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Adverse Childhood Experiences in Substance-related Disorders

C

Central Institute of Mental Health, Mannheim

Status

Unknown

Conditions

Trauma, Psychological
Alcohol Use Disorder

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT03758053
GRK2350-B5

Details and patient eligibility

About

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

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

70 participants in 3 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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