Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity
研究概览
简要总结
Aversive childhood experiences (ACE) and their relation to the development of an alcohol use disorder will be measured with fMRI.
详细描述
The aim of this study is to examine the impact of ACE on stress sensitivity, cue-reactivity and emotion processing in individuals with AUD. (Neuro-) biological and physiological mechanisms underlying AUD after ACE will be studied.
Neural correlates of stress-sensitivity, emotion processing and alcohol cue-reactivity will be assessed using fMRI. Furthermore, blood and saliva samples will be used to assess biological and physiological mechanisms (e.g. salivary cortisol level or genetic markers of AUD and possible gene-environment-interactions).
The question whether individuals with AUD and ACE might tend to use alcohol to cope with stress, negative affect or intrusions (according to the self-medication model) will be explored. On the other hand, individuals with AUD and low levels of ACE might use alcohol for its positive effects (according to a positive reinforcement model).
90 individuals (30 HC and 60 individuals with AUD and varying levels of ACE) will be examined using interviews, questionnaires and fMRI tasks as well as saliva and blood samples. All ethical votes and informed consents of participants are and will be obtained according to the declaration of Helsinki.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 是
入选标准
- •male and female
- •age between 18 and 65
- •normal or correctable eyesight
- •Sufficient ability to communicate with the investigators, to answer questions in oral and written form
- •"Fully Informed Consent"
- •"Written Informed Consent"
- •Healthy individuals (AUDIT Score<=8, alcohol intake < 12g/ less than 5 days (women) & 24g/ less than 5 days (men)
- •Individuals with alcohol use disorder according to DSM-5 or 'heavy drinking' (alcohol intake > 40g/ more than 5 days (women) & 60g/ more than 5 days (men) with up to 28 days of abstinence AND aversive childhood experiences
排除标准
- •Withdrawal of the declaration of consent
- •Exclusion criteria for an MRI scan (pregnancy, metal implants,...)
- •severe internal, neurological and psychiatric comorbidities
- •Pharmacotherapy with psychoactive substances within the last 14 days (except treatment with SSRI/SNRIs for at least 28 days)
- •Axis-I disorder according to ICD-10 and DSM 5 (except tobacco and alcohol use disorder, substance abuse with less than 2(11) criteria according to DSM-5, mild depressive episode, adaptation disorder and specific phobia within the last 12 months)
- •positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
- •withdrawal symptoms (CIWA-R > 7)
- •intoxication at time of investigation (breathalyzer > 0.3‰)
- •suicidal tendency or potential danger for others
结局指标
主要结局
fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity
时间窗: fMRI measurement at one day only (day of fMRI experiment)
Stress-sensitivity: stress task (e.g.mental rotation with and without time pressure) with social component within the MRI scanner to assess neural activation patters during the stress-task
fMRI to assess group differences in task-specific brain activation patterns: Emotion processing
时间窗: fMRI measurement at one day only (day of fMRI experiment)
Emotion-processing: emotional face-/form-matching task to assess neural activation patters of emotion processing
fMRI to assess group differences in task-specific brain activation patterns: Alcohol cue-reactivity
时间窗: fMRI measurement at one day only (day of fMRI experiment)
Alcohol cue-reactivity: pictures of alcoholic beverages to asses neural alcohol-cue reactivity
次要结局
- Hormonal stress response using salivary cortisol level(Stress response during the fMRI stress task (day of fMRI experiment, at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction))
- GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms(blood sample at one day only (day of fMRI experiment))