Neurobehavioral Profiles of Adaptive Stress Responses in Individuals With Alcohol Use Disorder

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorCentral Institute of Mental Health, Mannheim

About this trial

The goal of this observational study is to investigate longitudinal stress response profiles and adaptive versus non-adaptive stress responses in alcohol use disorder. The main questions the projects aims to answer are:

What are the neurobehavioral underpinnings of adaptive stress responses and resilience to repeated stress exposure with regards to:

* alcohol craving? * alcohol use? * their modulation by prior stress exposure, social interactions, coping strategies and individual health behavior?

Participants will:

* be exposed to an established experimental stress-induction protocol, the Trier Social Stress Test * be exposed to their favorite drink in a bar lab environment * be assessed using fMRI to determine their neural alcohol cue reactivity, response inhibition, and emotion processing * conduct an ambulatory phase to assess stressors, alcohol craving, substance use and details on social interactions, health behavior and coping strategies using ecological momentary assessment tools.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age between 16 and 65 years

meeting at least 2 criteria of an alcohol use disorder according to the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition) (DSM-5), yet without the need for a therapeutic intervention

fluency in German

able to understand the study procedures and give informed consent

Disqualifiers

current use of drugs or medications that interact with the central nervous system or the glucocorticoid system

contraindications for magnetic resonance imaging

medical history of bipolar disorder, psychotic disorder, schizophrenia or schizophrenic spectrum disorder, or substance use disorder other than alcohol, nicotine, or cannabis

medical history of severe head injury or other severe central nervous system disorders or other severe somatic disorders (e.g. liver cirrhosis)

Trial design

Design model

Single group

Treatments tested in this trial

  • Trier Social Stress Test

    Behavioral

    Test to induce high levels of acute social stress, including actors, representing the judging panel, and a faked exam situation (15 minutes duration).

  • Barlab Cue-Exposure

    Behavioral

    Participants are exposed to a bar situation with their individual favorite alcohol presented. They handle their favorite alcoholic drink and water (9 minutes duration).

  • Functional magnetic resonance imaging

    Behavioral

    Participants undergo a fMRI screening including three different behavioral tasks assessing alcohol cue reactivity, response inhibition, and emotion processing

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Cortisol

Cortisol levels measured in saliva as a stress marker (in nmol/l)

Time frame
Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours]; after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]
2

Alcohol urges

self-report questionnaire: "Alcohol Urge Questionnaire (AUQ)" with Bohn et al. 1995; containing 8 items; each item will be rated on a 7-point-Likert-Scale from 1 "not true at all" (minimum) to 7 "completely true" (maximum); sum score is defined as outcome and higher outcome reflects higher alcohol urges

Time frame
Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours], after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]
3

Alcohol craving

self-report "How strong is your craving for alcohol?"; containing 1 item; reported on a visual analogue scale ranging from 0 ("no craving") to 100 ("very strong craving")

Time frame
Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours]; after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]
4

Subjective stress level

self-report questionnaire: "Primary Appraisal Secondary Appraisal (PASA)"; Gaab, 2009; containing 16 items; each item will be rated on a 6-Point-Scale from 1 ("completely wrong") to 6 ("quite right"); sum score is defined as outcome and higher outcome reflects a higher subjective stress level

Time frame
Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours]; after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]

Secondary outcomes

1

Blood pressure (systolic and diastolic)

acquired with pressure sleeve (in mmHg)

Time frame
Assessed at 4 time points at each examination day: after a 30-minute rest period [0:30 hours]; after the 15-minute stress intervention [0:45 hours]; after the 9-minute Barlab exposure [0:54 hours]; after the 75-minute fMRI [2:09 hours]

Other outcomes

Sponsors and contacts

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