Adverse Childhood Experiences in Substance-related Disorders

• Conditions: Alcohol Use Disorder; Trauma, Psychological
• Interventions: Other: No intervention

• Registration Number: NCT03758053
• Lead Sponsor: Central Institute of Mental Health, Mannheim

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.

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Study Start: 2018-12-15
• Primary Completion: 2021-05-27
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-28
• Last Update Posted: 2021-07-29
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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
• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	No intervention	Healthy individuals without AUD
Individuals with alcohol use disorder + ACE	No intervention	Individuals with AUD and varying levels of adverse childhood experiences (ACE)
Individuals with alcohol use disorder, no ACE	No intervention	Individuals with AUD and no adverse childhood experiences (ACE)

Primary Outcome Measures

Name	Time	Method
fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity	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	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	fMRI measurement at one day only (day of fMRI experiment)	Alcohol cue-reactivity: pictures of alcoholic beverages to asses neural alcohol-cue reactivity

Secondary Outcome Measures

Name	Time	Method
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)	Collection of saliva during the course of the fMRI stress task for task-induced stress effects on salivary cortisol levels (at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction).; Cortisol: Area under the curve and slope will therefore be calculated \[nmol/L\].
GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms	blood sample at one day only (day of fMRI experiment)	Genomic DNA using 40ml EDTA-blood

Trial Locations

Locations (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit; 🇩🇪 Mannheim, Germany