[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550220":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":26,"responsibleParty":45,"collaborators":47,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":26,"eligibilityCriteria":57,"healthyVolunteers":53,"sex":58,"minAge":59,"maxAge":26,"enrollmentInfo":60,"targetDuration":26,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":72,"overallStatus":77,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":26},{"fullName":5,"class":6},"University of Sydney","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Psilocybin + Therapy","EXPERIMENTAL","* 12 weekly sessions of psychotherapy for AUD\n* 2 dosing sessions - psilocybin 25mg\n* Additional open-label dosing session for participants in control arm post-follow up\n* 2 integration sessions following each dosing session (additional dosing session for open label dosing)\n* 3 post-treatment follow-up sessions\n* Total of 13 clinic sessions",[13],"Drug: Psilocybin",{"label":15,"type":16,"description":17,"interventionNames":18},"Niacin + Therapy","PLACEBO_COMPARATOR","* 12 weekly sessions of psychotherapy for AUD\n* 2 dosing sessions - niacin 250mg\n* 2 integration sessions following each dosing session\n* 3 post-treatment follow-up sessions\n* Total of 13 clinic sessions",[19],"Drug: Niacin",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Psilocybin","Psilocybin is a naturally occurring psychedelic prodrug compound produced by more than 200 species of fungi.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Niacin","A nutrient in the vitamin B complex that the body needs in small amounts to function and stay healthy. Niacin helps some enzymes work properly and helps skin, nerves, and the digestive tract stay healthy. Niacin is found in many plant and animal products.\n\nNiacin will be used at a concentration of 250mg as an active control.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Paul Haber, PhD","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":34},"Kirsten C Morley, PhD",[38,43],{"name":36,"role":39,"phone":40,"phoneExt":41,"email":42},"CONTACT","95153636","612","Kirsten.morley@sydney.edu.au",{"name":33,"role":39,"phone":26,"phoneExt":26,"email":44},"paul.haber@sydney.edu.au",{"type":46,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[48],{"name":49,"class":50},"Woke Pharmaceuticals","UNKNOWN","100550220","phase-2-psilocybin-assisted-therapy-for-alcohol-use-disorder-100550220",false,"NCT06444243","Psilocybin-assisted Therapy for Alcohol Use Disorder","A Multi-centre, Double-blinded, Placebo-controlled, Randomised, Phase II Clinical Trial for Psilocybin-assisted Therapy for Alcohol Use Disorder","Inclusion Criteria:\n\n1. Moderate to severe AUD according to the DSM-5 criteria\n2. A desire to reduce or stop drinking\n3. Consumed at least 21 standard drinks per week or ≥2 HDD (≥5 standard drinks\u002Fday for men; ≥4 for women) in the past week prior to screening\n4. Aged ≥18 years old\n5. Adequate cognition and English language skills to give valid consent and complete research interviews and assessments (MoCA ≥26)\n6. Received prior treatment for AUD (not including study interventions)\n7. Stable housing within reasonable distance to a clinical site for the duration of the study\n8. Able to identify a significant other (such as a family\u002Ffriend\u002Fpartner) who could accompany them from clinic\u002Fprovide transport and\u002For be contacted by the study team if required\n9. Willing to give written informed consent\n\nExclusion Criteria:\n\n* a. History of or currently meeting DSM-5 criteria for:\n\n  * Any psychotic disorder\n  * Bipolar disorder type 1 or 2\n  * Major depression with psychotic features\n  * Any personality disorders\n  * Post-traumatic stress disorder\n  * Hallucinogen persisting perception disorder b. A family history of:\n  * Schizophrenia or schizoaffective disorder (first- or second-degree relatives), or\n  * Bipolar disorder type 1 (first degree relatives) c. Suicide risk according to clinician judgement (e.g. previous suicide attempt or self-harm in the past 6 months) and responses to Columbia Suicide Severity Rating Scale (C-SSRS) and SCID-5-RV.\n\n    d. Abnormal and\u002For serious clinical finding or medical condition that may preclude participation e. Concurrent use of psychotropic medication e.g., antidepressants, antipsychotics, psychostimulants, treatments for addictions, other dopaminergic or serotonergic agents (e.g. St John's Wort\u002Ftryptophan), lithium, anticonvulsants).\n  * Use of antidepressants and alcohol pharmacotherapy use considered if assessed by investigator and titrated down with 5 half-lives + 1-week washout f. Use of any medications likely to interact with study medication during the trial (subject to investigator's discretion).\n  * Low dose opiates permitted for pain management, however, not the night before or after dosing sessions g. Significant alcohol withdrawal (current CIWA-Ar score ≥10, including history of delirium tremens or alcohol withdrawal seizures).\n\n    h. Any current substance use disorder (SUD) other than tobacco (e.g. opiates, benzodiazepines, cannabis, psychostimulants, hallucinogens) as per clinician judgement and\u002For defined by DSM-5 criteria (measured by SCID-RV).\n\n    i. Substantial lifetime use (\\>25 total) or recent use (past 12 months) of ketamine or classic hallucinogens, such as psilocybin-containing mushrooms or LSD j. Any alcohol pharmacotherapy (e.g. naltrexone, acamprosate) within the past month.\n\n    k. Participation in other clinical trials in the previous two months l. Pregnant or lactating (contraception must be used and a sensitive pregnancy test will be performed at baseline and prior to dosing) m. Allergy or hypersensitivity to psilocybin n. Any condition or factor deemed by the study clinician to place the individual at higher risk of an adverse emotional reaction, severe active stressors such as significant legal problems, marital distress or lack of social support.","ALL","18 Years",{"count":61,"type":62},90,"ESTIMATED","INTERVENTIONAL",[65],"PHASE2","To explore the effectiveness of psilocybin-assisted therapy on reducing alcohol consumption in a double-blind, randomised, phase II clinical trial.",[68,69,70,71],"Alcohol Use Disorder","Alcohol Dependence","Depression","Anxiety",[73,74,23,75,76],"Psilocybin-assisted therapy","Randomised-Controlled Trial","Psychedelic-Assisted Therapy","Alcohol Use Disorder Therapy","NOT_YET_RECRUITING","2024-06-07",{"date":80,"type":81},"2024-06-10","ACTUAL",{"date":83,"type":62},"2024-09",{"date":85,"type":62},"2025-12",{"name":5,"class":6}]