An interventional study of Trier Social Stress Test and Barlab Cue-Exposure in Alcohol Use Disorder, Stress Reaction and Social Stress, sponsored by Central Institute of Mental Health, Mannheim. Recruiting at 2 sites in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-29.
Sponsored by Central Institute of Mental Health, Mannheim · Not applicable, Interventional, and Treatment
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:
Participants will:
The main objective of the study is to identify longitudinal profiles and models of adaptive stress responses and stress resilience in individuals with alcohol use disorder (AUD) and understand how stress and different responses to it influence alcohol craving and alcohol use trajectories over time. To achieve these goals, the investigators will examine habituation vs. sensitization of cortisol responses to repeated experimental stress exposure in individuals with AUD, as an established experimental model to studying adaptive vs. non-adaptive stress responses in the framework of an experimental set-up including an initial rest period (30 minutes), followed by the Trier Social Stress Test (15 minutes), exposure to the favorite drink in a bar environment (9 minutes) and functional magnetic resonance imaging (75 minutes) assessing A) neural alcohol cue-reactivity, B) inhibition performance during a Stop Signal Task, C) emotion processing during a face-matching task and D) resting state connectivity. The investigators also seek to characterize the neurobehavioral underpinnings of sensitized vs. habituated responses to repeated stress exposure, using an established alcohol cue-reactivity fMRI paradigm, and determine the impact of sensitized vs. habituated stress responses on physiological and subjective stress markers, alcohol craving, alcohol use, as well as their modulation by prior stress exposure, social support, drinking goals and individual health behavior with a focus on potentially modifiable factors that could serve as targets for future ecological momentary interventions. This setup will be repeated on a second examination day.
In addition, the investigators aim to assess whether the observed habituation vs. sensitization phenotypes to repeated stress exposure translate into everyday-life of the respective individual and predict adaptive vs. non-adaptive stress responses. To this end, the investigators will acquire ambulatory assessments with high temporal resolution over six weeks, including detailed mapping of exposure to micro- and macro-stressors, drinking motifs, alcohol craving, alcohol use and data on factors that potentially modify the association between stress and alcohol use, such as social interactions, stress coping strategies, drinking goals and individual health behavior (e.g., sleep, physical activity) to assess whether the observed habituation vs. sensitization phenotypes to repeated stress exposure translate into everyday-life of the respective individual and predict real-life stress responses and alcohol use.
Study flow:
Screening (telephone): Assessing study eligibility
Experimental study visit 1: Rest period (30 minutes) - Trier Social Stress Test (15 minutes) - Alcohol cue exposure (9 minutes) - fMRI (75 minutes)
Experimental study visit 2: Repetition of setup from 'experimental study visit 1'
Following six weeks: Ambulatory phase (smartphone tool) with daily requests regarding stressors, alcohol craving and consumption as well as health behavior
1,674 studies on the registry are indexed under Alcoholism; 331 are open to participants now.
This study's planned enrollment of 100 is above the median of 88 across 1,428 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →Central Institute of Mental Health, Mannheim is the lead sponsor of 60 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria are:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All participants will be exposed to the Trier Social Stress Test, followed by an alcohol cue-exposure in a barlab environment and functional magnetic resonance imaging assessing neural alcohol cue-reactivity, inhibition performance, emotion processing and resting state functional connectivity twice on two consecutive days. Interventions: Behavioral: Trier Social Stress Test Behavioral: Cue-Exposure to the favorite drink in a barlab setting
Behavioral: Trier Social Stress Test · Behavioral: Barlab Cue-Exposure · Behavioral: Functional magnetic resonance imaging
Test to induce high levels of acute social stress, including actors, representing the judging panel, and a faked exam situation (15 minutes duration).
Participants are exposed to a bar situation with their individual favorite alcohol presented. They handle their favorite alcoholic drink and water (9 minutes duration).
