CompletedNot Applicable

Adverse Childhood Experiences in Alcohol Use Disorder

Germany43 participantsStarted 2021-11-22

Plain-language 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).

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

fMRI to assess group and within-subjects differences in task-specific brain activation patterns: Stress-sensitivity

Timeframe: 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

Timeframe: 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

Timeframe: fMRI measurement at one day only (day of fMRI experiment)

fMRI to assess group differences in task-specific brain activation patterns: Response inhibition

Timeframe: fMRI measurement at one day only (day of fMRI experiment)

fMRI to assess group differences in task-specific brain activation patterns: Working memory

Timeframe: fMRI measurement at one day only (day of fMRI experiment)

Long-term alcohol consumption

Timeframe: 2 - 2.5 year follow-up after first project

Trial details

NCT IDNCT05048758

SponsorCentral Institute of Mental Health, Mannheim

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-01-17

View on ClinicalTrials.gov More Alcohol Use Disorder trials