Ignite Creation Date:
2024-05-06 @ 7:42 PM
Last Modification Date:
2024-10-26 @ 3:12 PM
Study NCT ID:
NCT06105853
Status:
RECRUITING
Last Update Posted:
2024-01-31
First Post:
2023-09-14
Brief Title:
Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder
Sponsor:
Central Institute of Mental Health Mannheim
Organization:
Central Institute of Mental Health Mannheim
Study Overview
Official Title:
Towards Neurobehavioral Profiles and Models of Adaptive Stress Responses and Resilience in Individuals With Alcohol Use Disorder
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
A03
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
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
Detailed Description:
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 eg 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
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 eg 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None