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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Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany