Adverse Childhood Experiences in Alcohol Use Disorder

NCT05048758 | Completed

• 1 other identifier: GRK2350-B5-P2
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

Adverse childhood experiences (ACE) and their relation to the development of an alcohol use disorder (AUD) will be measured with functional magnetic resonance imaging (fMRI).

Conditions

Alcohol Use Disorder; Trauma, Psychological

Outcome Measures

Primary Outcomes (7)

• fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Stress-sensitivity

  Stress-sensitivity: Imaging Stress Task to assess neural activation patterns during mental arithmetic tasks with negative feedback

  fMRI measurement at one day only (day of fMRI experiment)

• fMRI to assess group and within-subjects 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 and within-subjects differences in task-specific brain activation patterns: Alcohol cue-reactivity

  Alcohol cue-reactivity: pictures of alcoholic beverages to assess neural alcohol-cue reactivity

  fMRI measurement at one day only (day of fMRI experiment)

• fMRI to assess group differences in task-specific brain activation patterns: Response inhibition

  Response inhibition: Stop Signal Task (variation of go/no-go) to assess response inhibition.

  fMRI measurement at one day only (day of fMRI experiment)

• fMRI to assess group differences in task-specific brain activation patterns: Working memory

  Working memory: n-back task (continuous performance) to assess working memory function.

  fMRI measurement at one day only (day of fMRI experiment)

• Long-term alcohol consumption

  Self-report in longitudinal sample measured with the LDH interview

  2 - 2.5 year follow-up after first project

• Short-term alcohol consumption

  Self-report in whole sample measured with the Form 90 interview

  3-month follow-up after current project

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

  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 (1)

Individuals with AUD + varying levels of ACE

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

Other: No intervention

Interventions

No intervention OTHER

No intervention

Also known as: Observational study

Individuals with AUD + varying levels of ACE

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the Addiction Clinic at the Central Institute of Mental Health (Mannheim, Germany), as well as residents predominantly from the Mannheim/Heidelberg area 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"
• 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) and varying levels of adverse 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, Baden-Wurttemberg, 68159, Germany

Location

Related Publications (1)

• Turkmen C, Machunze N, Tan H, Gerhardt S, Kiefer F, Vollstadt-Klein S. Vulnerability for alcohol use disorder after adverse childhood experiences (AUDACE): protocol for a longitudinal fMRI study assessing neuropsychobiological risk factors for relapse. BMJ Open. 2022 Jun 30;12(6):e058645. doi: 10.1136/bmjopen-2021-058645.

  PMID: 35772833 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, PhD

  Central Institute of Mental Health, Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 8, 2021
• First Posted: September 17, 2021
• Study Start: November 22, 2021
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

DE (1)