Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

NCT ID: NCT05018117

Last Updated: 2024-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-06

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Young (18-28 years) participants - nicotine gum

6 mg nicotine gum, one time before fMRI measurements

Group Type EXPERIMENTAL

Nicotine gum

Intervention Type DRUG

The effects of over-the-counter nicotine gum will be compared to a placebo gum

Old (60-85 years) participants - nicotine gum

6 mg nicotine gum, one time before fMRI measurements

Group Type EXPERIMENTAL

Nicotine gum

Intervention Type DRUG

The effects of over-the-counter nicotine gum will be compared to a placebo gum

Young (18-28 years) participants - placebo gum

placebo gum, one time before fMRI measurements

Group Type PLACEBO_COMPARATOR

Placebo gum

Intervention Type OTHER

The effects of over-the-counter nicotine gum will be compared to a placebo gum

Old (60-85 years) participants - placebo gum

placebo gum, one time before fMRI measurements

Group Type PLACEBO_COMPARATOR

Placebo gum

Intervention Type OTHER

The effects of over-the-counter nicotine gum will be compared to a placebo gum

Interventions

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Nicotine gum

The effects of over-the-counter nicotine gum will be compared to a placebo gum

Intervention Type DRUG

Placebo gum

The effects of over-the-counter nicotine gum will be compared to a placebo gum

Intervention Type OTHER

Other Intervention Names

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polacrilex

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, Berkeley

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael A Silver, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, Berkeley

Locations

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University of California, Berkeley

Berkeley, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael A Silver, PhD

Role: CONTACT

5106423130

Facility Contacts

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Michael A Silver, PhD

Role: primary

510-642-3130

Other Identifiers

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R01AG067073-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-12-11682

Identifier Type: -

Identifier Source: org_study_id

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