Adverse Childhood Experiences in Substance-related Disorders

Sponsor
Central Institute of Mental Health, Mannheim (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03758053
Collaborator
German Research Foundation (Other)
70
1
32.5
2.2

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • 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. (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.

Study Design

Study Type:
Observational
Actual Enrollment :
70 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders
Actual Study Start Date :
Dec 15, 2018
Actual Primary Completion Date :
May 27, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Individuals with alcohol use disorder + ACE

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

Other: No intervention
No intervention
Other Names:
  • observational study
  • Healthy controls

    Healthy individuals without AUD

    Other: No intervention
    No intervention
    Other Names:
  • observational study
  • Individuals with alcohol use disorder, no ACE

    Individuals with AUD and no adverse childhood experiences (ACE)

    Other: No intervention
    No intervention
    Other Names:
  • observational study
  • Outcome Measures

    Primary Outcome Measures

    1. fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity [fMRI measurement at one day only (day of fMRI experiment)]

      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

    2. fMRI to assess group differences in task-specific brain activation patterns: Emotion processing [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 differences in task-specific brain activation patterns: Alcohol cue-reactivity [fMRI measurement at one day only (day of fMRI experiment)]

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

    Secondary Outcome Measures

    1. 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)]

      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 [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)]

      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].

    3. GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms [blood sample at one day only (day of fMRI experiment)]

      Genomic DNA using 40ml EDTA-blood

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit Mannheim Germany

    Sponsors and Collaborators

    • Central Institute of Mental Health, Mannheim
    • German Research Foundation

    Investigators

    • Principal Investigator: Sabine Vollstaedt-Klein, CIMH Mannheim

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Central Institute of Mental Health, Mannheim
    ClinicalTrials.gov Identifier:
    NCT03758053
    Other Study ID Numbers:
    • GRK2350-B5
    First Posted:
    Nov 29, 2018
    Last Update Posted:
    Jul 29, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 29, 2021