Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

Aging Clinical Trial

Official title:

Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018117
• Other study ID #: 2018-12-11682
• Secondary ID: R01AG067073-01A1
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 6, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: April 2024
• Source: University of California, Berkeley
• Contact: Michael A Silver, PhD
• Phone: 5106423130
• Email: masilver[@]berkeley.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Aging

Intervention

Drug:
• Nicotine gum
The effects of over-the-counter nicotine gum will be compared to a placebo gum

Other:
• Placebo gum
The effects of over-the-counter nicotine gum will be compared to a placebo gum

Locations

Country	Name	City	State
United States	University of California, Berkeley	Berkeley	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Berkeley	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	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	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.	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	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.	Functional MRI recordings will begin approximately 30 minutes after oral administration of polacrilex or placebo gum and will continue for up to two hours.