Adverse Childhood Experiences in Substance-related Disorders

NCT ID: NCT03758053

Last Updated: 2021-07-29

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

70 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-12-15

Study Completion Date

2021-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alcohol Use Disorder Trauma, Psychological

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

Intervention Type OTHER

No intervention

Healthy controls

Healthy individuals without AUD

No intervention

Intervention Type OTHER

No intervention

Individuals with alcohol use disorder, no ACE

Individuals with AUD and no adverse childhood experiences (ACE)

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

No intervention

Intervention Type OTHER

Other Intervention Names

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observational study

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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German Research Foundation

OTHER

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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Germany

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.

Reference Type DERIVED
PMID: 36577733 (View on PubMed)

Other Identifiers

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GRK2350-B5

Identifier Type: -

Identifier Source: org_study_id

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