DRY EXTRACT FROM PSILOCYBE CUBENSIS (15-25:1), EXTRACTION SOLVENT: METHANOL for Alcohol use disorder

Inclusion criteria

• {"criterion_text":"- Age of 20-70 years (both included)\n- Body weight of 60-95 kg (both included)\n- Diagnosed with AUD according to DSM-5 criteria and alcohol dependence according to ICD-10\n- Alcohol Use Disorder Identification Test (AUDIT) ≥ 15\n- ≥ 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"}

Exclusion criteria

• {"criterion_text":"- Personal or first-degree relatives with current or previous diagnosis within psychotic spectrum disorders or bipolar disorder.\n- Uncontrolled hypertension (systolic blood pressure >165 mmHg, diastolic blood pressure >95 mmHg).\n- Pharmacotherapy against AUD including disulfiram, naltrexone, acamprosate and nalmefene or treatment with any of these compounds within 28 days prior to inclusion.\n- Treatment with any serotonergic medication or any use of serotonergic psychedelics within 1 month prior to inclusion.\n- 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.\n- Women of childbearing potential who are pregnant, breastfeeding or have intention of becoming pregnant or are not using adequate contraceptive measures considered highly effective.\n- Hypersensitivity to the active substance or to any of the excipients.\n- Only for patients undergoing brain scans: Contraindications for undergoing an fMRI scan (magnetic implants, pacemaker, claustrophobia etc.)\n- Unable to speak and/or understand Danish.\n- Any condition that the investigator feels would interfere with trial participation.\n- History of delirium tremens or alcohol withdrawal seizures.\n- History of suicide attempt or present suicidal ideation.\n- Withdrawal symptoms at inclusion, defined as a score higher than 9 on the Clinical Institute Withdrawal Assessment of Alcohol Scale, Revised (CIWA-Ar).\n- Present or former severe neurological disease including head trauma with loss of consciousness > 30 min.\n- Impaired hepatic function (liver transaminases >3 times upper normal limit).\n- Cardiac problems defined as decompensated heart failure (NYHA class III or IV), unstable angina pectoris and/or myocardial infarction within the last 12 months.\n- Abnormal electrocardiogram\n- mpaired renal function (eGFR < 50 ml/min)."}

Primary endpoints

• {"endpoint_text":"- 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.","definition_or_measurement_approach":"Measured as percentage of heavy drinking days during the last 28 days; heavy drinking day defined as >60 g (men) or >48 g (women). Data registered via Timeline Followback (TLFB)."}

Secondary endpoints

• {"endpoint_text":"- Total alcohol consumption (gram/day) during the last 28 days. Data will be registered via TLFB.\n- Percentage of days without any alcohol consumption during the last 28 days. Data will be registered via TLFB.\n- Penn Alcohol Craving Scale (PACS) score.\n- Alcohol Use Disorders Identification Test (AUDIT) score.\n- Drug Use Disorders Identification Test (DUDIT) score.\n- Alcohol Abstinence Self-efficacy (AASE) score.\n- Quality of life (SF-36) score.\n- Major Depression Inventory (MDI) score.\n- Mindful Attention Awareness Scale (MAAS) score.\n- NEO Personality Inventory score.\n- Acceptance and Action Questionnaire score.\n- Fagerström Test for Nicotine Dependence (FTND) score.\n- Phosphatidyl-ethanol (PEth).\n- Liver parameters gamma-glutamyltransferase (GGT), alanine aminotransferase (ALAT) and mean corpuscular volume (MCV).\n- Brain-derived neurotrophic factor (BDNF).\n- Markers of inflammation (TNF-a and IL-6).\n- Pharmacokinetic properties of plasma psilocin.\n- 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).\n- Changes in emotional response to music as rated by the Geneva Emotional Music Scale (GEMS) and qualitative descriptions obtained by semi-structured interviews.\n- Persisting Effects Questionnaire (PEQ) score\n- Post dosing fMRI analysis including differences in functional connectivity during resting state and task-related activity between treatment groups.","definition_or_measurement_approach":"As specified per endpoint: several endpoints measured via TLFB (total alcohol consumption, % days abstinent), standardized questionnaires/scales for craving and psychiatric measures (PACS, AUDIT, DUDIT, AASE, SF-36, MDI, MAAS, NEO, Acceptance and Action Questionnaire, FTND), biochemical markers/assays for PEth, GGT, ALAT, MCV, BDNF, TNF-α and IL-6; pharmacokinetic analysis for plasma psilocin; acute subjective experience assessed via listed questionnaires (MEQ30, 11D-ASC, EBI, EDI, AES, EM) plus qualitative video/audio analyses; emotional response to music via GEMS and semi-structured interviews; Persisting Effects Questionnaire (PEQ) score; and post-dosing fMRI analyses of functional connectivity and task-related activity."}

Denmark

Earliest CTIS Part Ii Submission Date

02-11-2024

Latest Decision Or Authorization Date

14-11-2024

Processing Time Days

12

Number Of Sites

1

Number Of Participants

100

Primary sponsor

Full Name

Region Hovedstaden

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code 1","organisation_type":"Hospital/Clinic/Other health care facility"}