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临床试验/NCT05369169
NCT05369169已完成不适用

Afferent Neurocardiac Signals, Cue Reactivity, and Cognitive Control

Rutgers, The State University of New Jersey1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
P3b ERP amplitude (in microvolts) elicited from a picture-viewing task

研究概览

简要总结

Conscious attempts to regulate alcohol use are often undermined by automatic attention and arousal processes activated by alcohol cues, as well as by diminished ability to inhibit in-the-moment behaviors. The current study will examine whether a brief behavioral intervention of slow breathing paced at a resonance frequency of the cardiovascular system can interrupt automatic alcohol cue reactivity and enhance cognitive control in binge drinkers. Results from the proposed study may provide new prevention and intervention targets to interrupt unhealthy drinking behaviors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Must report at least 2 binge drinking episodes in the past month
  • Have normal or corrected-to-normal vision

排除标准

  • History or presence of serious psychiatric disorders, neurological disorders, or head injury resulting in a loss of consciousness
  • Presence of any serious medical condition
  • Report of more than a few occasions (3-4) of illicit drug use, except for cannabis, in the preceding year

研究组 & 干预措施

Resonance paced breathing

Experimental

Active resonance breathing task consisting of synchronizing breathing with a visual pacer (E-Z Air, Thought Technology, Ltd., Plattsburgh, NY) that moves up (inhale) and down (exhale) at the rate of 0.1 Hz (6 breaths per min)

干预措施: Resonance breathing (Behavioral)

Low demand vanilla control

Active Comparator

A low-demand cognitive "vanilla" task wherein different colored rectangles are presented for 10 sec each, and participants are instructed to silently count the number of blue rectangles

干预措施: Low demand cognitive task (Behavioral)

结局指标

主要结局

P3b ERP amplitude (in microvolts) elicited from a picture-viewing task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

The P3b component of the event-related potential occurring 300-600 ms after stimulus presentation at central and parietal electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task

N2 ERP amplitude (in microvolts) elicited from an Alcohol Cued Go/No-Go task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

The N2 component (in microvolts) of the event-related potential occurring 250-350 ms after stimulus presentation at frontal and central electrode sites during an Alcohol Cued Go/No-Go task following a 5-minute course of resonance breathing compared to a low-demand control task

N2pc ERP amplitude (in microvolts) elicited from a visual dot probe detection task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

The N2pc component of the event-related potential occurring 200-275 ms after stimulus presentation at parietal and occipital electrode sites (ipsilateral minus contralateral hemisphere activity) during a modified visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task

N2 ERP latency (in milliseconds) elicited from an Alcohol Cued Go/No-Go task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

The latency of the N2 component of the event-related potential from frontal and central electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions

N2pc ERP latency (in milliseconds) elicited from a visual dot probe detection task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

The latency of the N2pc component of the event-related potential from parietal and occipital electrode sites during a visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions

P3b ERP latency (in milliseconds) elicited from a picture-viewing task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

The latency of the P3b component of the event-related potential from central and parietal electrode sites during a picture viewing task following a 5-minute course of resonance breathing compared to a low-demand control task. Latency will be determined using 50% area latency from a difference wave between task conditions

Task accuracy from the behavioral response during the Alcohol Cued Go/No-Go task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

Task accuracy as a percentage of correct behavioral responses to the task during the Alcohol Cued Go/No-Go ERP task following a 5-minute course of resonance breathing compared to a low-demand control task

Reaction time from the behavioral response during the Alcohol Cued Go/No-Go task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

Reaction time for the correct behavioral responses to the task measured in milliseconds during the Alcohol Cued Go/No-Go ERP task following a 5-minute course of resonance breathing compared to a low-demand control task

Task accuracy from the behavioral response during the visual dot probe detection task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

Task accuracy as a percentage of correct behavioral responses to the task during the visual dot probe detection task following a 5-minute course of resonance breathing compared to a low-demand control task

Reaction time from the behavioral response during the visual dot probe detection task

时间窗: Immediate; Difference between the active resonance breathing compared to the low demand cognitive task occurring one week apart

Reaction time for the correct behavioral responses to the task measured in milliseconds during the visual dot probe ERP task following a 5-minute course of resonance breathing compared to a low-demand control task

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Brandon Alderman, Ph.D.

Associate Professor and Chair

Rutgers, The State University of New Jersey

研究点 (1)

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