Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-25 @ 8:35 PM
Study NCT ID:
NCT05995769
Status:
RECRUITING
Last Update Posted:
2024-05-07
First Post:
2023-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder
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': 'RECRUITING', 'startDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-06', 'studyFirstSubmitDate': '2023-08-09', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Heavy drinking', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'Percent heavy drinking days (TLFB)'}], 'secondaryOutcomes': [{'measure': 'Abstinence', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'Days abstinent (TLFB)'}, {'measure': 'Biomarkers of alcohol consumption', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'Phosphatidylethanol (Peth)'}, {'measure': 'Alcohol cue reactivity', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'Alcohol urge questionnaire (AUQ)'}, {'measure': 'Cognitive flexibility', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'Berg Card Sorting Task'}, {'measure': 'Depression', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'The Montgomery-Åsberg Depression Rating Scale (MADRS)'}, {'measure': 'Anxiety', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'The General Anxiety Disorder 7 (GAD-7) scale'}, {'measure': 'Quality of life', 'timeFrame': 'Change from baseline to 1-, 4-, and 12-weeks post-dosing', 'description': 'The World Health Organization Quality of Life (WHOQOL) scale'}, {'measure': 'Glutamate levels', 'timeFrame': 'Change from baseline to 1-week post-dosing', 'description': 'MR spectroscopy of glutamate levels in the anterior cingulate cortex'}, {'measure': 'GABA levels', 'timeFrame': 'Change from baseline to 1-week post-dosing', 'description': 'MR spectroscopy of GABA levels in the anterior cingulate cortex'}, {'measure': 'Resting state functional connectivity', 'timeFrame': 'Change from baseline to 1-week post-dosing'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder', 'Alcoholism']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine if a single dose of psilocybin administered with motivational enhancement therapy (MET) can reduce heavy drinking in patients with an alcohol use disorder (AUD).', 'detailedDescription': 'The primary objective of this study is to determine if psilocybin administered with a standardized psychotherapeutic intervention, motivational enhancement therapy (MET), can reduce heavy drinking in a patient population with an alcohol use disorder (AUD). Patients with an AUD will be randomly allocated to either a high dose (25mg; active treatment) or a low dose (1mg; active control) psilocybin arm. All participants will receive 5 sessions of MET, starting at 24hrs post-dosing. Heavy drinking will be assessed as percent heavy drinking days using the Time Line Follow Back (TLFB) at baseline and 1-, 4-, and 12-weeks post-dosing.\n\nA total of 128 male and female patients between the ages of 22-65 with a moderate to severe AUD diagnosis will be recruited from the community. Participants will undergo a thorough screening procedure and eligible participants will be randomly allocated to the high (N=64) or low (N=64) psilocybin doses. All participants will complete a baseline session consisting of clinical, behavioral, and neuroimaging measures. Following the single dosing session, participants will complete 5 weekly MET sessions. Neuroimaging measures will be assessed again at 1-week post-doing. Clinical and behavioral outcomes will be measured at 1-, 4-, and 12-weeks post-dosing'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets DSM-5 AUD criteria of at least moderate severity\n* Meets heavy drinking requirements (heavy drinking days, number of drinks) in past 30 days\n* Desire to decrease alcohol consumption\n* Limited lifetime hallucinogen use\n\nExclusion Criteria:\n\n* Severe or moderate substance use disorder other than alcohol or nicotine in past 6 months\n* Diagnosis of schizophrenia, bipolar disorders or first-degree relative with diagnosis\n* Active suicidal ideation or serious attempt within past 3 years\n* Currently pregnant, nursing, or trying to become pregnant\n* Any notable abnormality on ECG, physical exam, or routine medical blood laboratory test'}, 'identificationModule': {'nctId': 'NCT05995769', 'acronym': 'PAP-AUD', 'briefTitle': 'Psilocybin-Assisted Psychotherapy for Alcohol Use Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'Mechanisms Supporting Psilocybin-assisted Psychotherapy for Alcohol Use Disorder: A Randomized, Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'REB23-0666'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Dose (25mg)', 'description': 'PEX010 (Oral Psilocybin), 25mg; single dose administered 24hrs prior to first of 5 weekly MET sessions', 'interventionNames': ['Drug: Psilocybin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low dose (1mg)', 'description': 'PEX010 (Oral Psilocybin), 1mg; single dose administered 24hrs prior to first of 5 weekly MET sessions', 'interventionNames': ['Drug: Psilocybin']}], 'interventions': [{'name': 'Psilocybin', 'type': 'DRUG', 'otherNames': ['magic mushrooms', 'PEX010'], 'description': 'Single dosing session followed by 5 MET weekly sessions starting 24hrs after dosing', 'armGroupLabels': ['High Dose (25mg)', 'Low dose (1mg)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'status': 'RECRUITING', 'country': 'Canada', 'facility': 'University of Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'centralContacts': [{'name': "Kaitlin O'Grady", 'role': 'CONTACT', 'email': 'pactlab@ucalgary.ca', 'phone': '587-893-0257'}], 'overallOfficials': [{'name': 'Leah Mayo, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Calgary'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johns Hopkins University', 'class': 'OTHER'}, {'name': 'University of Maryland', 'class': 'OTHER'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}