Status:
UNKNOWN
Adverse Childhood Experiences in Substance-related Disorders
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborating Sponsors:
German Research Foundation
Conditions:
Alcohol Use Disorder
Trauma, Psychological
Eligibility:
All Genders
18-65 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 15 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 31 2021
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT03758053
Start Date
December 15 2018
End Date
August 31 2021
Last Update
July 29 2021
Active Locations (1)
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1
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Germany