Clinical trial NCT03758053: Adverse Childhood Experiences in Substance-related Disorders
Official title: Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alcohol Use Disorder
Trauma, Psychological
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: German Research Foundation
First posted: 2018-11-29
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Residents from Mannheim/ Heidelberg who answered an open call to participate in this study

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity
timeFrame: fMRI measurement at one day only (day of fMRI experiment)
measure: fMRI to assess group differences in task-specific brain activation patterns: Emotion processing
timeFrame: fMRI measurement at one day only (day of fMRI experiment)
measure: fMRI to assess group differences in task-specific brain activation patterns: Alcohol cue-reactivity
timeFrame: fMRI measurement at one day only (day of fMRI experiment)
Secondary outcomes:
measure: Hormonal stress response using salivary cortisol level
timeFrame: Normal awakening response on a subject's regular week-day (0, 0.5, 8 and 14 hours after wake-up)
measure: Hormonal stress response using salivary cortisol level
timeFrame: Stress response during the fMRI stress task (day of fMRI experiment, at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction)
measure: GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms
timeFrame: blood sample at one day only (day of fMRI experiment)
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Study officials:
affiliation: CIMH Mannheim
name: Sabine Vollstaedt-Klein
role: PRINCIPAL_INVESTIGATOR
References: