Skip to main content
OpenTrials
Completed

NCT Number: NCT03810950

Psychobiology of Stress and Alcohol Craving

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alcohol Use Disorder Alcohol-Related Disorders Alcoholism Behavior Chemically-Induced Disorders Craving Fractures, Bone Fractures, Stress Mental Disorders Social Stress Stress Reaction Substance-Related Disorders Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trier Social Stress Test

Behavioral

Test to induce high levels of acute social stress, including actors and a faked exam situation

Reading Newspaper

Behavioral

Participants read newspaper

Barlab-Exposure

Behavioral

Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.

Primary outcomes

  1. 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)

  2. 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)

  3. 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

  4. 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

  5. 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]

  6. 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]

  7. 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]

  8. 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

  9. 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]

  10. 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]

  11. 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

  12. 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.)

  13. 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

  14. 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

Sponsors and collaborators

Lead sponsor

Central Institute of Mental Health, Mannheim

Other

Collaborators

  • Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jan 22, 2019
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.