Alcohol Use DisorderNCT05048758
Adverse Childhood Experiences in Alcohol Use Disorder
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
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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alcohol Use Disorder, Trauma, Psychological
- How many people
- 43 participants
- Where
- 1 siteGermany
- Study dates
- 22 Nov 2021to 17 Jan 2024
- 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
- No healthy volunteers
- Adult, Older adult
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.
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"
- 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
Who cannot join
- 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)
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, Baden-Wurttemberg, 68159
About this study
Official title: Vulnerability for Alcohol Use Disorder After ACE: the Role of Stress Sensitivity, Emotion Processing, Cue Reactivity and Cognitive Functions in Relapse Risk
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).
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 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.
- 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 AUD + varying levels of ACE | Individuals with alcohol use disorder (AUD) and varying levels of 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 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: fMRI measurement at one day only (day of fMRI experiment)
Long-term alcohol consumption
Self-report in longitudinal sample measured with the LDH interview
Measured: 2 - 2.5 year follow-up after first project
Short-term alcohol consumption
Self-report in whole sample measured with the Form 90 interview
Measured: 3-month follow-up after current project
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
Time course of salivary cortisol level. Area under the curve and slope will be calculated [nmol/L]
Measured: 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 posted17 Sep 2021
- Study start22 Nov 2021
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
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
- Other
- Time perspective
- Prospective
- Enrolment
- 43 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, PhD, Principal investigator, Central Institute of Mental Health, Mannheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05048758
- Sponsor's protocol ID
- GRK2350-B5-P2
- Status last verified
- Mar 2024
- First submitted
- 8 Sep 2021
- Last updated
- 29 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35772833
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vulnerability for Alcohol Use Disorder After ACE: the Role of Stress Sensitivity, Emotion Processing, Cue Reactivity and Cognitive Functions in Relapse Risk
- ClinicalTrials.gov ID
- NCT05048758
- Acronym / sponsor ID
- GRK2350-B5-P2
- Conditions
- Alcohol Use Disorder, Trauma, Psychological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Central Institute of Mental Health, MannheimUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 17 Sep 2021 (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.
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).
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
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Individuals with AUD + varying levels of ACE | – | Other: No interventionIndividuals with alcohol use disorder (AUD) and varying levels of adverse childhood experiences (ACE) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 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, 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)
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 | Individuals with AUD + varying levels of ACE |
Primary outcome
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
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
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
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.
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.
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
Short-term alcohol consumption
Time frame: 3-month follow-up after current project
Self-report in whole sample measured with the Form 90 interview
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: 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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2024.
- Derived from this study: PubMed 35772833Turkmen 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.
Related trials for Alcohol Use Disorder
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruiting
Substance Use and Media Preferences
Substance Use Behavior, Cannabis Intoxication
RecruitingPhase 1
Environment and Alcohol: A Pilot Study
Alcohol Use Disorder
RecruitingObservational study
SMART-r: Substance Monitoring and Active Relapse Tracking Repository
Alcoholism, Substance-Related Disorders
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
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, PhD principal investigator
Central Institute of Mental Health, 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 7 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: finished, as of the sponsor's last update on 29 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 and within-subjects differences in task-specific brain activation patterns: Stress-sensitivity (time frame: fMRI measurement at one day only (day of fMRI experiment)). The study lists 7 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 NCT05048758, 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 Mar 2024.