DSM-5: Alcohol User Disorder/Alcohol Dependence
Conditions
Interventions
Group 1: Arm 1: Intervention group:
Combined stress and alcohol cue exposure followed by the assessment of neural alcohol cue-reactivity using functional magnetic resonance imaging (fMRI) after antag
Sponsors
Zentralinstitut für Seelische Gesundheit Mannheim
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Individuals with insomnia > 3 months according to the ICD-10 (i.e. indication for receiving daridorexant as part of clinical routine practice) and that use alcohol regularly and meet definition of the research diagnosis of an alcohol use disorder (AUD) according to DSM-5 (i.e. that meet 2 or more DSM-5 criteria of AUD). Participants will be screened and enrolled during routine clinical treatment at the Central Institute of Mental Health (independent of study). Inclusion Criteria - Age between 18 and 65 years - Participants diagnosed with insomnia according to the ICD-10 - Regular alcohol use (>2/week & >=2 of 11 criteria of an alcohol use disorder according to DSM-5) - Ability of the individual to understand the character and the individual consequences of the study - Written informed consent (must be available before enrollment in the study) - Consent to random assignment
Exclusion criteria
Exclusion criteria: - Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations - Contraindication for functional magnetic resonance imaging (e.g. metal implants) - Pregnancy, lactation or breastfeeding - Current severe somatic comorbidities: liver cirrhosis, severe liver dysfunction (Child Pugh Score: = 7) or severely impaired renal function, severe heart insufficiency, pre-existing epilepsy, narcolepsy - History of hypersensitivity to Daridorexant (Idorsia®) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of Daridorexant (Idorsia®) - Any withdrawal symptoms at the time of the study visit (CIWA score >3) - Breath alcohol concentration > 0.0 at the time of the study visit - Positive drug screening (amphetamines/ecstasy, opiates, cocaine, barbiturates, cannabis, benzodiazepines) - Current treatment with daridorexant or other orexin receptor antagonists or use of these drugs within the last 7 days - Simultaneous use of strong CYP3A4 inhibitors (e.g. erythromycin, ciprofloxacin, cyclosporine) - Acute suicidal tendency or acute endangerment of self and others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint To assess the effects of the antagonistic modulation of Orexin 1 (OrxR1) and Orexin 2 (OrxR2) receptors by the dual orexin antagonist (DORA) Daridorexant (DRX) on neural alcohol cue-reactivity in the Nucleus accumbens (primary outcome), measured using the blood oxygenated level dependent (BOLD) response, during presentation of alcohol cues. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: • To assess the effects of the antagonistic modulation of Orexin 1 (OrxR1) and Orexin 2 (OrxR2) receptors by the dual orexin antagonist (DORA) Daridorexant (DRX) on neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during the presentation of emotional faces and neutral shapes. • To assess the effects of the antagonistic modulation of Orexin 1 (OrxR1) and Orexin 2 (OrxR2) receptors by the dual orexin antagonist (DORA) Daridorexant (DRX) on neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during inhibition of motor responses. • To assess the effects of the antagonistic modulation of Orexin 1 (OrxR1) and Orexin 2 (OrxR2) receptors by the dual orexin antagonist (DORA) Daridorexant (DRX) on neural brain activation, measured using the blood oxygenated level dependent (BOLD) response, during the presentation of natural reward cues (e.g. food). | — |
Countries
Germany
Contacts
Public ContactPatrick Bach
Zentralinstitut für Seelische Gesundheit Mannheim
Outcome results
None listed