Psychobiology of Stress and Alcohol Craving
Primary Purpose
Alcohol Use Disorder, Stress Reaction, Social Stress
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Trier Social Stress Test
Reading Newspaper
Barlab-Exposure
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
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
Sites / Locations
- Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Social Stress Test
Control Condition
Arm Description
Participants undergo the Trier Social Stress Test before Barlab-Exposure
Participants reads newspaper before Barlab-Exposure
Outcomes
Primary Outcome Measures
change in heart rate
heart rate acquired with ear clip (continuous time series)
change in heart rate variability
heart rate variability acquired with ear clip (continuous time series)
change in blood pressure (systolic and diastolic)
acquired with pressure sleeve
change in electrodermal activity
time series acquired with body sensor
neural alcohol-related cue-reactivity
% 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
% 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]
neural emotion processing
% 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]
resting state activity
resting state connectivity measured with fMRI
attentional bias to alcohol cues
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]
implicit alcohol association
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]
change in level of cortisol
cortisol measured in saliva as a stress marker
change in voice stress pattern
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 urges
elf-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
change in alcohol craving
self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
Secondary Outcome Measures
Full Information
NCT ID
NCT03810950
First Posted
November 26, 2018
Last Updated
January 24, 2023
Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim
1. Study Identification
Unique Protocol Identification Number
NCT03810950
Brief Title
Psychobiology of Stress and Alcohol Craving
Official Title
Physiological, Neural and Behavioral Correlates of Psychosocial Stress and Alcohol Craving
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Central Institute of Mental Health, Mannheim
Collaborators
Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol Use Disorder, Stress Reaction, Social Stress, Craving, Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Social Stress Test
Arm Type
Experimental
Arm Description
Participants undergo the Trier Social Stress Test before Barlab-Exposure
Arm Title
Control Condition
Arm Type
Active Comparator
Arm Description
Participants reads newspaper before Barlab-Exposure
Intervention Type
Behavioral
Intervention Name(s)
Trier Social Stress Test
Intervention Description
Test to induce high levels of acute social stress, including actors and a faked exam situation
Intervention Type
Behavioral
Intervention Name(s)
Reading Newspaper
Intervention Description
Participants read newspaper
Intervention Type
Behavioral
Intervention Name(s)
Barlab-Exposure
Intervention Description
Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.
Primary Outcome Measure Information:
Title
change in heart rate
Description
heart rate acquired with ear clip (continuous time series)
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
Title
change in heart rate variability
Description
heart rate variability acquired with ear clip (continuous time series)
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
Title
change in blood pressure (systolic and diastolic)
Description
acquired with pressure sleeve
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
Title
change in electrodermal activity
Description
time series acquired with body sensor
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
Title
neural alcohol-related cue-reactivity
Description
% 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]
Time Frame
at examination day: measured directly after the behavioral tasks at the end of the lab experiment
Title
neural inhibition processing
Description
% 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]
Time Frame
at examination day: measured directly after the behavioral tasks at the end of the lab experiment
Title
neural emotion processing
Description
% 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]
Time Frame
at examination day: measured directly after the behavioral tasks at the end of the lab experiment
Title
resting state activity
Description
resting state connectivity measured with fMRI
Time Frame
at examination day: measured directly after the behavioral tasks at the end of the lab experiment
Title
attentional bias to alcohol cues
Description
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]
Time Frame
at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
Title
implicit alcohol association
Description
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]
Time Frame
at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
Title
change in level of cortisol
Description
cortisol measured in saliva as a stress marker
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
Title
change in voice stress pattern
Description
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.)
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
Title
change in alcohol urges
Description
elf-report questionnaire: "Alcohol Urge Questionnaire (AUQ)"; Bohn et al. 1995
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
Title
change in alcohol craving
Description
self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100
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
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Vollstädt-Klein, Prof. Dr.
Organizational Affiliation
Central Institute of Mental Health, Mannheim
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
City
Mannheim
Country
Germany
12. IPD Sharing Statement
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Psychobiology of Stress and Alcohol Craving
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