Using Nicotine to Reverse Age-related Auditory Processing Deficits

Aging Clinical Trial

— Nicotine  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04971954
• Other study ID #: HS#2013-9964
• Secondary ID: 1R01AG067073
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: May 2023
• Source: University of California, Irvine
• Contact: Michelle Kapolowicz, PhD
• Phone: 9498249107
• Email: mkapolow[@]hs.uci.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 30, 2026
• Est. primary completion date: January 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

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

Locations

Country	Name	City	State
United States	Hearing and Speech Lab	Irvine	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Heatherton TF, Kozlowski LT, Frecker RC, Fagerstrom KO. The Fagerstrom Test for Nicotine Dependence: a revision of the Fagerstrom Tolerance Questionnaire. Br J Addict. 1991 Sep;86(9):1119-27. doi: 10.1111/j.1360-0443.1991.tb01879.x. — View Citation

Morris JC, Heyman A, Mohs RC, Hughes JP, van Belle G, Fillenbaum G, Mellits ED, Clark C. The Consortium to Establish a Registry for Alzheimer's Disease (CERAD). Part I. Clinical and neuropsychological assessment of Alzheimer's disease. Neurology. 1989 Sep;39(9):1159-65. doi: 10.1212/wnl.39.9.1159. — View Citation

Pham CQ, Kapolowicz MR, Metherate R, Zeng FG. Nicotine enhances auditory processing in healthy and normal-hearing young adult nonsmokers. Psychopharmacology (Berl). 2020 Mar;237(3):833-840. doi: 10.1007/s00213-019-05421-x. Epub 2019 Dec 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cognition	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.	1 hour
Primary	Hearing thresholds	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.	1 hour
Primary	Modulation detection	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)).	1 hour
Primary	Envelope following responses	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.	2 hours
Secondary	Heart rate	Pulse rate in pulses per minute will be measured via pulse oximetry.	10 minutes
Secondary	Mood change	Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.	10 minutes
Secondary	Nicotine side effects	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).	10 minutes