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Intermodal combined PET/MRI examination to measure the activity of the mesolimbic brain system after stress exposure

Intermodal combined PET/MRI examination to measure the activity of the mesolimbic brain system after stress exposure - IMAGe-Stress

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00035839
Enrollment
42
Registered
2025-02-07
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol use disorder Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition - (DSM-5®): codes 305.00 & 303.90

Interventions

Group 1: Sequence group A: Day 1 - stress induction, day 2 - control condition or The study comprises two experimental examinations per participant, which take place 7 days apart. Duration and scop

Sponsors

Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
Lead Sponsor

Eligibility

Sex/Gender
All
Age
30 Years to 50 Years

Inclusion criteria

Inclusion criteria: - Diagnosis of alcohol dependence according to ICD 10 or alcohol use disorder according to DSM-5 and score on the Alcohol Dependence Scale (ADS) < 31 points (i.e. below the range of "very severe dependence") - Abstinence before initial examination of 7 days - Sufficient ability to communicate with the respective study staff, answer questions and complete questionnaires - Written consent available

Exclusion criteria

Exclusion criteria: - Contraindication for a PET or MRI scan - Presence of withdrawal symptoms (CIWA score > 3) at the time of the examination - Breath alcohol > 0.0 per mille at the time of the examination and/or lack of abstinence between the two days of the examination - Presence of an Axis I disorder (DSM-5), except nicotine use disorder, anxiety disorder, remitted affective disorder and mild to moderate depressive episode - Current use of psychotropic medication - Glucocorticoid metabolism disorders, use of glucocorticoid-containing medications or medications that interact with glucocorticoids - For female participants: Pregnancy or planned pregnancy - Participation in a study with ionising radiation within the last 5 years - Presence of acute suicidal behaviour or acute danger to self or others - Current use of illegal substances, opiates or sedatives

Design outcomes

Primary

MeasureTime frame
Changes in striatal [18F]desmethoxyfallypride binding potential and BOLD signal changes in fMRI after stress induction compared to control condition

Secondary

MeasureTime frame
Cortisol levels as well as levels of other biomarkers such as cortisone, testosterone, androstenedione, progesterone, endocannabinoids (2-AG, AEA, OEA, PEA) and ethyl glucuronide (Etg), alcohol craving and risk of relapse

Countries

Germany

Contacts

Public ContactPatrick Bach

Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin

patrick.bach@zi-mannheim.de0621 / 1703-0

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026