[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Filament Health Corp.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100567270","phase-2-pex010-assisted-therapy-for-stimulant-use-disorder-a-safety-feasibility-and-efficacy-study-100567270",false,"NCT06666010","PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study","A Registered Clinical Trial of PEX010-Assisted Therapy for Stimulant Use Disorder: A Safety, Feasibility and Efficacy Study","PATSUD","Inclusion Criteria:\n\n* Are between 19 and 65 years old.\n* Have signed the informed consent form for the study\n* Have moderate to severe amphetamine stimulant use disorder (ASUD) as determined by the Mini-International Neuropsychiatric Interview (MINI 7.0.1), and clinical review by the study physician. The focus will be on illicit methamphetamine use.\n* Are treatment-seeking but not currently receiving other treatments for SUD.\n* Have stable housing.\n* Have a local support person (close friend or family member) that is available to accompany them home from the study drug session.\n* Are of non-childbearing potential and\u002For using adequate contraception methods as defined by Health Canada.\n* Non-childbearing potential is defined as (i) self-reported postmenopausal status (12 months of spontaneous amenorrhea and ≥ 45 years of age); or (ii) documented surgical sterilization\n* Have a negative pregnancy test at screening and prior to the study drug session. Must agree to use adequate contraception through 10 days after the study drug session. Adequate contraception methods include intrauterine devices, oral hormones plus barrier contraception, abstinence, injectable or implanted hormonal methods, or vasectomized\u002Fnon-sperm carrying sole partner. Barrier methods alone are not considered effective methods of contraception.\n* Be willing to refrain from caffeine for ≥12 hours, cannabis and stimulants for ≥24 hours, and all other drugs for ≥5 days prior to PEX010 administration such that there are no clinical signs of intoxication or withdrawal.\n* Able and willing to follow study procedure.\n* Able to understand and communicate in English.\n* Complete the Columbia Suicide Severity Rating Scale (CSSRS)\n* Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are within normal limits.\n\nExclusion Criteria:\n\n* Are experiencing or at risk for significant withdrawal.\n* Have any medical condition that would be contraindicated, including previously diagnosed conditions:\n* seizure disorder or history of seizures;\n* a history of significantly impaired hepatic function;\n* a history of unstable or uncontrolled cardiovascular disease (coronary artery disease, heart failure, clinically significant ECG abnormality);\n* uncontrolled hypertension, resting blood pressure \\> 140\u002F90 mmHg; baseline prolongation of QTc interval: \\>450 ms in both males and females;\n* a history of major central nervous system disease (history of cerebrovascular accident, masses, aneurysm);\n* a history of uncontrolled obstructive airway disease or significant respiratory compromise;\n* a history of uncontrolled thyroid disease;\n* a history of uncontrolled insulin dependent diabetes that may preclude safe participation in the study;\n* a history of narrow-angle glaucoma;\n* gastrointestinal conditions which may affect psilocybin absorption (i.e. stenosing peptic ulcer, pyloroduodenal obstruction);\n* a history of active obstructive urological conditions (i.e. symptomatic prostatic hypertrophy, bladder-neck obstruction) that may preclude safe participation in the study.\n* Have a personality disorder deemed to be high risk (antisocial, borderline, narcissistic) assessed via the SCID-5-PD.\n* Have a personal history or family history of either mania\u002Fhypomania or psychosis, including substance-induced psychosis.\n* Have any history of Hallucinogen Perception Disorder\n* Have a history of suicide attempt within the last 6 years or a suicidal ideation in the last year.\n* Are currently taking medications with known interactions with psilocybin (e.g., antidepressants, antipsychotics)\n* Are pregnant, breastfeeding, or not using adequate contraceptives if of childbearing potential.\n* Any other finding(s) based on the screening process that the investigator determines makes the candidate unsuitable for the study\n* Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are not within normal limits\n* Have baseline heart rate outside of normal limits (e.g., \\>100 beats per minute).\n* Subjects currently on medications with serotonergic activity, or taking inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.","ALL","19 Years","65 Years",{"count":21,"type":22},86,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this clinical trial is to learn if PEX010 is effective for the treatment of Stimulant Use Disorder in adults. The study will also assess the safety and feasibility of administering PEX010 to this population. The main questions it aims to answer are:\n\nDoes PEX010 reduce stimulant use?