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Adverse Childhood Experiences in Alcohol Use Disorder

Vulnerability for Alcohol Use Disorder After ACE: the Role of Stress Sensitivity, Emotion Processing, Cue Reactivity and Cognitive Functions in Relapse Risk

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05048758
Enrollment
43
Registered
2021-09-17
Start date
2021-11-22
Completion date
2024-01-17
Last updated
2024-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder, Trauma, Psychological

Brief summary

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).

Detailed description

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.

Interventions

OTHERNo intervention

No intervention

Sponsors

German Research Foundation
CollaboratorOTHER
Central Institute of Mental Health, Mannheim
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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 *

Design outcomes

Primary

MeasureTime frameDescription
Short-term alcohol consumption3-month follow-up after current projectSelf-report in whole sample measured with the Form 90 interview
fMRI to assess group differences in task-specific brain activation patterns: Working memoryfMRI measurement at one day only (day of fMRI experiment)Working memory: n-back task (continuous performance) to assess working memory function.
Long-term alcohol consumption2 - 2.5 year follow-up after first projectSelf-report in longitudinal sample measured with the LDH interview
fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Stress-sensitivityfMRI 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
fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Emotion processingfMRI 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 and within-subjects differences in task-specific brain activation patterns: Alcohol cue-reactivityfMRI measurement at one day only (day of fMRI experiment)Alcohol cue-reactivity: pictures of alcoholic beverages to assess neural alcohol-cue reactivity
fMRI to assess group differences in task-specific brain activation patterns: Response inhibitionfMRI measurement at one day only (day of fMRI experiment)Response inhibition: Stop Signal Task (variation of go/no-go) to assess response inhibition.

Secondary

MeasureTime frameDescription
GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphismsBlood sample at one day only (day of fMRI experiment)Genomic DNA using 40ml EDTA-blood
Hormonal stress response using salivary cortisol levelNormal 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 \[nmol/L\]

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026