Psychobiology of Stress and Alcohol Craving

NCT ID: NCT03810950

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-01

Study Completion Date

2019-12-31

Brief Summary

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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.

Detailed Description

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The 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.

In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. Here, the investigators aim to identify stress- and alcohol cue-related physiological markers in a lab experiment to assess interactions between acute psychological stress exposure and alcohol cue-exposure regarding their effects on alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity). In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), the investigators will integrate innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance.

Conditions

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Alcohol Use Disorder Stress Reaction Social Stress Craving Behavior

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Social Stress Test

Participants undergo the Trier Social Stress Test before Barlab-Exposure

Group Type EXPERIMENTAL

Trier Social Stress Test

Intervention Type BEHAVIORAL

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

Barlab-Exposure

Intervention Type 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

Participants reads newspaper before Barlab-Exposure

Group Type ACTIVE_COMPARATOR

Reading Newspaper

Intervention Type BEHAVIORAL

Participants read newspaper

Barlab-Exposure

Intervention Type BEHAVIORAL

Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.

Interventions

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Trier Social Stress Test

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

Intervention Type BEHAVIORAL

Reading Newspaper

Participants read newspaper

Intervention Type BEHAVIORAL

Barlab-Exposure

Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim

UNKNOWN

Sponsor Role collaborator

Central Institute of Mental Health, Mannheim

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sabine Vollstädt-Klein, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Central Institute of Mental Health, Mannheim

Locations

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Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit

Mannheim, , Germany

Site Status

Countries

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Germany

Other Identifiers

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TRR265 A03-Pilot

Identifier Type: -

Identifier Source: org_study_id

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