Psychobiology of Stress and Alcohol Craving

NCT03810950 | Completed

• 1 other identifier: TRR265 A03-Pilot
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Alcohol Use Disorder; Stress Reaction; Social Stress; Craving; Behavior

Outcome Measures

Primary Outcomes (14)

• change in heart rate

  heart rate acquired with ear clip (continuous time series)

  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

• change in heart rate variability

  heart rate variability acquired with ear clip (continuous time series)

  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

• change in blood pressure (systolic and diastolic)

  acquired with pressure sleeve

  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

• change in electrodermal activity

  time series acquired with body sensor

  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

• neural alcohol-related cue-reactivity

  % signal change, measured with fMRI; paradigm Vollstädt-Klein et al. 2010 \[% signal change is not a change over time; it is measured during one experimental session\]

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

• neural inhibition processing

  % signal change, measured with fMRI; stop-signal reaction time task (Fauth-Buhler et al. 2012) \[% signal change is not a change over time; it is measured during one experimental session\]

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

• neural emotion processing

  % signal change, measured with fMRI; faces task (Hariri et al. 2002) \[% signal change is not a change over time; it is measured during one experimental session\]

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

• resting state activity

  resting state connectivity measured with fMRI

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

• attentional bias to alcohol cues

  measured with reaction time differences (in milliseconds) using the dotprobe-task (Vollstädt-Klein et al. 2009) \[reaction time differences is not a change over time; it is measured during one experimental session\]

  at examination day: measured directly after the stress task / newspaper reading; before "implicit alcohol association" and MRI session

• implicit alcohol association

  measured with reaction time differences (in milliseconds) using the implicit association task (Wiers et al. 2016) \[reaction time differences is not a change over time; it is measured during one experimental session\]

  at examination day: measured after the stress task / newspaper reading, directly after the "attentional bias to alcohol cues" ; before MRI session

• change in level of cortisol

  cortisol measured in saliva as a stress marker

  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

• change in voice stress pattern

  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.)

  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

• change in alcohol urges

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

  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

• change in alcohol craving

  self-report "How strong is your craving for alcohol?": reported on a visual analogue scale ranging from 0 to 100

  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

Study Arms (2)

Social Stress Test

EXPERIMENTAL

Participants undergo the Trier Social Stress Test before Barlab-Exposure

Behavioral: Trier Social Stress Test; Behavioral: Barlab-Exposure

Control Condition

ACTIVE COMPARATOR

Participants reads newspaper before Barlab-Exposure

Behavioral: Reading Newspaper; Behavioral: Barlab-Exposure

Interventions

Trier Social Stress Test BEHAVIORAL

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

Social Stress Test

Reading Newspaper BEHAVIORAL

Participants read newspaper

Control Condition

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.

Control Condition; Social Stress Test

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Central Institute of Mental Health, Mannheim: lead
• Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim: collaborator

Study Sites (1)

Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, Germany

Location

MeSH Terms

Conditions

Alcoholism; Fractures, Stress; Behavior

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Sabine Vollstädt-Klein, Prof. Dr.

  Central Institute of Mental Health, Mannheim

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2018
• First Posted: January 22, 2019
• Study Start: January 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 29, 2024

Record last verified: 2024-03

Locations

DE (1)