Alcohol Use DisorderNCT03758053
Adverse Childhood Experiences in Substance-related Disorders
An observational study of Alcohol Use Disorder and Trauma, Psychological, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
Trial summary
Aversive childhood experiences (ACE) and their relation to the development of an alcohol use disorder will be measured with fMRI. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, Trauma, Psychological
- How many people
- 70 participants
- Where
- 1 siteGermany
- Study dates
- 15 Dec 2018to 31 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Residents from Mannheim/ Heidelberg who answered an open call to participate in this study
Who may be able to join
- 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
Who cannot join
- 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)
Show all 9Show fewer
- withdrawal symptoms (CIWA-R > 7)
- intoxication at time of investigation (breathalyzer > 0.3‰)
- suicidal tendency or potential danger for others
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim
About this study
Official title: Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders
Aversive childhood experiences (ACE) and their relation to the development of an alcohol use disorder will be measured with fMRI.
Read the 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.
- Conditions
- Alcohol Use Disorder, Trauma, Psychological
- Being tested
- No intervention
- Medical subject headings
- Alcoholism, Psychological Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called observational study
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Individuals with alcohol use disorder + ACE | Individuals with AUD and varying levels of adverse childhood experiences (ACE) Receives: Other: No intervention | |
| Healthy controls | Healthy individuals without AUD Receives: Other: No intervention | |
| Individuals with alcohol use disorder, no ACE | Individuals with AUD and no adverse childhood experiences (ACE) Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: fMRI measurement at one day only (day of fMRI experiment)
Secondary outcomes (3)
Hormonal stress response using salivary cortisol level
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].
Measured: 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
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].
Measured: 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
Genomic DNA using 40ml EDTA-blood
Measured: blood sample at one day only (day of fMRI experiment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2018
- Study start15 Dec 2018
- Primary completion27 May 2021
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Institute of Mental Health, Mannheim
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Sponsor
- Investigators
- Sabine Vollstaedt-Klein, Principal investigator, CIMH Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03758053
- Sponsor's protocol ID
- GRK2350-B5
- Status last verified
- Jul 2021
- First submitted
- 20 Aug 2018
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36577733
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress Sensitivity, Emotion Processing and Cue-reactivity: the Influence of Adverse Childhood Experiences in Substance-related Disorders
- ClinicalTrials.gov ID
- NCT03758053
- Acronym / sponsor ID
- GRK2350-B5
- Conditions
- Alcohol Use Disorder, Trauma, Psychological
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 15 Dec 2018 (actual)
- Primary completion
- 27 May 2021 (actual)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 29 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aversive childhood experiences (ACE) and their relation to the development of an alcohol use disorder will be measured with fMRI.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Individuals with alcohol use disorder + ACE | – | Other: No interventionIndividuals with AUD and varying levels of adverse childhood experiences (ACE) |
| Healthy controls | – | Other: No interventionHealthy individuals without AUD |
| Individuals with alcohol use disorder, no ACE | – | Other: No interventionIndividuals with AUD and no adverse childhood experiences (ACE) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Residents from Mannheim/ Heidelberg who answered an open call to participate in this study
Key inclusion criteria (8 listed)
- 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"
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionAlso: observational studyNo intervention | Other | Healthy controls, Individuals with alcohol use disorder + ACE, Individuals with alcohol use disorder, no ACE |
Primary outcome
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
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
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
3 secondary outcomes
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)
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)
GWAS and especially glutamatergic, serotonergic single-nucleotide polymorphisms
Time frame: blood sample at one day only (day of fMRI experiment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 36577733Gerhardt 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Vollstaedt-Klein principal investigator
CIMH Mannheim
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alcohol Use Disorder and Trauma, Psychological, run by Central Institute of Mental Health, Mannheim at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03758053, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.