Using Nicotine to Reverse Age-related Auditory Processing Deficits

Brief Title

Using Nicotine to Reverse Age-related Auditory Processing Deficits

Official Title

Using Nicotine to Reverse Age-related Auditory Processing Deficits: Human Psychophysics and Electrophysiology

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.
    

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.
    


Study Type

Interventional


Primary Outcome

Hearing thresholds

Secondary Outcome

 Heart rate

Condition

Auditory Perceptual Impairment

Intervention

Nicotine gum

Study Arms / Comparison Groups

 Nicotine gum
Description:  Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

48

Start Date

August 1, 2021

Completion Date

June 30, 2026

Primary Completion Date

January 31, 2026

Eligibility 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
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Fan-Gang Zeng, PhD, 9498249107, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04971954

Organization ID

HS#2013-9964

Secondary IDs

1R01AG067073

Responsible Party

Principal Investigator

Study Sponsor

University of California, Irvine

Collaborators

 National Institute on Aging (NIA)

Study Sponsor

Fan-Gang Zeng, PhD, Principal Investigator, University of California, Irvine


Verification Date

July 2021