TinnitusPhase 1/2NCT07772089
Acute Nicotine Gum and Tinnitus Loudness in Non-Smoking Adults
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 tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with chronic tinnitus. Nicotine acts on brain nicotinic acetylcholine receptors that regulate the balance of excitation and inhibition in auditory and attention networks, and may… 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
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Mar 2026to 3 Aug 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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.
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 Psychoacoustic Tinnitus Loudness and Selective Attention in Non-Smoking Adults With Chronic Subjective Tinnitus
This study tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with chronic tinnitus. Nicotine acts on brain nicotinic acetylcholine receptors that regulate the balance of excitation and inhibition in auditory and attention networks, and may temporarily quiet the phantom sound while improving the ability to focus on relevant sounds. Using a double-blind, placebo-controlled, within-subject crossover design, each participant attended two sessions and received a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. The primary measure was the within-session change in a psychoacoustic match of tinnitus loudness; auditory selective attention was a secondary measure.
Read the detailed description
Background: Tinnitus is associated with excitatory-inhibitory imbalance across auditory, attentional, and limbic circuits. Nicotinic acetylcholine receptor modulation is a candidate dual-target mechanism, but it has not been evaluated for tinnitus in humans.
Dose and protocol: The 4 mg dose and a standardized administration protocol (continuous chewing for 20 minutes at one chew per second, paced by a 1 Hz auditory cue, with saliva retained and spitting minimized to maximize buccal absorption) were established in a preceding gum optimization study in non-smokers.
Trial design: Randomized, double-blind, placebo-controlled, within-subject crossover. Each participant attended two sessions on separate days, separated by a washout of at least 72 hours, receiving nicotine gum at one session and matched placebo gum at the other in randomized 1:1 order. Allocation was concealed with sequentially numbered, opaque, sealed envelopes; an independent examiner prepared the gum and participants wore a blindfold during administration.
Outcomes: The primary outcome was the within-session change (post minus pre) in psychoacoustic tinnitus loudness match, compared between the nicotine and placebo sessions. The secondary outcome was the within-session change in auditory selective attention (Coordinate Response Measure percent correct). Additional pre-specified measures were pure-tone audiometry, the Tinnitus Handicap Inventory, and the Tinnitus Functional Index. Outcomes were analyzed with generalized linear mixed models.
- Conditions
- Tinnitus, Chronic Subjective Tinnitus
- Being tested
- Nicotine polacrilex gum 4 mg, Placebo gum
- Keywords
- Tinnitus, Nicotine, Nicotinic acetylcholine receptor, Selective attention, Nicotine polacrilex gum
- 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.
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.
Measured: Baseline (pre-administration) and up to 2 hours after gum administration
Secondary outcomes (1)
Auditory selective attention after administration (Coordinate Response Measure percent correct), nicotine vs placeb
Selective attention was assessed with the Coordinate Response Measure after gum administration and scored as the percentage of trials on which both the color and number were correctly identified; performance 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 posted19 Aug 2026
- Study start25 Mar 2026
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single-dose, two-period crossover: each participant received 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
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, Irvine
- Responsible party
- Sponsor
- Investigators
- Xianhui Wang, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07772089
- Sponsor's protocol ID
- IRB-25-0430
- Other IDs
- SEED Grant 2026
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data from this trial, together with a data dictionary defining each field, will be deposited in the Open Science Framework repository (osf.io) and made publicly available upon publication. The study protocol and statistical analysis plan will be deposited alongside the data. Before deposition, requests may be directed to the corresponding author (kwang5@sdsu.edu).
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 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 Psychoacoustic Tinnitus Loudness and Selective Attention in Non-Smoking Adults With Chronic Subjective Tinnitus
- ClinicalTrials.gov ID
- NCT07772089
- Acronym / sponsor ID
- IRB-25-0430
- Conditions
- Tinnitus, Chronic Subjective Tinnitus
- Keywords
- Tinnitus, Nicotine, Nicotinic acetylcholine receptor, Selective attention, Nicotine polacrilex gum
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- University of California, Irvine
- Study start
- 25 Mar 2026 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 19 Aug 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 tested whether a single dose of nicotine gum can reduce the loudness of tinnitus (ringing in the ears) in non-smoking adults with chronic tinnitus. Nicotine acts on brain nicotinic acetylcholine receptors that regulate the balance of excitation and inhibition in auditory and attention networks, and may temporarily quiet the phantom sound while improving the ability to focus on relevant sounds. Using a double-blind, placebo-controlled, within-subject crossover design, each participant attended two sessions and received a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. The primary measure was the within-session change in a psychoacoustic match of tinnitus loudness; auditory selective attention was a secondary measure.
Detailed description
Background: Tinnitus is associated with excitatory-inhibitory imbalance across auditory, attentional, and limbic circuits. Nicotinic acetylcholine receptor modulation is a candidate dual-target mechanism, but it has not been evaluated for tinnitus in humans.
Dose and protocol: The 4 mg dose and a standardized administration protocol (continuous chewing for 20 minutes at one chew per second, paced by a 1 Hz auditory cue, with saliva retained and spitting minimized to maximize buccal absorption) were established in a preceding gum optimization study in non-smokers.
Trial design: Randomized, double-blind, placebo-controlled, within-subject crossover. Each participant attended two sessions on separate days, separated by a washout of at least 72 hours, receiving nicotine gum at one session and matched placebo gum at the other in randomized 1:1 order. Allocation was concealed with sequentially numbered, opaque, sealed envelopes; an independent examiner prepared the gum and participants wore a blindfold during administration.
Outcomes: The primary outcome was the within-session change (post minus pre) in psychoacoustic tinnitus loudness match, compared between the nicotine and placebo sessions. The secondary outcome was the within-session change in auditory selective attention (Coordinate Response Measure percent correct). Additional pre-specified measures were pure-tone audiometry, the Tinnitus Handicap Inventory, and the Tinnitus Functional Index. Outcomes were analyzed with generalized linear mixed models.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Single-dose, two-period crossover: each participant received 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
Within-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo)
Time frame: 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.
1 secondary outcome
Auditory selective attention after administration (Coordinate Response Measure percent correct), nicotine vs placeb
Time frame: Up to 2 hours after gum administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data from this trial, together with a data dictionary defining each field, will be deposited in the Open Science Framework repository (osf.io) and made publicly available upon publication. The study protocol and statistical analysis plan will be deposited alongside the data. Before deposition, requests may be directed to the corresponding author (kwang5@sdsu.edu).
Related trials for Tinnitus
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RecruitingPhase 2
A Study of the Safety and Efficacy of TRTL-913 in Healthy Volunteers (Part A) and in Adults With Tinnitus (Part B)
Tinnitus
RecruitingObservational study
Lemborexant vs Clonidine vs Sedatives to Treat Insomnia in Chronic Pain Patients
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Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
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Enrolling by invitationObservational study
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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. This study is not recruiting at the moment.
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: finished, as of the sponsor's last update on 16 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo) (time frame: Baseline (pre-administration) and up to 2 hours after gum administration). 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 16 Oct 2026.