Status:
ACTIVE_NOT_RECRUITING
Psilocybin for Treatment of Alcohol Use Disorder: a Feasibility Study
Lead Sponsor:
Anders Fink-Jensen, MD, DMSci
Collaborating Sponsors:
The Neurobiology Research Unit at Copenhagen University Hospital Rigshospitalet
Conditions:
Alcohol Use Disorder (AUD)
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
Brief 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 wi...
Detailed Description
The investigators will evaluate the feasibility and safety of administering psilocybin to 10 patients diagnosed with AUD. Following informed consent, patients will be screened for eligibility as per i...
Eligibility Criteria
Inclusion
- Age of 20-70 years (both included).
- Body weight of 60-95 kg (both included).
- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10.
- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15.
- ≥ 5 heavy drinking days.
Exclusion
- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.
- History of delirium tremens or alcohol withdrawal seizures.
- History of suicide attempt or present suicidal ideation.
- Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).
- Present or former severe neurological disease including head trauma with loss of consciousness \> 30 min.
- Impaired hepatic function (liver transaminases \> 3 times upper normal limit).
- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.
- Abnormal electrocardiogram
- Impaired renal function (eGFR \< 50 ml/min).
- Uncontrolled hypertension (systolic blood pressure \>165 mmHg, diastolic blood pressure \>95 mmHg).
- Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.
- Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.
- 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.
- Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective61.
- Hypersensitivity to the active substance or to any of the excipients.
- Unable to speak and/or understand Danish.
- Any condition that the investigator feels would interfere with trial participation.
Key Trial Info
Start Date :
February 9 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 21 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04718792
Start Date
February 9 2023
End Date
July 21 2024
Last Update
July 12 2024
Active Locations (1)
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1
Psychiatric Center Copenhagen
Copenhagen, Frederiksberg, Denmark, 2000