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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study summary

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

Primary outcome measure(s)

• Cortisol — 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]
  Cortisol levels measured in saliva as a stress marker (in nmol/l)
• Alcohol urges — 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]
  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
• Alcohol craving — 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]
  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")
• Subjective stress level — 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]
  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
• Neural alcohol-related cue-reactivity — at examination day: after 1:00 hour of the experimental procedure
  percent signal change from baseline condition (i.e. fixation cross), measured with fMRI; paradigm Vollstädt-Klein et al. 2010; \[percent signal change is not a change over time; it is measured during one experimental session\]; presentation of neutral and alcoholic (categories: beer, wine, spirits) stimuli in 20 blocks (blocked design; one block à 5 stimuli each presented for 4 seconds), after each block participants had to rate their craving: "I have alcohol craving." from 0 ("no craving at all") to 100 ("severe craving"), maximum rating duration is 10 seconds, following the rating a fixation cross was presented (10 seconds), total task duration: 12 minutes
• Neural inhibition processing — at examination day: after 1:00 hour of the experimental procedure
  percent signal change from baseline condition (i.e. fixation cross), measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) \[percent signal change is not a change over time; it is measured during one experimental session\]; conduction of a stop-signal task of 600 trials (500 go-trials and 100 stop trials, participant have to respond as quickly as possible by pressing the left or right button according to the arrow direction, between the trials a fixation cross was presented (for 700 milliseconds to 1100 milliseconds), total task duration: 19 minutes
• Neural emotion processing — at examination day: after 1:00 hour of the experimental procedure
  percent signal change from baseline condition (i.e. fixation cross), measured with fMRI; faces task (Hariri et al. 2002) \[percent signal change is not a change over time; it is measured during one experimental session\]; participants were exposed to faces with varying emotions and forms (geometric shapes as a sensorimotor control task) and had to match one of two simultaneously presented images with an identical target image, a total of nine blocks (four with faces, five controls) each lasting 32 seconds and a total duration of about five minutes
• Resting state activity — at examination day: after 1:00 hour of the experimental procedure
  resting state connectivity measured with fMRI
• Ecological momentary assessment — starting at the examination day until 6 weeks later; daily requests
  Self-report ratings of: Real-life alcohol craving with the item "How strong is your current alcohol craving?", rating with a 7-Point-Likert-Scale from 1 "no craving" to 7 "extreme craving"; of stress exposure with the item "How strong is your current level of stress?", rating with a 7-Point-Likert-Scale from 1 "not at all" to 7 "very stressed"; of alcohol consumption with the item "Remember yesterday: Which and how many alcoholic drinks did you consume?", a short-list with listed drinks and amounts will open from which participants can choose; and of stress coping with the item "How did you deal with unpleasant situations since the last prompt?", rating with a 5-Point-Likert-Scale from 1 "not at all" to 5 "excellent"

Trial sites (2)

More Central Institute of Mental Health, Mannheim trials in Germany

Other trials for the same condition