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Clinical Trials/NCT03810950
NCT03810950
Completed
Not Applicable

Physiological, Neural and Behavioral Correlates of Psychosocial Stress and Alcohol Craving

Central Institute of Mental Health, Mannheim1 site in 1 country11 target enrollmentJanuary 1, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Use Disorder
Sponsor
Central Institute of Mental Health, Mannheim
Enrollment
11
Locations
1
Primary Endpoint
change in blood pressure (systolic and diastolic)
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2019
End Date
December 31, 2019
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Sponsor
Central Institute of Mental Health, Mannheim
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

acquired with pressure sleeve

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

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-reactivity

Time Frame: at 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 processing

Time Frame: at 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 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

heart rate acquired with ear clip (continuous time series)

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

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

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

time series acquired with body sensor

resting state activity

Time Frame: at 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 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

cortisol measured in saliva as a stress marker

neural emotion processing

Time Frame: at 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 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

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

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

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 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

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 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

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

Study Sites (1)

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