Alcohol Use Disorder Clinical Trial
Official title:
Vulnerability for Alcohol Use Disorder After ACE: the Role of Stress Sensitivity, Emotion Processing, Cue Reactivity and Cognitive Functions in Relapse Risk
Verified date | March 2024 |
Source | Central Institute of Mental Health, Mannheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Adverse childhood experiences (ACE) and their relation to the development of an alcohol use disorder (AUD) will be measured with functional magnetic resonance imaging (fMRI).
Status | Completed |
Enrollment | 43 |
Est. completion date | January 17, 2024 |
Est. primary completion date | January 17, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - 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" - 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) and varying levels of adverse childhood experiences Exclusion Criteria: - Withdrawal of the declaration of consent - Exclusion criteria for an MRI scan (pregnancy, metal implants, etc.) - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit | Mannheim | Baden-Württemberg |
Lead Sponsor | Collaborator |
---|---|
Central Institute of Mental Health, Mannheim | German Research Foundation |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Stress-sensitivity | Stress-sensitivity: Imaging Stress Task to assess neural activation patterns during mental arithmetic tasks with negative feedback | fMRI measurement at one day only (day of fMRI experiment) | |
Primary | fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Emotion processing | Emotion-processing: emotional face-/form-matching task to assess neural activation patters of emotion processing | fMRI measurement at one day only (day of fMRI experiment) | |
Primary | fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Alcohol cue-reactivity | Alcohol cue-reactivity: pictures of alcoholic beverages to assess neural alcohol-cue reactivity | fMRI measurement at one day only (day of fMRI experiment) | |
Primary | fMRI to assess group differences in task-specific brain activation patterns: Response inhibition | Response inhibition: Stop Signal Task (variation of go/no-go) to assess response inhibition. | fMRI measurement at one day only (day of fMRI experiment) | |
Primary | fMRI to assess group differences in task-specific brain activation patterns: Working memory | Working memory: n-back task (continuous performance) to assess working memory function. | fMRI measurement at one day only (day of fMRI experiment) | |
Primary | Long-term alcohol consumption | Self-report in longitudinal sample measured with the LDH interview | 2 - 2.5 year follow-up after first project | |
Primary | Short-term alcohol consumption | Self-report in whole sample measured with the Form 90 interview | 3-month follow-up after current project | |
Secondary | Hormonal stress response using salivary cortisol level | Collection of saliva on a subject's regular week-day for the individual's normal cortisol awakening response and circadian rhythm (basal hypothalamic-pituitary-adrenal-function at 0, 0.5, 8 and 14 hours after wake-up).
Cortisol awakening reaction, area under the curve and slope will therefore be calculated [nmol/L] |
Normal awakening response on a subject's regular week-day (0, 0.5, 8 and 14 hours after wake-up) | |
Secondary | Hormonal stress response using salivary cortisol level | Time course of salivary cortisol level. Area under the curve and slope will be calculated [nmol/L] | day of fMRI experiment, at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction | |
Secondary | GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms | Genomic DNA using 40ml EDTA-blood | Blood sample at one day only (day of fMRI experiment) |
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