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Adverse Childhood Experiences in Substance-related Disorders

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ClinicalTrials.gov Identifier: NCT03758053
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : January 17, 2019
Sponsor:
Collaborator:
German Research Foundation
Information provided by (Responsible Party):
Central Institute of Mental Health, Mannheim

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
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. (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.


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Study Type : Observational
Estimated Enrollment : 90 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 : December 15, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drug Abuse

Group/Cohort 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 Name: observational study

Healthy controls
Healthy individuals without AUD
Other: No intervention
No intervention
Other Name: observational study

Individuals with alcohol use disorder, no ACE
Individuals with AUD and no adverse childhood experiences (ACE)
Other: No intervention
No intervention
Other Name: observational study




Primary Outcome Measures :
  1. fMRI to assess group differences in task-specific brain activation patterns: Stress-sensitivity [ Time Frame: 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 [ 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 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 asses neural alcohol-cue reactivity


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: 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 [ 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)


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Residents from Mannheim/ Heidelberg 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"
  • 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

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): NCT03758053


Contacts
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Contact: Sabine Vollstaedt-Klein 0621 / 1703 - 3912 Sabine.Vollstaedt-Klein@zi-mannheim.de

Locations
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Germany
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit Recruiting
Mannheim, Germany
Contact: Sabine Vollstädt-Klein         
Sponsors and Collaborators
Central Institute of Mental Health, Mannheim
German Research Foundation
Investigators
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Principal Investigator: Sabine Vollstaedt-Klein CIMH Mannheim

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Responsible Party: Central Institute of Mental Health, Mannheim
ClinicalTrials.gov Identifier: NCT03758053     History of Changes
Other Study ID Numbers: GRK2350-B5
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

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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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Disease
Alcoholism
Substance-Related Disorders
Psychological Trauma
Pathologic Processes
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders