Psilocybin-assisted Therapy for Treatment of Alcohol Use Disorder

• Status: Not yet recruiting
• Trial end date: 2025-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this project is to assess the treatment efficacy of a single high dose of psilocybin administered within a protocol of psychological support to patients diagnosed with alcohol use disorder (AUD).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Anders Fink-Jensen, MD, DMSci
• Collaborator: The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
• Treatments: Psilocybin

Criteria

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.