Adverse Childhood Experiences in Substance-related Disorders

Alcohol Use Disorder Clinical Trial

Official title:

Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03758053
• Other study ID #: GRK2350-B5
• Status: Active, not recruiting
• Start date: December 15, 2018
• Est. completion date: August 31, 2021

Study information

• Verified date: July 2021
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 70
• Est. completion date: August 31, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Psychological Trauma
• Substance-Related Disorders
• Trauma, Psychological

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	German Research Foundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity	Stress-sensitivity: stress task (e.g.mental rotation with and without time pressure) with social component within the MRI scanner to assess neural activation patters during the stress-task	fMRI measurement at one day only (day of fMRI experiment)
Primary	fMRI to assess group differences in task-specific brain activation patterns: Emotion processing	Emotion-processing: emotional face-/form-matching task to assess neural activation patters of emotion processing	fMRI measurement at one day only (day of fMRI experiment)
Primary	fMRI to assess group differences in task-specific brain activation patterns: Alcohol cue-reactivity	Alcohol cue-reactivity: pictures of alcoholic beverages to asses neural alcohol-cue reactivity	fMRI measurement at one day only (day of fMRI experiment)
Secondary	Hormonal stress response using salivary cortisol level	Collection of saliva on a subject's regular week-day for the individual's normal cortisol awakening response and circadian rhythm (basal hypothalamic-pituitary-adrenal-function at 0, 0.5, 8 and 14 hours after wake-up).; Cortisol awakening reaction, area under the curve and slope will therefore be calculated [nmol/L].	Normal awakening response on a subject's regular week-day (0, 0.5, 8 and 14 hours after wake-up)
Secondary	Hormonal stress response using salivary cortisol level	Collection of saliva during the course of the fMRI stress task for task-induced stress effects on salivary cortisol levels (at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction).; Cortisol: Area under the curve and slope will therefore be calculated [nmol/L].	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)
Secondary	GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms	Genomic DNA using 40ml EDTA-blood	blood sample at one day only (day of fMRI experiment)