RecruitingNot Applicable

Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder

Germany100 participantsStarted 2023-12-01

Plain-language summary

The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are: What are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to: * alcohol craving? * alcohol use? * their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior? Participants will: * be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test * be exposed to their favorite drink in a bar lab environment * be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing * conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.

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 are: * age between 16 and 65 years * meeting at least 2 criteria of an alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), yet without the need for a therapeutic intervention * fluency in German * able to understand the study procedures and give informed consent * willingness to use a study smartphone Exclusion criteria are: * current use of drugs or medications that interact with the central nervous system or the glucocorticoid system * contraindications for magnetic resonance imaging * medical history of bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance use disorder other than alcohol, nicotine, or cannabis * medical history of severe head injury or other severe central nervous system disorders or other severe somatic disorders (e.g. liver cirrhosis) * pregnancy

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

Cortisol

Timeframe: Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours]; after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]

Alcohol urges

Timeframe: Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours], after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]

Alcohol craving

Subjective stress level

Neural alcohol-related cue-reactivity

Timeframe: at examination day: after 1:00 hour of the experimental procedure

Trial details

NCT IDNCT06105853

SponsorCentral Institute of Mental Health, Mannheim

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-06-30

Contact for this trial

Patrick Bach, MD, PhD

+49 621 1703 patrick.bach@zi-mannheim.de

View on ClinicalTrials.gov More Alcohol Use Disorder trials