Clinical trial NCT03810950: Psychobiology of Stress and Alcohol Craving
Official title: Physiological, Neural and Behavioral Correlates of Psychosocial Stress and Alcohol Craving
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Stress Reaction
Social Stress
Craving
Behavior
Lead sponsor: Central Institute of Mental Health, Mannheim
Sponsor class: OTHER
Collaborators: name: Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim
First posted: 2019-01-22
Enrollment: 11
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: change in heart rate
timeFrame: 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
measure: change in heart rate variability
timeFrame: 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
measure: change in blood pressure (systolic and diastolic)
timeFrame: 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
measure: change in electrodermal activity
timeFrame: 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
measure: neural alcohol-related cue-reactivity
timeFrame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
measure: neural inhibition processing
timeFrame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
measure: neural emotion processing
timeFrame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
measure: resting state activity
timeFrame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment
measure: attentional bias to alcohol cues
timeFrame: at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session
measure: implicit alcohol association
timeFrame: at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session
measure: change in level of cortisol
timeFrame: 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
measure: change in voice stress pattern
timeFrame: 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
measure: change in alcohol urges
timeFrame: 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
measure: change in alcohol craving
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Mannheim
country: Germany
facility: Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Study officials:
affiliation: Central Institute of Mental Health, Mannheim
name: Sabine Vollstädt-Klein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: