Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

University of California (UC), Berkeley

Status and phase: Enrolling; Early Phase 1

Conditions: Aging

Treatments: Drug: Nicotine gum; Other: Placebo gum

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05018117

2018-12-11682

R01AG067073-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Young (18-28 years) participants - nicotine gum

Experimental group

Description:

6 mg nicotine gum, one time before fMRI measurements

Treatment:

Drug: Nicotine gum

Old (60-85 years) participants - nicotine gum

Experimental group

Description:

6 mg nicotine gum, one time before fMRI measurements

Treatment:

Drug: Nicotine gum

Young (18-28 years) participants - placebo gum

Placebo Comparator group

Description:

placebo gum, one time before fMRI measurements

Treatment:

Other: Placebo gum

Old (60-85 years) participants - placebo gum

Placebo Comparator group

Description:

placebo gum, one time before fMRI measurements

Treatment:

Other: Placebo gum