Acute Nicotine Gum and Auditory Brain Responses in Adults With Chronic Tinnitus
A Randomized, Double-Blind, Placebo-Controlled, Within-Subject Crossover Trial of a Single 4 mg Dose of Nicotine Polacrilex Gum on Auditory Oddball P3, Oddball Task Performance, and Resting-State EEG in Non-Smoking Adults With Chronic Tinnitus
This study tests whether a single dose of nicotine gum changes brain responses to sounds and the ability to detect target sounds in non-smoking adults with chronic tinnitus. In a double-blind, placebo-controlled, within-subject crossover design, each participant attends two sessions and receives a single 4 mg dose of nicotine polacrilex gum at one session and a flavor-matched placebo gum at the other, in random order. After gum administration, EEG is recorded at rest and during an active auditory oddball task. The primary measures are the P3 brain response (amplitude and latency) and oddball task accuracy and reaction time.
연구 개요
상세 설명
Relationship to prior registration: This trial is a separate, newly enrolled study conducted under the same IRB-approved protocol (San Diego State University IRB-25-0430) as the completed trial NCT07772089, which evaluated acute nicotine gum effects on tinnitus loudness and selective attention. Participants and data in this trial are collected independently of NCT07772089.
Population: Non-smoking adults aged 18-80 years with chronic subjective tinnitus, using the same eligibility criteria as NCT07772089.
Intervention and administration: A single 4 mg dose of nicotine polacrilex gum or flavor-matched placebo gum, chewed continuously for 20 minutes at one chew per second (paced by a 1 Hz auditory cue) with saliva retained, following the administration protocol established in the investigators' gum optimization study.
Design: Randomized, double-blind, placebo-controlled, within-subject crossover with two sessions on separate days separated by a washout of at least 72 hours. Session order is randomized 1:1 using a computer-generated sequence; allocation is concealed with sequentially numbered, opaque, sealed envelopes; gum is prepared by an independent examiner and participants are blindfolded during administration.
Procedures: At the start of the first session, pure-tone audiometry, the Tinnitus Handicap Inventory, the Tinnitus Functional Index, and a pre-administration tinnitus loudness match are completed. In each session, tinnitus loudness is matched before and after gum administration. All EEG and oddball measures are obtained after gum administration only. EEG is analyzed at electrodes Fz, Cz, Pz, and Oz: resting-state spectral power (delta, theta, alpha, beta, gamma) and aperiodic (1/f) slope, and P3 amplitude and latency to target tones in an active auditory oddball task, with concurrent behavioral accuracy, reaction time, and d'.
연구 유형
등록 (추정된)
단계
- 2 단계
- 1단계
연락처 및 위치
연구 연락처
- 이름: Xianhui Wang
- 전화번호: 619-594-1151
- 이메일: kwang5@sdsu.edu
연구 장소
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California
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San Diego, California, 미국, 92182
- San Diego State University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Non-smoking adult, defined as fewer than 100 cigarettes in a lifetime and none in the past year, with a Fagerstrom Test for Nicotine Dependence score of 2 or less and a negative urinary cotinine test
- Chronic subjective tinnitus of at least 6 months' duration
Exclusion Criteria:
- Current or recent tobacco or nicotine use
- Pregnancy or breastfeeding
- Unstable cardiovascular disease
- Any condition precluding the psychoacoustic tasks
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Nicotine gum (4 mg)
Single 4 mg dose of nicotine polacrilex gum, chewed for 20 minutes at 1 Hz using the standardized administration protocol. |
A single 4 mg dose (one 4 mg piece) of mint nicotine polacrilex gum, chewed continuously for 20 minutes at one chew per second with saliva retained.
