Psychobiology of Stress and Alcohol Craving

Central Institute of Mental Health, Mannheim

Status: Completed

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

Treatments: Behavioral: Trier Social Stress Test; Behavioral: Barlab-Exposure; Behavioral: Reading Newspaper

Study type: Interventional

Funder types: Other

Identifiers

NCT03810950

TRR265 A03-Pilot

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 11 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

11 participants in 2 patient groups

Social Stress Test

Experimental group

Description:

Participants undergo the Trier Social Stress Test before Barlab-Exposure

Treatment:

Behavioral: Barlab-Exposure

Behavioral: Trier Social Stress Test

Control Condition

Active Comparator group

Description:

Participants reads newspaper before Barlab-Exposure

Treatment:

Behavioral: Barlab-Exposure

Behavioral: Reading Newspaper