Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, 68159, Germany
NCT Number: NCT05048758
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).
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Notify Me18 year–65 year
All sexes
Observational
Mannheim, Baden-Wurttemberg, 68159, Germany
The aim of this study is to examine the impact of ACE on stress sensitivity, cue-reactivity, and emotion processing in individuals with AUD at a longitudinal level. For this, participants (excluding healthy controls) from the first project (see https://clinicaltrials.gov/ct2/show/NCT03758053) will be re-examined after 2 to 2.5 years to explore the involvement of these mechanisms in relation to (long-term) relapse risk, which is a central issue in substance use disorders. Furthermore, we will investigate cognitive functions, specifically response inhibition and working memory, in the relationship between ACE and AUD. Additional participants may be recruited to mitigate sample attrition from the first project and to achieve the desired sample size. To assess cognitive functions and data from new participants in relation to relapse risk, we will perform a 3-month follow-up.
Neural correlates of stress-sensitivity, emotion processing, alcohol cue-reactivity and cognitive functions 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 current project is interested in the extent to which ACE severity modulates neural activation in specific brain regions during the execution of fMRI paradigms as well as alcohol-related measures (e.g., craving and alcohol consumption). Of particular interest is the question whether these neural and alcohol-related measures are associated with relapse risk.
55 individuals with AUD and varying levels of ACE will be examined using interviews, questionnaires, fMRI tasks as well as saliva and blood samples. Update from 29/03/2023: the relationships of interest will be examined using a dimensional approach to the predictor variable (ACE). Thus, participants will not be divided into two groups (no or mild ACE vs. moderate to severe ACE) as originally planned, but will instead be treated as one group with varying levels of ACE. The new sample size (n = 55) is based on an updated sample size calculation for a linear regression (two-tailed) using the following input parameters: f² = 0.15 (moderate effect size), alpha error = 0.05, and power = 80%. All ethical votes and informed consents of participants will be obtained according to the declaration of Helsinki.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
No intervention
Other names: Observational study
Time frame: fMRI measurement at one day only (day of fMRI experiment)
Stress-sensitivity: Imaging Stress Task to assess neural activation patterns during mental arithmetic tasks with negative feedback
Time frame: 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
Time frame: fMRI measurement at one day only (day of fMRI experiment)
Alcohol cue-reactivity: pictures of alcoholic beverages to assess neural alcohol-cue reactivity
Time frame: fMRI measurement at one day only (day of fMRI experiment)
Response inhibition: Stop Signal Task (variation of go/no-go) to assess response inhibition.
Time frame: fMRI measurement at one day only (day of fMRI experiment)
Working memory: n-back task (continuous performance) to assess working memory function.
Time frame: 2 - 2.5 year follow-up after first project
Self-report in longitudinal sample measured with the LDH interview
Time frame: 3-month follow-up after current project
Self-report in whole sample measured with the Form 90 interview
Time frame: Normal awakening response on a subject's regular week-day (0, 0.5, 8 and 14 hours after wake-up)
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]
Time frame: day of fMRI experiment, at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction
Time course of salivary cortisol level. Area under the curve and slope will be calculated [nmol/L]
Time frame: Blood sample at one day only (day of fMRI experiment)
Genomic DNA using 40ml EDTA-blood
Central Institute of Mental Health, Mannheim
Other
Vulnerability for Alcohol Use Disorder After ACE: the Role of Stress Sensitivity, Emotion Processing, Cue Reactivity and Cognitive Functions in Relapse Risk
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