Adverse Childhood Experiences in Substance-related Disorders
NCT ID: NCT03758053
Last Updated: 2021-07-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
70 participants
OBSERVATIONAL
2018-12-15
2021-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Individuals with alcohol use disorder + ACE
Individuals with AUD and varying levels of adverse childhood experiences (ACE)
No intervention
No intervention
Healthy controls
Healthy individuals without AUD
No intervention
No intervention
Individuals with alcohol use disorder, no ACE
Individuals with AUD and no adverse childhood experiences (ACE)
No intervention
No intervention
Interventions
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No intervention
No intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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German Research Foundation
OTHER
Central Institute of Mental Health, Mannheim
OTHER
Responsible Party
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Principal Investigators
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Sabine Vollstaedt-Klein
Role: PRINCIPAL_INVESTIGATOR
CIMH Mannheim
Locations
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Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, , Germany
Countries
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References
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Gerhardt S, Berhe O, Moessnang C, Horning M, Kiefer F, Tost H, Vollstadt-Klein S. Lack of amygdala habituation to negative emotional faces in alcohol use disorder and the relation to adverse childhood experiences. Addict Biol. 2023 Jan;28(1):e13251. doi: 10.1111/adb.13251.
Other Identifiers
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GRK2350-B5
Identifier Type: -
Identifier Source: org_study_id
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