Status:
COMPLETED
Stress-related Predictor Profiles in Human Addiction
Lead Sponsor:
Central Institute of Mental Health, Mannheim
Collaborating Sponsors:
Project Group for Automation in Medicine and Biotechnology PAMB, Mannheim
Conditions:
Alcohol Use Disorder
Stress Reaction
Eligibility:
All Genders
18-65 years
Phase:
NA
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...
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 8 2023
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT03810924
Start Date
July 1 2019
End Date
July 8 2023
Last Update
September 15 2023
Active Locations (1)
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1
Klinik für Abhängiges Verhalten, Zentralinstitut für Seelische Gesundheit
Mannheim, Baden-Wurttemberg, Germany, 68159