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.