Auditory Perceptual ImpairmentNicotineNCT04971954
Using Nicotine to Reverse Age-related Auditory Processing Deficits
A study testing Nicotine gum in people with Auditory Perceptual Impairment and Aging, run by University of California, Irvine at 2 sites in United States.
Trial summary
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Auditory Perceptual Impairment, Aging
- What is being tested?
- Nicotine gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Feb 2022to 31 Dec 2026
- Phase
- Interventional
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- between 18 and 85 years of age
- non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
- cognitive performance within two standard deviations of the CERAD mean
Who cannot join
- less than 18 or greater than 85 years of age
- deafness or excessive hearing loss
- smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
- history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
- regular use of prescription medications (excluding oral contraceptives)
- drug dependency
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Hearing and Speech Lab
Irvine, California, 92697
Fan-Gang Zeng, 9498249107, fzeng@uci.edu
- Recruiting
San Diego State University
San Diego, California, 92182
Xianhui (Kaye) Wang, PhD, 619-594-7746, kwang5@sdsu.edu
About this study
Official title: Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.
Read the detailed description
Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.
- Conditions
- Auditory Perceptual Impairment, Aging
- Being tested
- Nicotine gum, Placebo gum
- Keywords
- nicotine, biomarker
- Medical subject headings
- Auditory perceptual impairment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine gumOther
Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
Placebo gumOther
The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine gum | Experimental | Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication Receives: Other: Nicotine gum |
| Placebo gum | Placebo comparator | The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture. Receives: Other: Placebo gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hearing thresholds
Hearing thresholds in dB SPL will be measured as a function of sound frequency from 125 Hz to 8000 Hz in quiet or in noise.
Measured: 1 hour
Modulation detection
Amplitude-modulated sounds will be presented at 70 dB SPL or a comfortable level. The detection threshold in percent modulation depth (m= 0 to 100) will be recorded and converted into signal-to-noise ratios in dB (=20log(m)).
Measured: 1 hour
Envelope following responses
Electrophysiological responses will be recorded in response to amplitude or frequency-modulated sounds. The sounds will be presented at 70 dB SPL or a comfortable level. The response strength that is in synchrony with the modulation frequency in micro-Volts will be recorded.
Measured: 2 hours
EEG
EEG waveform will be recorded in terms of power spectral density (μV²/Hz).
Measured: 0.5 hours
Cortical evoked potential amplitude
Cortical evoked responses to sounds at 70 dB SPL or a comfortable level will be recorded. Cortical response peak amplitude will be measured in μV.
Measured: 1 hour
Cortical evoked potential latency
Cortical evoked responses to sounds at 70 dB SPL or a comfortable level will be recorded. Cortical response peak latency will be measured in mS.
Measured: 1 hour
Secondary outcomes (3)
Heart rate
Pulse rate in pulses per minute will be measured via pulse oximetry.
Measured: 10 minutes
Mood change
Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.
Measured: 10 minutes
Nicotine side effects
Side effects will be rated on a 5-point scale including: 1 = none (no symptoms at all); 2 = mild (slight jitters); 3 = moderate (jittery, slight dull headache); 4 = moderately severe (jittery, dull headache, mild nausea); 5 = severe (jittery, dull or pounding headache, nausea, vomiting).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2021
- Study start1 Feb 2022
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Auditory Perceptual ImpairmentStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The nicotine and placebo gums will be administered in randomized, double-blind, counterbalanced fashion.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Fan-Gang Zeng, University of California, Irvine
- Investigators
- Fan-Gang Zeng, PhD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04971954
- Sponsor's protocol ID
- 20139964
- Other IDs
- 1R01AG067073
- Acronym
- Nicotine
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2021
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
PubMed 1932883Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
PubMed 2771064Pham CQ, Kapolowicz MR, Metherate R, Zeng FG. Nicotine enhances auditory processing in healthy and normal-hearing young adult nonsmokers. Psychopharmacology (Berl). 2020 Mar;237(3):833-840. doi: 10.1007/s00213-019-05421-x. Epub 2019 Dec 12.
PubMed 31832719
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology
- ClinicalTrials.gov ID
- NCT04971954
- Acronym / sponsor ID
- Nicotine / 20139964
- Conditions
- Auditory Perceptual Impairment, Aging
- Keywords
- nicotine, biomarker
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 22 Jul 2021 (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.
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.
Detailed description
Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- The nicotine and placebo gums will be administered in randomized, double-blind, counterbalanced fashion.
| Arm | Type | Receives |
|---|---|---|
| Nicotine gum | Experimental | Other: Nicotine gumNicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication |
| Placebo gum | Placebo comparator | Other: Placebo gumThe placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- between 18 and 85 years of age
- non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
- cognitive performance within two standard deviations of the CERAD mean
Key exclusion criteria (6 listed)
- less than 18 or greater than 85 years of age
- deafness or excessive hearing loss
- smokers with a score between 3 and 10 on the Fagerström index of smoking dependency
- history of psychiatric illness, neurological disorders, diabetes mellitus, renal failure, or cardiovascular disease
- regular use of prescription medications (excluding oral contraceptives)
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 gumNicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication | Other | Nicotine gum |
| Placebo gumThe placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture. | Other | Placebo gum |
Primary outcome
Hearing thresholds
Time frame: 1 hour
Hearing thresholds in dB SPL will be measured as a function of sound frequency from 125 Hz to 8000 Hz in quiet or in noise.
Modulation detection
Time frame: 1 hour
Amplitude-modulated sounds will be presented at 70 dB SPL or a comfortable level. The detection threshold in percent modulation depth (m= 0 to 100) will be recorded and converted into signal-to-noise ratios in dB (=20log(m)).
Envelope following responses
Time frame: 2 hours
Electrophysiological responses will be recorded in response to amplitude or frequency-modulated sounds. The sounds will be presented at 70 dB SPL or a comfortable level. The response strength that is in synchrony with the modulation frequency in micro-Volts will be recorded.
EEG
Time frame: 0.5 hours
EEG waveform will be recorded in terms of power spectral density (μV²/Hz).
Cortical evoked potential amplitude
Time frame: 1 hour
Cortical evoked responses to sounds at 70 dB SPL or a comfortable level will be recorded. Cortical response peak amplitude will be measured in μV.
Cortical evoked potential latency
Time frame: 1 hour
Cortical evoked responses to sounds at 70 dB SPL or a comfortable level will be recorded. Cortical response peak latency will be measured in mS.
3 secondary outcomes
Heart rate
Time frame: 10 minutes
Mood change
Time frame: 10 minutes
Nicotine side effects
Time frame: 10 minutes
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 19 Oct 2026.
- Background: PubMed 1932883Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x.
- Background: PubMed 2771064Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159.
- Results publication: PubMed 31832719Pham CQ, Kapolowicz MR, Metherate R, Zeng FG. Nicotine enhances auditory processing in healthy and normal-hearing young adult nonsmokers. Psychopharmacology (Berl). 2020 Mar;237(3):833-840. doi: 10.1007/s00213-019-05421-x. Epub 2019 Dec 12.
- Individual participant dataSharing planned: No
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.
Fan-Gang Zeng, PhD principal investigator
University of California, Irvine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nicotine gum in people with Auditory Perceptual Impairment and Aging, run by University of California, Irvine at 2 sites 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 3 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 19 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 2 sites 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.
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 Fan-Gang Zeng (9498249107, fzeng@uci.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hearing thresholds (time frame: 1 hour). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04971954, which also lists 3 linked publications.
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 19 Oct 2026; AzTrials last refreshed its copy on 27 Oct 2026.