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Using Nicotine to Reverse Age-related Auditory Processing Deficits (Nicotine)

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ClinicalTrials.gov Identifier: NCT04971954
Recruitment Status : Recruiting
First Posted : July 22, 2021
Last Update Posted : February 15, 2022
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Fan-Gang Zeng, University of California, Irvine

Brief Summary:
The present study will evaluate the effects of both aging and nicotine on psychophysical tasks and electrophysiological measures. Nicotine will be administered to study participants in the form of gum that is available as an over-the-counter medication. The hypothesis is that nicotine will reverse the detrimental effects of aging on auditory processing. The proposed experiments will characterize the effects of nicotine and may eventually lead to improved treatments of hearing loss in a variety of patient populations and in healthy aging.

Condition or disease Intervention/treatment Phase
Auditory Perceptual Impairment Aging Other: Nicotine gum Other: Placebo gum Not Applicable

Detailed Description:
Study participants will be recruited in two age groups: young (18-28 years) and old (60-85). Each participant will participate in two psychophysical and electrophysiological test sessions. For each of the two sessions, the participant will be administered gum before the test. For one of these sessions, the gum will be polacrilex that contains 6-mg nicotine, and for the other session, the gum will be a placebo control. The study will be double-blind, meaning that neither the experimenter nor the participant will know whether the participant has received nicotine or placebo for a given session. The study has a cross-over design, meaning that all participants will receive both nicotine and placebo in separate sessions. Finally, the order of drug administration will be counterbalanced, meaning that equal numbers of participants will receive 1) nicotine in session one and placebo in session two, and 2) placebo in session one and nicotine in session two.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: The nicotine and placebo gums will be administered in randomized, double-blind, counterbalanced fashion.
Masking: Double (Participant, Investigator)
Masking Description: Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication. The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
Primary Purpose: Basic Science
Official Title: Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology
Actual Study Start Date : February 1, 2022
Estimated Primary Completion Date : January 31, 2026
Estimated Study Completion Date : June 30, 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Nicotine gum
Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
Other: Nicotine gum
Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Placebo Comparator: Placebo gum
The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
Other: Placebo gum
The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.




Primary Outcome Measures :
  1. Hearing thresholds [ Time Frame: 1 hour ]
    Hearing thresholds in dB SPL will be measured as a function of sound frequency from 125 Hz to 8000 Hz in quiet or in noise.

  2. Modulation detection [ Time Frame: 1 hour ]
    Amplitude-modulated sounds will be presented at 70 dB SPL or a comfortable level. The detection threshold in percent modulation depth (m= 0 to 100) will be recorded and converted into signal-to-noise ratios in dB (=20log(m)).

  3. Envelope following responses [ Time Frame: 2 hours ]
    Electrophysiological responses will be recorded in response to amplitude or frequency-modulated sounds. The sounds will be presented at 70 dB SPL or a comfortable level. The EEG signal strength that is in synchrony with the modulation frequency in micro-Volts will be recorded.


Secondary Outcome Measures :
  1. Heart rate [ Time Frame: 10 minutes ]
    Pulse rate in pulses per minute will be measured via pulse oximetry.

  2. Mood change [ Time Frame: 10 minutes ]
    Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.

  3. Nicotine side effects [ Time Frame: 10 minutes ]
    Side effects will be rated on a 5-point scale including: 1 = none (no symptoms at all); 2 = mild (slight jitters); 3 = moderate (jittery, slight dull headache); 4 = moderately severe (jittery, dull headache, mild nausea); 5 = severe (jittery, dull or pounding headache, nausea, vomiting).


Other Outcome Measures:
  1. Cognition [ Time Frame: 1 hour ]
    Word learning, recall and animal fluency tests from the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) will be measured and normalized to the national standard distribution, with a score of 0 equaling to the mean and 1 being one standard deviation above the mean performance.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • between 18 and 85 years of age
  • non-smokers with a score of 0-2 out of 10 maximum on the Fagerström index of smoking dependency
  • cognitive performance within two standard deviations of the CERAD mean

Exclusion Criteria:

  • less than 18 or greater than 85 years of age
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04971954


Contacts
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Contact: Michelle Kapolowicz, PhD 9498249107 mkapolow@hs.uci.edu

Locations
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United States, California
Hearing and Speech Lab Recruiting
Irvine, California, United States, 92697
Contact: Michelle Kapolowicz, PhD    949-824-9107    mkapolow@hs.uci.edu   
Sponsors and Collaborators
University of California, Irvine
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Fan-Gang Zeng, PhD University of California, Irvine
Publications:
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Responsible Party: Fan-Gang Zeng, Professor, University of California, Irvine
ClinicalTrials.gov Identifier: NCT04971954    
Other Study ID Numbers: HS#2013-9964
1R01AG067073 ( U.S. NIH Grant/Contract )
First Posted: July 22, 2021    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Fan-Gang Zeng, University of California, Irvine:
nicotine
biomarker
Additional relevant MeSH terms:
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Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action