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Adverse Childhood Experiences in Alcohol Use Disorder

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ClinicalTrials.gov Identifier: NCT05048758
Recruitment Status : Completed
First Posted : September 17, 2021
Last Update Posted : March 29, 2024
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

Study Description
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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).

Condition or disease Intervention/treatment
Alcohol Use Disorder Trauma, Psychological Other: No intervention

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 at a longitudinal level. For this, participants (excluding healthy controls) from the first project (see https://clinicaltrials.gov/ct2/show/NCT03758053) will be re-examined after 2 to 2.5 years to explore the involvement of these mechanisms in relation to (long-term) relapse risk, which is a central issue in substance use disorders. Furthermore, we will investigate cognitive functions, specifically response inhibition and working memory, in the relationship between ACE and AUD. Additional participants may be recruited to mitigate sample attrition from the first project and to achieve the desired sample size. To assess cognitive functions and data from new participants in relation to relapse risk, we will perform a 3-month follow-up.

Neural correlates of stress-sensitivity, emotion processing, alcohol cue-reactivity and cognitive functions 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 current project is interested in the extent to which ACE severity modulates neural activation in specific brain regions during the execution of fMRI paradigms as well as alcohol-related measures (e.g., craving and alcohol consumption). Of particular interest is the question whether these neural and alcohol-related measures are associated with relapse risk.

55 individuals with AUD and varying levels of ACE will be examined using interviews, questionnaires, fMRI tasks as well as saliva and blood samples. Update from 29/03/2023: the relationships of interest will be examined using a dimensional approach to the predictor variable (ACE). Thus, participants will not be divided into two groups (no or mild ACE vs. moderate to severe ACE) as originally planned, but will instead be treated as one group with varying levels of ACE. The new sample size (n = 55) is based on an updated sample size calculation for a linear regression (two-tailed) using the following input parameters: f² = 0.15 (moderate effect size), alpha error = 0.05, and power = 80%. All ethical votes and informed consents of participants will be obtained according to the declaration of Helsinki.

Study Design
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Study Type : Observational
Actual Enrollment : 43 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Vulnerability for Alcohol Use Disorder After ACE: the Role of Stress Sensitivity, Emotion Processing, Cue Reactivity and Cognitive Functions in Relapse Risk
Actual Study Start Date : November 22, 2021
Actual Primary Completion Date : January 17, 2024
Actual Study Completion Date : January 17, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol

Groups and Cohorts
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Group/Cohort Intervention/treatment
Individuals with AUD + varying levels of ACE
Individuals with alcohol use disorder (AUD) and varying levels of adverse childhood experiences (ACE)
 Other: No intervention
No intervention
Other Name: Observational study


Outcome Measures
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Primary Outcome Measures :
  1. fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Stress-sensitivity [ Time Frame: fMRI measurement at one day only (day of fMRI experiment) ]
    Stress-sensitivity: Imaging Stress Task to assess neural activation patterns during mental arithmetic tasks with negative feedback

  2. fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Emotion processing [ Time Frame: fMRI measurement at one day only (day of fMRI experiment) ]
    Emotion-processing: emotional face-/form-matching task to assess neural activation patters of emotion processing

  3. fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Alcohol cue-reactivity [ Time Frame: fMRI measurement at one day only (day of fMRI experiment) ]
    Alcohol cue-reactivity: pictures of alcoholic beverages to assess neural alcohol-cue reactivity

  4. fMRI to assess group differences in task-specific brain activation patterns: Response inhibition [ Time Frame: fMRI measurement at one day only (day of fMRI experiment) ]
    Response inhibition: Stop Signal Task (variation of go/no-go) to assess response inhibition.

  5. fMRI to assess group differences in task-specific brain activation patterns: Working memory [ Time Frame: fMRI measurement at one day only (day of fMRI experiment) ]
    Working memory: n-back task (continuous performance) to assess working memory function.

  6. Long-term alcohol consumption [ Time Frame: 2 - 2.5 year follow-up after first project ]
    Self-report in longitudinal sample measured with the LDH interview

  7. Short-term alcohol consumption [ Time Frame: 3-month follow-up after current project ]
    Self-report in whole sample measured with the Form 90 interview


Secondary Outcome Measures :
  1. Hormonal stress response using salivary cortisol level [ Time Frame: Normal awakening response on a subject's regular week-day (0, 0.5, 8 and 14 hours after wake-up) ]

    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]


  2. Hormonal stress response using salivary cortisol level [ Time Frame: day of fMRI experiment, at -45, -22, -10 minutes before and 35, 45, 60, 75 and 90 minutes after onset of stress induction ]
    Time course of salivary cortisol level. Area under the curve and slope will be calculated [nmol/L]

  3. GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms [ Time Frame: Blood sample at one day only (day of fMRI experiment) ]
    Genomic DNA using 40ml EDTA-blood


Biospecimen Retention:   Samples With DNA
Saliva (stress hormones) Blood (genotyping)

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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"
  • 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

Exclusion Criteria:

  • Withdrawal of the declaration of consent
  • Exclusion criteria for an MRI scan (pregnancy, metal implants, etc.)
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048758


Locations
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Germany
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Württemberg, Germany, 68159
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Research Foundation
Investigators
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Principal Investigator: Sabine Vollstaedt-Klein, PhD Central Institute of Mental Health, Mannheim
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT05048758    
Other Study ID Numbers: GRK2350-B5-P2
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: March 29, 2024
Last Verified: March 2024

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Alcohol Drinking
Psychological Trauma
Drinking Behavior
Alcohol-Related Disorders
 Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders