Physiological, Neural and Behavioral Correlates of Psychosocial Stress and Alcohol Craving
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- change in blood pressure (systolic and diastolic)
研究概览
简要总结
In this feasibility study the investigators are using a setup of stress-related body sensors including established as well as innovative sensor-based measures to identify predictor profiles for alcohol-related behavioral and neural measures in Alcohol Use Disorder (AUD). Long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.
详细描述
The long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.
In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, the investigators aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity). In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the investigators will integrate innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Heavy drinking, defined by alcohol consumption of at least 20g alcohol per day (at 5 days per week)
- •sufficient ability to communicate with the investigators, to answer questions in oral and written form
- •fully informed consent
- •written informed consent
排除标准
- •withdrawal of the declaration of consent
- •positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
- •Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence.
- •Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
- •History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
- •Current use of medications or drugs known to interact with the CNS within at least four half-lives post last intake
结局指标
主要结局
change in blood pressure (systolic and diastolic)
时间窗: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at 2:20h, 2:50h, 3:20h, 3:50h, 4:50h, 5:05h after arrival of the proband
acquired with pressure sleeve
implicit alcohol association
时间窗: at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) \[reaction time differences is not a change over time; it is measured during one experimental session\]
neural alcohol-related cue-reactivity
时间窗: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
% signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010 \[% signal change is not a change over time; it is measured during one experimental session\]
neural inhibition processing
时间窗: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
% signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) \[% signal change is not a change over time; it is measured during one experimental session\]
change in heart rate
时间窗: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
heart rate acquired with ear clip (continuous time series)
change in heart rate variability
时间窗: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
heart rate variability acquired with ear clip (continuous time series)
change in electrodermal activity
时间窗: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband
time series acquired with body sensor
resting state activity
时间窗: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
resting state connectivity measured with fMRI
change in level of cortisol
时间窗: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
cortisol measured in saliva as a stress marker
neural emotion processing
时间窗: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
% signal change, measured with fMRI; faces task (Hariri et al. 2002) \[% signal change is not a change over time; it is measured during one experimental session\]
change in alcohol urges
时间窗: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
elf-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
attentional bias to alcohol cues
时间窗: at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) \[reaction time differences is not a change over time; it is measured during one experimental session\]
change in voice stress pattern
时间窗: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
audio file of participants' voice for voice stress pattern analysis will be recorded. From this a multivariate measure (i.e. multivariate vector) will be acquired (including frequency, loudness etc.)
change in alcohol craving
时间窗: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
次要结局
未报告次要终点