Stress-related Predictor Profiles in Human Addiction

Alcohol Use Disorder Clinical Trial

Official title:

Stress-related Predictor Profiles for Craving and Relapse in Human Addiction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810924
• Other study ID #: TRR265 A03
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: July 8, 2023

Study information

• Verified date: September 2023
• Source: Central Institute of Mental Health, Mannheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: July 8, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Addiction
• Alcohol Use Disorder
• Alcoholism
• Behavior, Addictive
• Craving
• Fractures, Stress
• Recurrence
• Relapse
• Risk Behavior
• Social Stress
• Stress Reaction

Intervention

Behavioral:
• Trier Social Stress Test
Test to induce high levels of acute social stress, including actors and a faked exam situation
• Ergometer
Riding ergometer
• Barlab-Exposure
Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.
• Reading Newspaper
Participants read newspaper

Locations

Country	Name	City	State
Germany	Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit	Mannheim	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Central Institute of Mental Health, Mannheim	Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	alcohol consumption	self-report using the instrument Form90 (Scheurich et al. 2005)	12 months follow-up