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    EudraCT Number:2021-006200-33
    Sponsor's Protocol Code Number:CLA-PSY-201
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-06-27
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedFinland - Fimea
    A.2EudraCT number2021-006200-33
    A.3Full title of the trial
    A 24-Week, Multicentre, Randomised, Double-Blind,
    Placebo-Controlled, Parallel-Group, Phase 2 Clinical Trial to
    Evaluate Efficacy and Safety of Psilocybin-Assisted
    Psychotherapy in Adults with Alcohol Use Disorder (AUD)
    24 viikkoa kestävä satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, rinnakkaisryhmissä tehtävä vaiheen 2
    kliininen monikeskustutkimus, jossa arvioidaan psilosybiiniavusteisen psykoterapian tehokkuutta ja turvallisuutta
    aikuisilla, joilla on alkoholinkäytön häiriö (AUD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Trial to Evaluate Efficacy and Safety of Psilocybin-Assisted
    Psychotherapy in Adults with Alcohol Use Disorder (AUD)
    Kliininen tutkimus, jossa arvioidaan psilosybiiniavusteisen psykoterapian tehokkuutta ja turvallisuutta aikuisilla, joilla on alkoholinkäytön häiriö (AUD)
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberCLA-PSY-201
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT05646303
    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 SponsorClairvoyant Therapeutics Inc.
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportClairvoyant Therapeutics Inc.
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClairvoyant Therapeutics Inc.
    B.5.2Functional name of contact pointPSY-CLA Study Contact
    B.5.3 Address:
    B.5.3.1Street Address2400-1055 W. Georgia St.
    B.5.3.2Town/ cityVancouver, BC
    B.5.3.3Post codeV6E 3P3
    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 namePsilocybin capsule 25 mg
    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 INNPsilocybine
    D.3.9.1CAS number 520-52-5
    D.3.9.4EV Substance CodeSUB10158MIG
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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 No
    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 (AUD)
    E.1.1.1Medical condition in easily understood language
    Alcohol use disorder (AUD)
    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 20.1
    E.1.2Level PT
    E.1.2Classification code 10080021
    E.1.2Term Alcohol use disorder
    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 primary objective of the trial is to evaluate the efficacy of 25 mg Psilocybin vs Placebo in subjects with alcohol use disorder (AUD) with number of heavy drinking days (HDD) over the 8-week treatment period, measured on a monthly basis relative to baseline (Visit 1 - 5).
    E.2.2Secondary objectives of the trial
    The secondary objectives of this trial are to assess the effects of 25 mg psilocybin vs placebo on the following endpoints:
    • Monthly number of HDD at V5(baseline), Week 4, 8, 12, 16, 20, and 24.
    • Monthly total alcohol consumption (TAC), defined as the mean daily alcohol consumption expressed in g/day at V5 (baseline), Week 4, 8, 12, 16, 20 and 24.
    • Proportion of subjects with no HDD per month at Week 8, 12, 16, 20, and 24.
    • Proportion of subjects with one- or two-level reductions in the WHO Risk Drinking Levels per month at Week 8 and 12.
    • DSM-5 score at V1 vs V13 (Week 24)
    Safety as measured by
    • The incidence and severity of adverse events (AEs) treatment emergent adverse events (TEAEs), serious adverse events (SAEs) and the number of subjects withdrawn from the trial due to a TEAE.
    • Clinical safety parameters including physical examination, body weight, vital signs, and clinical laboratory investigations.
    • Psychedelic experience during the psychotherapy sessions.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Moderate to severe diagnosis of AUD as measured by Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) criteria using Structured Clinical Interview for DSM-5 by the investigator.

    • A subject is eligible for participation in the trial if he/she/they (sex at birth) had:
    a. ≥6 HDDs (defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females) in a 4-week period prior to V1 (TLFB) OR an average alcohol consumption of >40 g of ethanol/day for males and >20 g of alcohol/day for females for a 4-week period prior to V1 (TLFB), [minimum of the medium risk level as defined by the WHO "International therapist for monitoring alcohol consumption and related harm."]
    b. ≥6 HDDs (defined as a day with alcohol consumption of 60 g or more for males and 40 g or more for females) in a 4-week period prior to V5 (e-diary),

    • Expressed a wish to reduce or stop alcohol consumption.

    • Able to provide alcohol consumption information for the 4-week period prior to V1.

    • Willingness to participate in behavioural and medicinal treatments for AUD.

    • Subjects of childbearing potential must be using a highly effective, established method of contraception for the entire trial duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices.
    Note: Subjects identified female-at-birth who are surgically sterilised (bilateral salpingectomy, or bilateral oophorectomy)/hysterectomised at least 3 months before V1 or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
    Male subjects who engage in sex that could result in pregnancy should use condom with spermicide throughout their trial participation in addition to the use of a highly effective contraceptive method by any partner of childbearing potential.

    • Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.
    E.4Principal exclusion criteria
    • Withdrawal symptoms requiring additional medication defined as a score higher than 8 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).

    • Diagnosed with or having a family history of any of the following concomitant psychiatric disorders: schizophrenia or prodromal symptoms, any bipolar disorder, obsessive compulsive disorder, or other psychotic disorder. Recent (within last 12 months) diagnosis of a major depressive episode (MDD) (as according to Hamilton Depression Scale, HAM-D, score >19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder or eating disorders.
    Note: Subjects with nicotine use disorder, phobic, or other anxiety disorders (other than post-traumatic stress disorder or panic disorder) can be included.

    • Current or recent (within 6 weeks prior to V1) treatment with antipsychotic or antidepressant medications, which can influence serotonin receptor or transporter actions.

    • History of hallucinogen use disorder, or any use in the past 1 year, or >25 lifetime uses.

    • Currently participating or has recently (4 weeks prior to V1) participated in a treatment program for AUD.

    • Clinically significant untreated or unstable illness as defined by
    a. Hepatic function:
    • Aspartate aminotransferase (AST) >3x the upper limit of normal (ULN) or
    •Alanine aminotransferase (ALT) >3x the upper limit of normal (ULN) or
    • Total bilirubin >2x ULN
    • Prolonged prothrombin time (PTT) INR ≥1.7
    b. Renal function:
    • Reduced estimated glomerular filtration rate (eGFR) <50 mL/min/1.73 m2.
    c. Cardiovascular functions:
    • History or current evidence of a clinically significant cardiovascular disease, including myocardial infarction, cerebrovascular accident, unstable angina, New York Heart Association Class II or greater heart failure, severe cardiac arrhythmia requiring medication or implanted defibrillator or pacemaker, syncope.
    •Uncontrolled hypertension, defined by systolic blood pressure >150 mmHg and/or diastolic blood pressure >90 mmHg (measured while subject is lying supine over a 5-minute duration. If necessary, these assessments will involve three readings separated by 5 minutes) with or without antihypertensive medications; or clinically significant hypotension.
    • Finding of any of the following on the V1 ECG: QT interval corrected using Fridericia’s formula (QTcF) >450 msec (males) and >470 msec (females), frequent supraventricular or ventricular ectopy, complete right and left bundle branch block (QRS >110 ms), or any other ECG findings that, in the opinion of the Investigator is regarded as abnormal.

    • Allergy, hypersensitivity, or other adverse reaction to previous use of psilocybin, other hallucinogens, rescue medications and their excipients or microcrystalline cellulose.

    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint for analysis of efficacy is defined as
    • Mean number of HDD from V5 (baseline) measured monthly (4 weeks) over the treatment period
    (Week 8), where heavy drinking is defined as the consumption of ≥60 g alcohol/day (if male) or
    ≥40 g alcohol/day (if female).
    E.5.1.1Timepoint(s) of evaluation of this end point
    From V5 (baseline) measured monthly (4 weeks) over the treatment period (Week 8)
    E.5.2Secondary end point(s)
    The secondary endpoints of this trial are the following:
    • Change from V5 in the monthly (4 weeks) number of HDD at Week 4, 8, 12, 16, 20, and 24.
    • Change from V5 in monthly TAC up to Week 24.
    • Proportion of subjects with no HDD per month at Week 8, 12, 16, 20, and 24.
    • Proportion of subjects with one- or two-level reductions in the WHO Risk Drinking Levels up to Week 24.
    • Proportion of subjects whose DSM-5 score has improved between V1 and V13 (Week 24).

    Safety endpoints:
    • The incidence and severity of AEs, TEAEs, SAEs, and the number of subjects withdrawn from
    the trial due to a TEAE.
    • Clinical safety parameters based on physical examination, body weight, vital signs, and clinical
    • Psychedelic experience during the psychotherapy sessions as measured by the 5-Dimensional
    Altered States of Consciousness Scale (5D-ASCS), Mystical Experience Questionnaire (MEQ), and
    Therapy Evaluation Form.

    E.5.2.1Timepoint(s) of evaluation of this end point
    • HDD: at V5, week 4, 8, 12, 16, 20, and 24.
    • TAC: at V5, Week 4, 8, 12, 16, 20, and 24.
    • HDD per month: at Week 8, 12, 16, 20, and 24
    • WHO Risk Drinking Levels per month: up to Week 24
    • DSM-5 score: V1, V13 (Week 24)
    • Physical examination: V1, V5, V10.
    • Body weight: V1, V10.
    • Vital signs: V1, V5-V10.
    • Clinical laboratory: V1, V5, V10.
    • 5D-ASCS, Mystical Experience Questionnaire, and Therapy Evaluation Form: V6, V8.

    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 No
    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. 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 Yes
    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 No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months5
    E.8.9.2In all countries concerned by the trial days0
    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: 150
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 100
    F.4.2.2In the whole clinical trial 160
    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)
    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 Decision2022-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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