Using Nicotine to Reverse Age-related Auditory Processing Deficits
- Conditions
- Auditory Perceptual ImpairmentAging
- Interventions
- Other: Placebo gumOther: Nicotine gum
- Registration Number
- NCT04971954
- Lead Sponsor
- 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 48
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Placebo gum Placebo gum The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture. Nicotine gum Nicotine gum Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
- Primary Outcome Measures
Name Time Method Hearing thresholds 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.
Envelope following responses 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.
Modulation detection 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)).
- Secondary Outcome Measures
Name Time Method Heart rate 10 minutes Pulse rate in pulses per minute will be measured via pulse oximetry.
Nicotine side effects 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).
Mood change 10 minutes Mood change will be measured by a 9-category rating scale including: energy, contentedness, focus, relaxation, calmness, alertness, hunger etc.
Trial Locations
- Locations (1)
Hearing and Speech Lab
🇺🇸Irvine, California, United States