다른 이름들:
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위약 비교기: Placebo gum
Flavor-, color-, shape-, and texture-matched placebo gum, chewed under the identical protocol. |
Flavor-matched sugar-free mint gum (Trident) matched to the nicotine gum in shape, flavor, color, and texture, chewed under the identical protocol. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Auditory oddball P3 amplitude after administration (nicotine vs placebo)
기간: Up to 2 hours after gum administration
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P3 (P300) peak amplitude in microvolts was measured from the event-related potential elicited by target tones during an active auditory oddball task performed after gum administration, at electrodes Fz, Cz, Pz, and Oz. Amplitude was compared between the nicotine and placebo sessions. |
Up to 2 hours after gum administration
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Auditory oddball P3 latency after administration (nicotine vs placebo)
기간: Up to 2 hours after gum administration
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P3 (P300) peak latency in milliseconds was measured from the event-related potential elicited by target tones during an active auditory oddball task performed after gum administration, at electrodes Fz, Cz, Pz, and Oz. Latency was compared between the nicotine and placebo sessions. |
Up to 2 hours after gum administration
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Auditory oddball target-detection accuracy after administration (nicotine vs placebo)
기간: Up to 2 hours after gum administration
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Behavioral accuracy (percentage of target tones correctly detected) in the active auditory oddball task performed after gum administration was compared between the nicotine and placebo sessions. |
Up to 2 hours after gum administration
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Auditory oddball reaction time after administration (nicotine vs placebo)
기간: Up to 2 hours after gum administration
|
Mean reaction time in milliseconds to correctly detected target tones in the active auditory oddball task performed after gum administration was compared between the nicotine and placebo sessions. |
Up to 2 hours after gum administration
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Resting-state EEG spectral power and aperiodic (1/f) slope after administration (nicotine vs placebo)
기간: Up to 2 hours after gum administration
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Resting-state EEG was recorded after gum administration. Absolute spectral power was computed for the delta, theta, alpha, beta, and gamma frequency bands, and the aperiodic (1/f) slope of the power spectrum was estimated, at electrodes Fz, Cz, Pz, and Oz. Values were compared between the nicotine and placebo sessions. |
Up to 2 hours after gum administration
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Auditory oddball sensitivity (d') after administration (nicotine vs placebo)
기간: Up to 2 hours after gum administration
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Signal-detection sensitivity (d') computed from hits and false alarms in the active auditory oddball task performed after gum administration was compared between the nicotine and placebo sessions. |
Up to 2 hours after gum administration
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Within-session change in psychoacoustic tinnitus loudness match (nicotine vs placebo)
기간: Baseline (pre-administration) and up to 2 hours after gum administration
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Tinnitus loudness was matched to the participant's tinnitus pitch by a method-of-adjustment procedure and expressed in dB sensation level. The pre-to-post change was compared between the nicotine and placebo sessions. |
Baseline (pre-administration) and up to 2 hours after gum administration
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Tinnitus Handicap Inventory (THI) score
기간: Baseline (pre-administration, first session)
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The Tinnitus Handicap Inventory is a 25-item self-report questionnaire of tinnitus-related handicap. Each item is answered yes (4 points), sometimes (2 points), or no (0 points). The total score ranges from 0 to 100; higher scores indicate greater tinnitus handicap (a worse outcome). |
Baseline (pre-administration, first session)
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Tinnitus Functional Index (TFI) score
기간: Baseline (pre-administration, first session)
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The Tinnitus Functional Index is a 25-item self-report questionnaire of the functional impact of tinnitus. Each item is rated on a 0-10 scale, and the overall score is the mean of the answered items multiplied by 10. The overall score ranges from 0 to 100; higher scores indicate more severe tinnitus impact (a worse outcome). |
Baseline (pre-administration, first session)
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Pure-tone audiometry (0.25-12 kHz)
기간: Baseline (pre-administration, first session)
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Baseline hearing thresholds, collected once at the start of the first session. |
Baseline (pre-administration, first session)
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공동 작업자 및 조사자
수사관
- 수석 연구원: Xianhui Wang, San Diego State University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-25-0430-EEG
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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