Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study

• Status: Not yet recruiting
• Trial end date: 2021-05-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this project is to assess the feasibility and safety of administering a single dose of psilocybin to patients diagnosed with alcohol use disorder (AUD). In addition the investigators will establish the pharmacokinetic properties of the active metabolite psilocin. This is the first step in a research project that has the overall aim to evaluate the efficacy of a single administration of psilocybin as an intervention for treatment of 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:

1. Age of 20-70 years (both included).

2. Body weight of 60-95 kg (both included).

3. Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.

4. Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.

5. ≥ 5 heavy drinking days.

Exclusion Criteria:

1. Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.

2. History of delirium tremens or alcohol withdrawal seizures.

3. History of suicide attempt or present suicidal ideation.

4. Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).

5. Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.

6. Impaired hepatic function (liver transaminases > 3 times upper normal limit).

7. Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.

8. Abnormal electrocardiogram

9. Impaired renal function (eGFR < 50 ml/min).

10. Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).

11. Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.

12. Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.

13. Any other active substance use defined as a Drug Use Disorder Identification Test score > 6/2 (m/w) and substance use disorder based on investigator's clinical evaluation, except for nicotine.

14. Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.

15. Hypersensitivity to the active substance or to any of the excipients.

16. Unable to speak and/or understand Danish.

17. Any condition that the investigator feels would interfere with trial participation.