NCT06105853 Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder
| NCT ID | NCT06105853 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Central Institute of Mental Health, Mannheim |
| Condition | Alcohol Use Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-12-01 |
| Primary Completion | 2027-06-30 |
Trial Parameters
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Brief 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.
Eligibility Criteria
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