Stress-related Predictor Profiles in Human Addiction
Primary Purpose
Alcohol Use Disorder, Stress Reaction, Social Stress
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Trier Social Stress Test
Ergometer
Barlab-Exposure
Reading Newspaper
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol Use Disorder
Eligibility Criteria
Inclusion Criteria:
- Alcohol-use disorder according to 2 DSM-V criteria not requiring detoxification: AUD subjects with mild AUD will fulfill at least 2 and not more than 5 diagnostic criteria; a second group of AUD subjects will fulfill 4-5 criteria for moderate AUD
- 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
- Pregnancy
- Using hormonal contraceptives
- Perimenopausal/ postmenopausal
- 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 3
Arm Type
Active Comparator
Experimental
Experimental
Arm Label
Control
Experimental 1 (Distress)
Experimental 2 (Eustress)
Arm Description
Participants reads newspaper before Barlab-Exposure
Participants undergo the Trier Social Stress Test before Barlab-Exposure
Participants ride an ergometer 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
fMRI
neural alcohol-related cue-reactivity, stop-signal reaction time task, emotion processing and resting state 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
self-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
alcohol consumption
self-report using the instrument Form90 (Scheurich et al. 2005)
Full Information
NCT ID
NCT03810924
First Posted
November 26, 2018
Last Updated
September 14, 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
NCT03810924
Brief Title
Stress-related Predictor Profiles in Human Addiction
Official Title
Stress-related Predictor Profiles for Craving and Relapse in Human Addiction
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
July 8, 2023 (Actual)
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
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. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on measures relevant for the development and maintenance of Alcohol Use Disorder (AUD). Further, we aim to identify neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers, we will integrate innovative sensor-based measures.
Detailed Description
In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, we aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological vs. physical stress exposure and alcohol cue-exposure regarding their effects on (1) alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity), (2) their predictive capacity for future alcohol intake, (3) the identification their neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), (4) we will integrate portable sensors (wearables) to allow a future integration in ambulatory assessments and to test innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance. Our 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.
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, Relapse, Addiction, Risk Behavior
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
121 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants reads newspaper before Barlab-Exposure
Arm Title
Experimental 1 (Distress)
Arm Type
Experimental
Arm Description
Participants undergo the Trier Social Stress Test before Barlab-Exposure
Arm Title
Experimental 2 (Eustress)
Arm Type
Experimental
Arm Description
Participants ride an ergometer 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)
Ergometer
Intervention Description
Riding ergometer
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.
Intervention Type
Behavioral
Intervention Name(s)
Reading Newspaper
Intervention Description
Participants read newspaper
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 hour; 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 hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 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
fMRI
Description
neural alcohol-related cue-reactivity, stop-signal reaction time task, emotion processing and resting state 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
self-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
Secondary Outcome Measure Information:
Title
alcohol consumption
Description
self-report using the instrument Form90 (Scheurich et al. 2005)
Time Frame
12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alcohol-use disorder according to 2 DSM-V criteria not requiring detoxification: AUD subjects with mild AUD will fulfill at least 2 and not more than 5 diagnostic criteria; a second group of AUD subjects will fulfill 4-5 criteria for moderate AUD
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
Pregnancy
Using hormonal contraceptives
Perimenopausal/ postmenopausal
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
Falk Kiefer, Prof.
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
State/Province
Baden-Württemberg
ZIP/Postal Code
68159
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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Stress-related Predictor Profiles in Human Addiction
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