Stress-related Predictor Profiles in Human Addiction

NCT03810924 | Completed

• 1 other identifier: TRR265 A03
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Use Disorder; Stress Reaction; Social Stress; Craving; Relapse; Addiction; Risk Behavior

Outcome Measures

Primary Outcomes (15)

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

• fMRI

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

  self-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

Secondary Outcomes (1)

• alcohol consumption

  12 months follow-up

Study Arms (3)

Control

ACTIVE COMPARATOR

Participants reads newspaper before Barlab-Exposure

Behavioral: Barlab-Exposure; Behavioral: Reading Newspaper

Experimental 1 (Distress)

EXPERIMENTAL

Participants undergo the Trier Social Stress Test before Barlab-Exposure

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

Experimental 2 (Eustress)

EXPERIMENTAL

Participants ride an ergometer before Barlab-Exposure

Behavioral: Ergometer; 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

Experimental 1 (Distress)

Ergometer BEHAVIORAL

Riding ergometer

Experimental 2 (Eustress)

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; Experimental 1 (Distress); Experimental 2 (Eustress)

Reading Newspaper BEHAVIORAL

Participants read newspaper

Control

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

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, Baden-Wurttemberg, 68159, Germany

Location

MeSH Terms

Conditions

Alcoholism; Fractures, Stress; Recurrence; Behavior, Addictive; Risk-Taking

Interventions

Psychological Tests

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Fractures, Bone; Wounds and Injuries; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Officials

• Falk Kiefer, Prof.

  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: July 1, 2019
• Primary Completion: September 30, 2022
• Study Completion: July 8, 2023
• Last Updated: September 15, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)