Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex

Sponsor
University of California, Berkeley (Other)
Overall Status
Recruiting
CT.gov ID
NCT05018117
Collaborator
National Institute on Aging (NIA) (NIH)
48
1
4
42.8
1.1

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nicotine gum
  • Other: Placebo gum
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
48 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention 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.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 (Participant, Investigator, Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Effects of Nicotine and Attention on Frequency Tuning in Auditory Cortex
Actual Study Start Date :
Jun 6, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Young (18-28 years) participants - nicotine gum

6 mg nicotine gum, one time before fMRI measurements

Drug: Nicotine gum
The effects of over-the-counter nicotine gum will be compared to a placebo gum
Other Names:
  • polacrilex
  • Experimental: Old (60-85 years) participants - nicotine gum

    6 mg nicotine gum, one time before fMRI measurements

    Drug: Nicotine gum
    The effects of over-the-counter nicotine gum will be compared to a placebo gum
    Other Names:
  • polacrilex
  • Placebo Comparator: Young (18-28 years) participants - placebo gum

    placebo gum, one time before fMRI measurements

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

    Placebo Comparator: Old (60-85 years) participants - placebo gum

    placebo gum, one time before fMRI measurements

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

    Outcome Measures

    Primary Outcome Measures

    1. frequency tuning of excitatory auditory fMRI cortical responses [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.

    Secondary Outcome Measures

    1. frequency tuning of inhibitory auditory fMRI cortical responses [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 inhibitory responses, and this is Outcome 2.

    2. amplitude of excitatory auditory fMRI cortical responses [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 amplitude of excitatory responses, and this is Outcome 3.

    3. amplitude of inhibitory auditory fMRI cortical responses [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 amplitude of inhibitory responses, and this is Outcome 4.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California, Berkeley Berkeley California United States 94720

    Sponsors and Collaborators

    • University of California, Berkeley
    • National Institute on Aging (NIA)

    Investigators

    • Principal Investigator: Michael A Silver, PhD, University of California, Berkeley

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of California, Berkeley
    ClinicalTrials.gov Identifier:
    NCT05018117
    Other Study ID Numbers:
    • 2018-12-11682
    • R01AG067073-01A1
    First Posted:
    Aug 24, 2021
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by University of California, Berkeley
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2022