 4 mgAlso: NicoretteA 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. | Drug | Nicotine gum (4 mg) |
| Placebo gumFlavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol. | Other | Placebo gum |
Primary outcome
Auditory oddball P3 amplitude after administration (nicotine vs placebo)
Time frame: 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.
Auditory oddball P3 latency after administration (nicotine vs placebo)
Time frame: 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.
Auditory oddball target-detection accuracy after administration (nicotine vs placebo)
Time frame: 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.
Auditory oddball reaction time after administration (nicotine vs placebo)
Time frame: 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.
2 secondary outcomes
Resting-state EEG spectral power and aperiodic (1/f) slope after administration (nicotine vs placebo)
Time frame: Up to 2 hours after gum administration
Auditory oddball sensitivity (d') after administration (nicotine vs placebo)
Time frame: Up to 2 hours after gum administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xianhui Wang principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nicotine polacrilex gum 4 mg in people with Tinnitus and Chronic Subjective Tinnitus, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xianhui Wang (619-594-1151, kwang5@sdsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory oddball P3 amplitude after administration (nicotine vs placebo) (time frame: Up to 2 hours after gum administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.