Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

Inclusion Criteria: * Bodyweight of 50-110 kg * AUD according to DSM-5 criteria and alcohol dependence according to ICD-10. * AUD Identification Test (AUDIT) ≥ 15. * ≥ 5 heavy drinking days in the past 28 days prior to inclusion. Exclusion Criteria: * Current or previously diagnosed with any psychotic disorder or bipolar affective disorder. * Immediate family member with a diagnosed psychotic disorder. * History of delirium tremens or alcohol withdrawal seizures. * History of suicide attempt or present suicidal ideation at screening. * Withdrawal symptoms at screening (\>nine on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar) (43). * Present or former severe neurological disease including trauma with loss of consciousness \> 30 min. * Impaired hepatic function (alanine transaminase \>210/135 units/l men/women) * Cardiovascular disease defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris, myocardial infarction within the last 12 months or uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg). * Present or former abnormal QTc (\>450/470 ms men/women). * Treatment with disulfiram, naltrexone, acamprosate and nalmefene within 28 days of inclusion. * Treatment with any serotonergic medication or drugs within one month prior inclusion. * Any oOther active substance use disorders (except nicotine) defined as a Drug Use Disorder Identification Test score \>six/two (men/women) and investigator's clinical evaluation. * Women who are pregnant, breastfeeding, or intend to become pregnant or are not using adequate contraceptive measures considered highly effective (44). * Unable to speak or understand Danish. * Any other condition that the clinician estimates can interfere with trial participation.