Alcohol Use Disorder MedDRA version: 21.1 Level: LLT Classification code 10001594 Term: Alcohol dependence syndrome System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 21.1 Level: LLT Classification code 10001590 Term: Alcohol addiction System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Product Name: PEX010 (Psilocybin Capsules 25mg)
Product Code: PEX010
Pharmaceutical Form: Capsule
INN or Proposed INN: Dry extract from Psilocybe cubensis (15-25:1), Extraction solvent: methanol
Othe
Sponsors
Psychiatric Centre Copenhagen
Eligibility
Sex/Gender
All
Inclusion 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 defined as alcohol consumption over 60 g of alcohol per day (men) or 48 g of alcohol per day (women) in the past 28 days prior to inclusion, measured by TLFB. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 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 effective. 15. Hypersensitivity to the active substance or to any of the excipients. 16. Only for patients undergoing brain scans: a. Contraindications for undergoing an fMRI scan (magnetic implants, pacemaker, claustrophobia etc.) 17. Unable to speak and/or understand Danish. 18. Any condition that the investigator feels would interfere with trial participation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of this research project is to evaluate the effect of a single administration of the 5-HT2A receptor agonist Psilocybin on heavy drinking days from baseline to follow-up after 12 weeks in patients with alcohol use disorder, in a randomized, double-blinded, placebo-controlled clinical trial. ;Secondary Objective: In addition, we will establish pharmacokinetics of the active metabolite, psilocin. We will explore characteristics of the acute psychedelic experience in relation to treatment outcome as well as possible brain network changes affected by psilocybin by use of brain imaging techniques. ;Primary end point(s): 1.Percentage of heavy drinking days during the last 28 days. A heavy drinking day is defined as a day with an excess intake of 60/48 grams (men/women) of alcohol per day. Data will be registered via TLFB. ;Timepoint(s) of evaluation of this end point: Q3 2024 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 2. Total alcohol consumption (gram/day) during the last 28 days. Data will be registered via TLFB. 3. Percentage of days without any alcohol consumption during the last 28 days. Data will be registered via TLFB. 4. Penn Alcohol Craving Scale (PACS) score. 5. Alcohol Use Disorders Identification Test (AUDIT) score. 6. Drug Use Disorders Identification Test (DUDIT) score. 7. Alcohol Abstinence Self-efficacy (AASE) score. 8. Quality of life (SF-36) score. 9. Major Depression Inventory (MDI) score. 10. Mindful Attention Awareness Scale (MAAS) score. 11. NEO Personality Inventory score. 12. Acceptance and Action Questionnaire score. 13. Fagerström Test for Nicotine Dependence (FTND) score. 14. Phosphatidyl-ethanol (PEth). 15. Liver parameters gamma-glutamyltransferase (GGT), alnine aminotransferase (ALAT) and mean corpuscular volume (MCV). 16. Brain-derived neurotrophic factor (BDNF). 17. Markers of inflammation (TNF-? and IL-6). 18. Pharmacokinetic properties of plasma psilocin. 19. Key phenomena of the acute subjective experience assessed by questionnaires including the Mystical Experience Questionnaire (MEQ30), 11-Dimensional Altered State of Consciousness (11D-ASC)51, Emotional Breakthrough Inventory (EBI), Ego-dissolution Inventory (EDI), The Awe Experience Scale (AES) and the Experience of Music (EM) as well as qualitative analysis of video/audio recordings (before, during and after the psilocybin session). 20. Changes in emotional response to music as rated by the Geneva Emotional Music Scale (GEMS) and qualitative descriptions obtained by semi-structured interviews. 21. Persisting Effects Questionnaire (PEQ) score 22. Post dosing fMRI analysis including differences in functional connectivity during resting state and task-related activity between treatment groups. ;Timepoint(s) of evaluation of this end point: Q3 2024 | — |
Countries
Denmark
Contacts
Public ContactMathias Ebbensen Jensen
Psychiatric Centre Copenhagen
Outcome results
None listed