- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03810950
Psychobiology of Stress and Alcohol Craving
Physiological, Neural and Behavioral Correlates of Psychosocial Stress and Alcohol Craving
Study Overview
Status
Intervention / Treatment
Detailed Description
The long-term aim is the definition of a setup of mobile sensors and their integration in a mobile infrastructure that allows the prediction of stress related alcohol intake in an ambulatory setting.
In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, the investigators aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity). In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the investigators will integrate innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Mannheim, Germany
- Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Heavy drinking, defined by alcohol consumption of at least 20g alcohol per day (at 5 days per week)
- sufficient ability to communicate with the investigators, to answer questions in oral and written form
- fully informed consent
- written informed consent
Exclusion Criteria:
- withdrawal of the declaration of consent
- positive urin drug screening (cannabis, amphetamine, opiates, benzodiazepines, cocaine)
- Lifetime history of DSM-5 bipolar disorder, schizophrenia or schizophrenia spectrum disorder, or substance dependence other than alcohol or nicotine or cannabis dependence.
- Current threshold DSM-5 diagnosis of major depressive disorder, or presence of suicidal intention
- History of severe head trauma or other severe central nervous system disorder (e.g., dementia, Parkinson's disease, multiple sclerosis)
- Current use of medications or drugs known to interact with the CNS within at least four half-lives post last intake
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Social Stress Test
Participants undergo the Trier Social Stress Test before Barlab-Exposure
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Test to induce high levels of acute social stress, including actors and a faked exam situation
Participants are exposed to a bar situation with different sorts of alcohol available.
They sniff at water and at one alcoholic drink.
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Active Comparator: Control Condition
Participants reads newspaper before Barlab-Exposure
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Participants are exposed to a bar situation with different sorts of alcohol available.
They sniff at water and at one alcoholic drink.
Participants read newspaper
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
change in heart rate
Time Frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
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heart rate acquired with ear clip (continuous time series)
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at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
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change in heart rate variability
Time Frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
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heart rate variability acquired with ear clip (continuous time series)
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at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hours; starting 1 hour 50 minutes after arrival of the proband
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change in blood pressure (systolic and diastolic)
Time Frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at 2:20h, 2:50h, 3:20h, 3:50h, 4:50h, 5:05h after arrival of the proband
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acquired with pressure sleeve
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at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at 2:20h, 2:50h, 3:20h, 3:50h, 4:50h, 5:05h after arrival of the proband
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change in electrodermal activity
Time Frame: at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband
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time series acquired with body sensor
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at examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband
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neural alcohol-related cue-reactivity
Time Frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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% signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010 [% signal change is not a change over time; it is measured during one experimental session]
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at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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neural inhibition processing
Time Frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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% signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) [% signal change is not a change over time; it is measured during one experimental session]
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at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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neural emotion processing
Time Frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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% signal change, measured with fMRI; faces task (Hariri et al. 2002) [% signal change is not a change over time; it is measured during one experimental session]
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at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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resting state activity
Time Frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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resting state connectivity measured with fMRI
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at examination day: measured directly after the behavioral tasks at the end of the lab experiment
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attentional bias to alcohol cues
Time Frame: at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
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measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) [reaction time differences is not a change over time; it is measured during one experimental session]
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at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
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implicit alcohol association
Time Frame: at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
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measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) [reaction time differences is not a change over time; it is measured during one experimental session]
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at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
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change in level of cortisol
Time Frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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cortisol measured in saliva as a stress marker
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at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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change in voice stress pattern
Time Frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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audio file of participants' voice for voice stress pattern analysis will be recorded.
From this a multivariate measure (i.e.
multivariate vector) will be acquired (including frequency, loudness etc.)
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at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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change in alcohol urges
Time Frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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elf-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
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at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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change in alcohol craving
Time Frame: at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
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at examination day: 6 time points measured throughout the whole experiment (except during MRI scanning); at hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 after arrival of the proband
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Collaborators and Investigators
Investigators
- Principal Investigator: Sabine Vollstädt-Klein, Prof. Dr., Central Institute of Mental Health, Mannheim
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TRR265 A03-Pilot
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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