Stress-related Predictor Profiles in Human Addiction

Central Institute of Mental Health, Mannheim

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03810924

TRR265 A03

Details and patient eligibility

About

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.

Full description

In patients with Alcohol Use Disorder (AUD) stress exposure is known to affect craving, cue-reactivity and relapse risk. 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 (1) alcohol craving and related markers (attentional bias to alcohol-cues, implicit association task, neural cue-reactivity), (2) their predictive capacity for future alcohol intake, (3) the identification their neural correlates in brain circuits of motivational, cognitive, and affective processing. In addition to applying established stress-related markers (cortisol in saliva, heart-rate variability, systolic blood pressure and electrodermal activity), (4) we will integrate portable sensors (wearables) to allow a future integration in ambulatory assessments and to test innovative measures currently under investigation (e.g. voice stress analysis) to identify whether these additional parameters increase the predictive significance. Our 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.

Enrollment: 121 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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121 participants in 3 patient groups

Control

Active Comparator group

Description:

Participants reads newspaper before Barlab-Exposure

Treatment:

Behavioral: Barlab-Exposure

Behavioral: Reading Newspaper

Experimental 1 (Distress)

Experimental group

Description:

Participants undergo the Trier Social Stress Test before Barlab-Exposure

Treatment:

Behavioral: Barlab-Exposure

Behavioral: Trier Social Stress Test

Experimental 2 (Eustress)

Experimental group

Description:

Participants ride an ergometer before Barlab-Exposure

Treatment:

Behavioral: Ergometer

Behavioral: Barlab-Exposure