Understanding stress responses in individuals with alcohol use disorder
Towards Neurobehavioral Profiles and Models of Adaptive Stress Responses and Resilience in Individuals With Alcohol Use Disorder
This study looks at how people with alcohol use disorder react to stress and whether these reactions affect their cravings and drinking habits over time.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Central Institute of Mental Health, Mannheim Academic / other |
| Locations | 2 sites (Mannheim, Baden-Wurttemberg and 1 other locations) |
| Trial ID | NCT06105853 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the neurobehavioral profiles of stress responses in individuals with alcohol use disorder (AUD). Participants will undergo a series of assessments, including the Trier Social Stress Test and functional magnetic resonance imaging (fMRI), to evaluate their responses to stress and alcohol cues. The study will explore how different stress responses influence alcohol craving and usage over time, focusing on factors such as prior stress exposure and coping strategies. By examining these dynamics, the research seeks to identify patterns of resilience and vulnerability in AUD.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 16 to 65 who meet at least two criteria for alcohol use disorder but do not require therapeutic intervention.
Not a fit: Patients with current substance use disorders other than alcohol, severe mental health conditions, or contraindications for MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and treatment strategies for individuals with alcohol use disorder by identifying adaptive stress responses.
How similar studies have performed: Other studies have shown success in exploring stress responses in addiction, but this specific approach focusing on neurobehavioral profiles in AUD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Mannheim, Baden-Wurttemberg and 1 other locations
- Central Institute of Mental Health — Mannheim, Baden-Wurttemberg, Germany (Recruiting)
- Central Institute of Mental Health — Mannheim, Germany (Recruiting)
Study contacts
- Principal investigator: Patrick Bach, MD, PhD — Central Institute of Mental Health
- Study coordinator: Patrick Bach, MD, PhD
- Email: patrick.bach@zi-mannheim.de
- Phone: +49 621 1703
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.