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    Summary
    EudraCT Number:2020-000829-55
    Sponsor's Protocol Code Number:PSILO4ALCO
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-10-27
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2020-000829-55
    A.3Full title of the trial
    Can a one-off administration of psilocybin reduce alcohol intake in patients with alcohol use disorder? A randomized, double-blinded, placebo-controlled clinical trial.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Can a single dose of psilocybin reduce alcohol intake in patients with alcohol use disorder?
    A.4.1Sponsor's protocol code numberPSILO4ALCO
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorPsychiatric Centre Copenhagen
    B.1.3.4CountryDenmark
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportThe Novo Nordic Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Lundbeck Foundation
    B.4.2CountryDenmark
    B.4.1Name of organisation providing supportThe Ivan Nielsen Foundation
    B.4.2CountryDenmark
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPsychiatric Centre Copenhagen
    B.5.2Functional name of contact pointMathias Ebbensen Jensen
    B.5.3 Address:
    B.5.3.1Street AddressHovedvejen 17
    B.5.3.2Town/ cityFrederiksberg
    B.5.3.3Post code2000
    B.5.3.4CountryDenmark
    B.5.6E-mailmathias.ebbesen.jensen.01@regionh.dk
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namePEX010 (Psilocybin Capsules 25mg)
    D.3.2Product code PEX010
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDry extract from Psilocybe cubensis (15-25:1), Extraction solvent: methanol
    D.3.9.3Other descriptive namePYEX
    D.3.9.4EV Substance CodeSUB267722
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alcohol Use Disorder
    E.1.1.1Medical condition in easily understood language
    Alcohol dependence
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10001594
    E.1.2Term Alcohol dependence syndrome
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10001590
    E.1.2Term Alcohol addiction
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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.
    E.4Principal 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 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.
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q3 2024
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Q3 2024
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 100
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    None
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-12-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusOngoing
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