Adverse Childhood Experiences in Substance-related Disorders

NCT03758053 | Unknown

• 1 other identifier: GRK2350-B5
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Alcohol Use Disorder; Trauma, Psychological

Outcome Measures

Primary Outcomes (3)

• 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)

• 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)

• 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 Outcomes (3)

• Hormonal stress response using salivary cortisol level

  Normal awakening response on a subject's regular week-day (0, 0.5, 8 and 14 hours after wake-up)

• Hormonal stress response using salivary cortisol level

  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)

• GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms

  blood sample at one day only (day of fMRI experiment)

Study Arms (3)

Individuals with alcohol use disorder + ACE

Individuals with AUD and varying levels of adverse childhood experiences (ACE)

Other: No intervention

Healthy controls

Healthy individuals without AUD

Other: No intervention

Individuals with alcohol use disorder, no ACE

Individuals with AUD and no adverse childhood experiences (ACE)

Other: No intervention

Interventions

No intervention OTHER

No intervention

Also known as: observational study

Healthy controls; Individuals with alcohol use disorder + ACE; Individuals with alcohol use disorder, no ACE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Residents from Mannheim/ Heidelberg who answered an open call to participate in this study

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• German Research Foundation: collaborator

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Location

Related Publications (1)

• 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.

  PMID: 36577733 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Saliva (stress hormones) Blood (genotyping)

MeSH Terms

Conditions

Alcoholism; Psychological Trauma

Interventions

Observation

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Sabine Vollstaedt-Klein

  CIMH Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: November 29, 2018
• Study Start: December 15, 2018
• Primary Completion: May 27, 2021
• Study Completion: August 31, 2021
• Last Updated: July 29, 2021

Record last verified: 2021-07

Locations

DE (1)