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Completed

NCT Number: NCT03810924

Stress-related Predictor Profiles in Human Addiction

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Baden-Wurttemberg, 68159, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

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

Ergometer

Behavioral

Riding ergometer

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.

Reading Newspaper

Behavioral

Participants read newspaper

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 hour; 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 hours:minutes 2:20, 2:50, 3:20, 3:50, 4:50, 5:05 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. fMRI

    Time frame: at examination day: measured directly after the behavioral tasks at the end of the lab experiment

    neural alcohol-related cue-reactivity, stop-signal reaction time task, emotion processing and resting state fMRI

  10. 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]

  11. 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]

  12. 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

  13. 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.)

  14. 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

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

  15. 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

Secondary outcomes

  1. alcohol consumption

    Time frame: 12 months follow-up

    self-report using the instrument Form90 (Scheurich et al. 2005)

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

Stress-related Predictor Profiles for Craving and Relapse in Human Addiction

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Jan 22, 2019
Registry last updated
Sep 15, 2023

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.

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