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Psychobiology of Stress and Alcohol Craving

Not Applicable
Completed
Conditions
Craving
Behavior
Stress Reaction
Alcohol Use Disorder
Social Stress
Interventions
Behavioral: Reading Newspaper
Behavioral: Trier Social Stress Test
Behavioral: Barlab-Exposure
Registration Number
NCT03810950
Lead Sponsor
Central Institute of Mental Health, Mannheim
Brief Summary

In this feasibility study the investigators are using a setup of stress-related body sensors including established as well as innovative sensor-based measures to identify predictor profiles for alcohol-related behavioral and neural measures in Alcohol Use Disorder (AUD). 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.

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
11
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Control ConditionReading NewspaperParticipants reads newspaper before Barlab-Exposure
Social Stress TestBarlab-ExposureParticipants undergo the Trier Social Stress Test before Barlab-Exposure
Control ConditionBarlab-ExposureParticipants reads newspaper before Barlab-Exposure
Social Stress TestTrier Social Stress TestParticipants undergo the Trier Social Stress Test before Barlab-Exposure
Primary Outcome Measures
NameTimeMethod
change in blood pressure (systolic and diastolic)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

acquired with pressure sleeve

implicit alcohol associationat examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session

measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) \[reaction time differences is not a change over time; it is measured during one experimental session\]

neural alcohol-related cue-reactivityat examination day: measured directly after the behavioral tasks at the end of the lab experiment

% signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010 \[% signal change is not a change over time; it is measured during one experimental session\]

neural inhibition processingat examination day: measured directly after the behavioral tasks at the end of the lab experiment

% signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) \[% signal change is not a change over time; it is measured during one experimental session\]

change in heart rateat 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

heart rate acquired with ear clip (continuous time series)

change in heart rate variabilityat 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

heart rate variability acquired with ear clip (continuous time series)

change in electrodermal activityat examination day: continuous measurement throughout the whole experiment (except during MRI scanning); duration around 2 hour; starting 1h 50min after arrival of the proband

time series acquired with body sensor

resting state activityat examination day: measured directly after the behavioral tasks at the end of the lab experiment

resting state connectivity measured with fMRI

change in level of cortisolat 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

cortisol measured in saliva as a stress marker

neural emotion processingat examination day: measured directly after the behavioral tasks at the end of the lab experiment

% signal change, measured with fMRI; faces task (Hariri et al. 2002) \[% signal change is not a change over time; it is measured during one experimental session\]

change in alcohol urgesat 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

elf-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995

attentional bias to alcohol cuesat examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session

measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) \[reaction time differences is not a change over time; it is measured during one experimental session\]

change in voice stress patternat 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

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.)

change in alcohol cravingat 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

self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

🇩🇪

Mannheim, Germany

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