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Adverse Childhood Experiences in Substance-related Disorders

Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03758053
Enrollment
70
Registered
2018-11-29
Start date
2018-12-15
Completion date
2021-08-31
Last updated
2021-07-29

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

Aversive childhood experiences (ACE) and their relation to the development of an alcohol use disorder will be measured with 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. (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.

Interventions

OTHERNo intervention

No intervention

Sponsors

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

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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 * 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

Exclusion criteria

* Withdrawal of the declaration of consent *

Design outcomes

Primary

MeasureTime frameDescription
fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivityfMRI 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 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 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 asses neural alcohol-cue reactivity

Secondary

MeasureTime frameDescription
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 \[nmol/L\].
GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphismsblood sample at one day only (day of fMRI experiment)Genomic DNA using 40ml EDTA-blood

Countries

Germany

Outcome results

None listed

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