Alcohol Use Disorder (DSM-5)
Conditions
Interventions
Group 1: 800mg/day, Cannabidiol, p.o., single dose
Group 2: Placebo, p.o., single dose
Sponsors
Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: - Age between 18 and 60 years - Participants meeting the diagnosis of an alcohol use disorder according to the DSM-V - 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: - Subjects presenting with any of the following criteria will not be included in the study: Current psychotic or bipolar disorder or current severe depressive episode with suicidal ideations - Contraindication for functional magnetic resonance imaging (e.g. metal implants) - 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) - Pregnancy, lactation or breastfeeding - Current severe somatic comorbidities: liver cirrhosis or severely impaired renal function, severe heart insufficiency, pre-existing epilepsy - History of hypersensitivity to Cannabidiol (Arvisol®) or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of Arvisol® - Acute suicidal tendency or acute endangerment of self and others
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neural alcohol cue-reactivity in the nucleus accumbens 280 minutes after CBD administration | — |
Secondary
| Measure | Time frame |
|---|---|
| Alcohol craving | — |
Countries
Germany
Contacts
Public ContactPatrick Bach
Zentralinstitut für Seelische Gesundheit Klinik für Abhängiges Verhalten und Suchtmedizin
Outcome results
None listed