AgingEarly Phase 1NCT05018117
Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex
A Early Phase 1 study testing Nicotine gum in people with Aging, run by University of California, Berkeley at 1 site in United States.
Trial summary
Nicotine enhances auditory-cognitive function because it mimics the brain's system for "paying attention" to important sounds amid distractions (for example, understanding speech in a noisy environment). In part, nicotine does this by activating inhibitory neurons in the auditory cortex. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Nicotine gum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2022to 1 Apr 2025
- Phase
- Early Phase 1
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
Who cannot join
- 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
1 site in 1 country.
United States1 site
University of California, Berkeley
Berkeley, California, 94720
About this study
Nicotine enhances auditory-cognitive function because it mimics the brain's system for "paying attention" to important sounds amid distractions (for example, understanding speech in a noisy environment). In part, nicotine does this by activating inhibitory neurons in the auditory cortex. Since age-related hearing deficits result, in part, from the loss of inhibitory neurons in auditory cortex, this project will determine whether nicotine's effects can compensate for reduced inhibition in the aging auditory cortex and thereby restore auditory function.
The investigators will use functional magnetic resonance imaging (fMRI) to measure the selectivity of responses in auditory cortex to tones of various frequencies. The investigators will measure the effects of nicotine (administered as chewing gum) and aging on these fMRI response properties. The investigators hypothesize that frequency selectivity will decrease with aging and increase following nicotine administration.
- Conditions
- Aging
- Being tested
- Nicotine gum, Placebo gum
- Keywords
- nicotine, acetylcholine, functional magnetic resonance imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine gumDrug
Also called polacrilex
The effects of over-the-counter nicotine gum will be compared to a placebo gum
Placebo gumOther
The effects of over-the-counter nicotine gum will be compared to a placebo gum
| Study group | Role | What they receive |
|---|---|---|
| Young (18-28 years) participants - nicotine gum | Experimental | 6 mg nicotine gum, one time before fMRI measurements Receives: Drug: Nicotine gum |
| Old (60-85 years) participants - nicotine gum | Experimental | 6 mg nicotine gum, one time before fMRI measurements Receives: Drug: Nicotine gum |
| Young (18-28 years) participants - placebo gum | Placebo comparator | placebo gum, one time before fMRI measurements Receives: Other: Placebo gum |
| Old (60-85 years) participants - placebo gum | Placebo comparator | placebo gum, one time before fMRI measurements Receives: Other: Placebo gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
frequency tuning of excitatory auditory fMRI cortical responses
Functional magnetic resonance imaging (fMRI) responses to pure tone stimuli ranging from 88-8000 Hz will be recorded. For each voxel in objectively identified auditory cortical area, a tuning curve model will be fit to the data. One of the parameters of this model is the width of frequency tuning of excitatory responses, and this is the primary outcome measure.
Measured: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
Secondary outcomes (3)
frequency tuning of inhibitory auditory fMRI cortical responses
Functional magnetic resonance imaging (fMRI) responses to pure tone stimuli ranging from 88-8000 Hz will be recorded. For each voxel in objectively identified auditory cortical area, a tuning curve model will be fit to the data. One of the parameters of this model is the width of frequency tuning of inhibitory responses, and this is Outcome 2.
Measured: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
amplitude of excitatory auditory fMRI cortical responses
Functional magnetic resonance imaging (fMRI) responses to pure tone stimuli ranging from 88-8000 Hz will be recorded. For each voxel in objectively identified auditory cortical area, a tuning curve model will be fit to the data. One of the parameters of this model is the amplitude of excitatory responses, and this is Outcome 3.
Measured: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
amplitude of inhibitory auditory fMRI cortical responses
Functional magnetic resonance imaging (fMRI) responses to pure tone stimuli ranging from 88-8000 Hz will be recorded. For each voxel in objectively identified auditory cortical area, a tuning curve model will be fit to the data. One of the parameters of this model is the amplitude of inhibitory responses, and this is Outcome 4.
Measured: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2021
- Study start6 Jun 2022
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Nicotine (6 mg, polacrilex gum) and placebo will be administered to each participant in separate sessions in a within-subject double-blind randomized crossover design. Subjects will be in either a young (18-28 years) or old (60-85 years) group.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Michael A Silver, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05018117
- Sponsor's protocol ID
- 2018-12-11682
- Other IDs
- R01AG067073-01A1
- Status last verified
- Jul 2026
- First submitted
- 11 Aug 2021
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex
- ClinicalTrials.gov ID
- NCT05018117
- Acronym / sponsor ID
- 2018-12-11682
- Conditions
- Aging
- Keywords
- nicotine, acetylcholine, functional magnetic resonance imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 24 Aug 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.
Nicotine enhances auditory-cognitive function because it mimics the brain's system for "paying attention" to important sounds amid distractions (for example, understanding speech in a noisy environment). In part, nicotine does this by activating inhibitory neurons in the auditory cortex. Since age-related hearing deficits result, in part, from the loss of inhibitory neurons in auditory cortex, this project will determine whether nicotine's effects can compensate for reduced inhibition in the aging auditory cortex and thereby restore auditory function.
The investigators will use functional magnetic resonance imaging (fMRI) to measure the selectivity of responses in auditory cortex to tones of various frequencies. The investigators will measure the effects of nicotine (administered as chewing gum) and aging on these fMRI response properties. The investigators hypothesize that frequency selectivity will decrease with aging and increase following nicotine administration.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Nicotine (6 mg, polacrilex gum) and placebo will be administered to each participant in separate sessions in a within-subject double-blind randomized crossover design. Subjects will be in either a young (18-28 years) or old (60-85 years) group.
| Arm | Type | Receives |
|---|---|---|
| Young (18-28 years) participants - nicotine gum | Experimental | Drug: Nicotine gum6 mg nicotine gum, one time before fMRI measurements |
| Old (60-85 years) participants - nicotine gum | Experimental | Drug: Nicotine gum6 mg nicotine gum, one time before fMRI measurements |
| Young (18-28 years) participants - placebo gum | Placebo comparator | Other: Placebo gumplacebo gum, one time before fMRI measurements |
| Old (60-85 years) participants - placebo gum | Placebo comparator | Other: Placebo gumplacebo gum, one time before fMRI measurements |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
Key exclusion criteria (5 listed)
- 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
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 gumAlso: polacrilexThe effects of over-the-counter nicotine gum will be compared to a placebo gum | Drug | Old (60-85 years) participants - nicotine gum, Young (18-28 years) participants - nicotine gum |
| Placebo gumThe effects of over-the-counter nicotine gum will be compared to a placebo gum | Other | Old (60-85 years) participants - placebo gum, Young (18-28 years) participants - placebo gum |
Primary outcome
frequency tuning of excitatory auditory fMRI cortical responses
Time frame: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
Functional magnetic resonance imaging (fMRI) responses to pure tone stimuli ranging from 88-8000 Hz will be recorded. For each voxel in objectively identified auditory cortical area, a tuning curve model will be fit to the data. One of the parameters of this model is the width of frequency tuning of excitatory responses, and this is the primary outcome measure.
3 secondary outcomes
frequency tuning of inhibitory auditory fMRI cortical responses
Time frame: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
amplitude of excitatory auditory fMRI cortical responses
Time frame: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
amplitude of inhibitory auditory fMRI cortical responses
Time frame: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.
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 24 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Michael A Silver, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Nicotine gum in people with Aging, run by University of California, Berkeley 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 1 inclusion and 5 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 24 Jul 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
frequency tuning of excitatory auditory fMRI cortical responses (time frame: Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.). 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 24 Jul 2026.