Ignite Creation Date:
2025-12-24 @ 7:10 PM
Ignite Modification Date:
2026-01-23 @ 3:39 PM
Study NCT ID:
NCT05646303
Status:
UNKNOWN
Last Update Posted:
2024-08-15
First Post:
2022-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011562', 'term': 'Psilocybin'}], 'ancestors': [{'id': 'D026121', 'term': 'Indole Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D014363', 'term': 'Tryptamines'}, {'id': 'D054836', 'term': 'Indolizidines'}, {'id': 'D007212', 'term': 'Indolizines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-14', 'studyFirstSubmitDate': '2022-12-02', 'studyFirstSubmitQcDate': '2022-12-02', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Reduction in the number of Heavy Drinking Days', 'timeFrame': '8 weeks', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to investigate treatment with psilocybin and psychotherapy for the treatment of people with Alcohol Use Disorder (AUD). The main question\\[s\\] it aims to answer are:\n\n* Does treatment with psilocybin and therapy help reduce alcohol consumption more than placebo and therapy?\n* Is treatment with psilocybin and therapy safe for participants?\n\nParticipants will\n\n* Attend 13 study visits\n* Take part in therapy sessions including 2 treatment sessions with either psilocybin or placebo\n* Record their daily alcohol consumption on study specific device\n\nResearchers will compare psilocybin and placebo groups to see if alcohol consumption is decreased.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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.\n* Expressed a wish to reduce or stop alcohol consumption.\n* Generally healthy with no unstable medical conditions, as determined by medical history, physical examination, routine blood labs, electrocardiogram, urine analysis, and urine toxicology.\n\nExclusion Criteria:\n\n* 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 episode. Recent (within last 12 months) diagnosis of a major depressive disorder (MDD) (HAM-D score \\>19), treatment resistant depression (TRD), post-traumatic stress disorder (PTSD), panic disorder, or eating disorders.\n* Subjects deemed unfit for psilocybin-assisted therapy based on the assessments made during psychotherapy sessions prior to the first psilocybin-assisted psychotherapy session.\n* History of hallucinogen use disorder, or any use in the past 1 year, or \\>25 lifetime uses.'}, 'identificationModule': {'nctId': 'NCT05646303', 'briefTitle': 'Psilocybin-Assisted Psychotherapy in Adults With Alcohol Use Disorder (AUD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clairvoyant Therapeutics'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'CLA PSY 201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Psilocybin', 'description': '2 oral doses of 25mg psilocybin capsules', 'interventionNames': ['Drug: Psilocybin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '2 oral doses of placebo (microcrystalline cellulose) capsules', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'description': 'Psilocybin and psychotherapy', 'armGroupLabels': ['Psilocybin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo and psychotherapy', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T3C 0J7', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Sabi Mind', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'city': 'Kelowna', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Okanagan Clinical Trials', 'geoPoint': {'lat': 49.88307, 'lon': -119.48568}}, {'city': 'Surrey', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'Centre for Neurology Studies', 'geoPoint': {'lat': 49.10635, 'lon': -122.82509}}, {'zip': 'V6T 1Z3', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': 'University of British Columbia, Department of Psychiatry, BRAIN Lab', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}, {'zip': 'B3S 1N2', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'Centricity Research', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}, {'zip': 'L8S 1B7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': 'MacAnxiety Research Centre', 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}, {'city': 'Kingston', 'state': 'Ontario', 'country': 'Canada', 'facility': "Department of Psychiatry, Queen's University", 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'M6J 1H4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'city': 'Helsinki', 'country': 'Finland', 'facility': 'Research Center Oxidi Oy / Addiktum Oy', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '45100', 'city': 'Kouvola', 'country': 'Finland', 'facility': 'A-Klinikka', 'geoPoint': {'lat': 60.86667, 'lon': 26.7}}, {'city': 'Oulu', 'country': 'Finland', 'facility': 'Mentacare Oy', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'city': 'Turku', 'country': 'Finland', 'facility': 'Addiktum Oy', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}], 'overallOfficials': [{'name': 'Hannu Alho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Addiktum Oy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clairvoyant Therapeutics', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Optimapharm', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}