Participants undergo a fMRI screening including three different behavioral tasks assessing alcohol cue reactivity, response inhibition, and emotion processing
Cortisol
Cortisol levels measured in saliva as a stress marker (in nmol/l)
Time frame: 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
self-report questionnaire: "Alcohol Urge Questionnaire (AUQ)" with Bohn et al. 1995; containing 8 items; each item will be rated on a 7-point-Likert-Scale from 1 "not true at all" (minimum) to 7 "completely true" (maximum); sum score is defined as outcome and higher outcome reflects higher alcohol urges
Time frame: 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
self-report "How strong is your craving for alcohol?"; containing 1 item; reported on a visual analogue scale ranging from 0 ("no craving") to 100 ("very strong craving")
Time frame: 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]
Subjective stress level
self-report questionnaire: "Primary Appraisal Secondary Appraisal (PASA)"; Gaab, 2009; containing 16 items; each item will be rated on a 6-Point-Scale from 1 ("completely wrong") to 6 ("quite right"); sum score is defined as outcome and higher outcome reflects a higher subjective stress level
Time frame: 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]
Neural alcohol-related cue-reactivity
percent signal change from baseline condition (i.e. fixation cross), measured with fMRI; paradigm Vollstädt-Klein et al. 2010; \[percent signal change is not a change over time; it is measured during one experimental session\]; presentation of neutral and alcoholic (categories: beer, wine, spirits) stimuli in 20 blocks (blocked design; one block à 5 stimuli each presented for 4 seconds), after each block participants had to rate their craving: "I have alcohol craving." from 0 ("no craving at all") to 100 ("severe craving"), maximum rating duration is 10 seconds, following the rating a fixation cross was presented (10 seconds), total task duration: 12 minutes
Time frame: at examination day: after 1:00 hour of the experimental procedure
Neural inhibition processing
percent signal change from baseline condition (i.e. fixation cross), measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) \[percent signal change is not a change over time; it is measured during one experimental session\]; conduction of a stop-signal task of 600 trials (500 go-trials and 100 stop trials, participant have to respond as quickly as possible by pressing the left or right button according to the arrow direction, between the trials a fixation cross was presented (for 700 milliseconds to 1100 milliseconds), total task duration: 19 minutes
Time frame: at examination day: after 1:00 hour of the experimental procedure
Neural emotion processing
percent signal change from baseline condition (i.e. fixation cross), measured with fMRI; faces task (Hariri et al. 2002) \[percent signal change is not a change over time; it is measured during one experimental session\]; participants were exposed to faces with varying emotions and forms (geometric shapes as a sensorimotor control task) and had to match one of two simultaneously presented images with an identical target image, a total of nine blocks (four with faces, five controls) each lasting 32 seconds and a total duration of about five minutes
Time frame: at examination day: after 1:00 hour of the experimental procedure
Resting state activity
resting state connectivity measured with fMRI
Time frame: at examination day: after 1:00 hour of the experimental procedure
Ecological momentary assessment
Self-report ratings of: Real-life alcohol craving with the item "How strong is your current alcohol craving?", rating with a 7-Point-Likert-Scale from 1 "no craving" to 7 "extreme craving"; of stress exposure with the item "How strong is your current level of stress?", rating with a 7-Point-Likert-Scale from 1 "not at all" to 7 "very stressed"; of alcohol consumption with the item "Remember yesterday: Which and how many alcoholic drinks did you consume?", a short-list with listed drinks and amounts will open from which participants can choose; and of stress coping with the item "How did you deal with unpleasant situations since the last prompt?", rating with a 5-Point-Likert-Scale from 1 "not at all" to 5 "excellent"
Time frame: starting at the examination day until 6 weeks later; daily requests
Blood pressure (systolic and diastolic)
acquired with pressure sleeve (in mmHg)
Time frame: 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]
Plan to share: No
Started Dec 2023 (actual). Primary completion is estimated for Jun 2027, 42 months after the start.
Of 470 non-industry interventional studies with no phase under Alcoholism, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 55. This study's planned 42 months is above that.
Counting every sponsor, half of 493 studies reached it within 33 months; a quarter within 17 and three quarters within 53.
How these figures are worked out, and which studies are left out of them.
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Central Institute of Mental Health, Mannheim