Stress-related Predictor Profiles for Craving and Relapse in Human Addiction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- resting state activity
研究概览
简要总结
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. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on measures relevant for the development and maintenance of Alcohol Use Disorder (AUD). Further, we aim to identify neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers, we will integrate innovative sensor-based measures.
详细描述
In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on (1) alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity), (2) their predictive capacity for future alcohol intake, (3) the identification their neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), (4) we will integrate portable sensors (wearables) to allow a future integration in ambulatory assessments and to test innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance. Our 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.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Alcohol-use disorder according to 2 DSM-V criteria not requiring detoxification: AUD subjects with mild AUD will fulfill at least 2 and not more than 5 diagnostic criteria; a second group of AUD subjects will fulfill 4-5 criteria for moderate AUD
- •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
- •Pregnancy
- •Using hormonal contraceptives
- •Perimenopausal/ postmenopausal
- •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
研究组 & 干预措施
Control
Participants reads newspaper before Barlab-Exposure
干预措施: Barlab-Exposure (Behavioral)
Control
Participants reads newspaper before Barlab-Exposure
干预措施: Reading Newspaper (Behavioral)
Experimental 1 (Distress)
Participants undergo the Trier Social Stress Test before Barlab-Exposure
干预措施: Trier Social Stress Test (Behavioral)
Experimental 1 (Distress)
Participants undergo the Trier Social Stress Test before Barlab-Exposure
干预措施: Barlab-Exposure (Behavioral)
Experimental 2 (Eustress)
Participants ride an ergometer before Barlab-Exposure
干预措施: Ergometer (Behavioral)
Experimental 2 (Eustress)
Participants ride an ergometer before Barlab-Exposure
干预措施: Barlab-Exposure (Behavioral)
结局指标
主要结局
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
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 blood pressure (systolic and diastolic)
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
acquired with pressure sleeve
fMRI
时间窗: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
neural alcohol-related cue-reactivity, stop-signal reaction time task, emotion processing and resting state 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
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 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 hour; 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
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
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) \[% signal change is not a change over time; it is measured during one experimental session\]
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) \[% signal change is not a change over time; it is measured during one experimental session\]
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) \[reaction time differences is not a change over time; it is measured during one experimental session\]
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
self-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
次要结局
- alcohol consumption(12 months follow-up)