\n\nWhat medical problems do participants experience when taking PEX010?\n\nResearchers will compare an active PEX010 dose containing 25 mg psilocybin to an active placebo arm, to see if PEX010 works to reduce stimulant use.\n\nParticipants will:\n\nTake PEX010 or the active placebo once during the study, engage in cognitive behavioural therapy, and visit the clinic twice weekly for study intervention and follow-up assessments.",[28],"Stimulant Use Disorder","NOT_YET_RECRUITING","2024-10-29",{"date":32,"type":33},"2024-10-30","ACTUAL",{"date":35,"type":22},"2025-01",{"date":37,"type":22},"2028-07",{"name":39,"class":40},"Filament Health Corp.","INDUSTRY",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":23,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":4},"100562845","phase-2-pex010-assisted-therapy-for-opioid-use-disorder-oud-a-feasibility-study-100562845","NCT06608459","PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study","Open-Label, Single Arm Study of PEX010-Assisted Therapy for Opioid Use Disorder (OUD): a Feasibility Study","Inclusion Criteria:\n\n* Have a confirmed moderate to severe opioid use disorder as determined by the Mini-International Neuropsychiatric Interview (MINI), and the study physician assessment\n* Have stable housing\n* Have a local support person (close friend or family member) that is available to accompany them home\n* If they are a person able to become pregnant (PABP):\n* Be of non-childbearing potential, defined as (i) self-reported postmenopausal status (12 months of spontaneous amenorrhea and 45 years of age or older); or (ii) documented surgical sterilization (i.e., tubal ligation, hysterectomy, or bilateral oophorectomy); or\n* Have a negative pregnancy test at screening and prior to each PEX010 session, and must agree to use adequate contraception through 10 days after the last PEX010 session. Adequate contraception methods include intrauterine devices, oral hormones plus barrier contraception, abstinence, injectable or implanted hormonal methods, or vasectomized\u002Fnon-sperm carrying sole partner. Barrier methods alone are not considered effective methods of contraception.\n* Be willing to refrain from caffeine for minimum 12 hours, cannabis and alcohol for minimum 24 hours and all other drugs for at least 5 days prior to PEX010 administration such that there are no clinical signs of intoxication or withdrawal\n* Be able and willing to follow study procedure\n* Be able to understand, communicate and speak English\n* Complete the Columbia Suicide Severity Rating Scale (CSSRS)\n* Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are within normal limits.\n\nExclusion Criteria:\n\n* Are experiencing or at risk for significant withdrawal\n* Have a history of overdose with opioids within the last 10 years\n* Have any medical condition that would be contraindicated, including previously diagnosed conditions:\n* seizure disorder or history of seizures;\n* a history of significantly impaired hepatic function;\n* a history of unstable or uncontrolled cardiovascular disease (coronary artery disease, heart failure, clinically significant ECG abnormality);\n* uncontrolled hypertension, resting blood pressure greater than 140\u002F90 mmHg;\n* baseline prolongation of QTc interval greater than 450 msec in both males and females;\n* a history of major central nervous system disease (history of cerebrovascular accident, masses, aneurysm);\n* a history of uncontrolled obstructive airway disease or significant respiratory compromise;\n* a history of uncontrolled thyroid disease;\n* a history of uncontrolled insulin dependent diabetes that may preclude safe participation in the study;\n* a history of narrow-angle glaucoma;\n* gastrointestinal conditions which may affect psilocybin absorption (i.e. stenosing peptic ulcer, pyloroduodenal obstruction);\n* a history of active obstructive urological conditions (i.e. symptomatic prostatic hypertrophy, bladder-neck obstruction) that may preclude safe participation in the study.\n* Have any mental health disorder that would be contraindicated, including previously diagnosed or suspected mania\u002Fhypomania or psychosis as determined by the Modified MINI 7.0.1\n* Have a first- or second-degree relative with psychotic or bipolar disorder\n* Have a personality disorder deemed to be high risk (antisocial, borderline, narcissistic) assessed via the SCID-5-PD.\n* Have a history of suicide attempt within the last 10 years or a suicidal ideation in the last year\n* Have used any illicit stimulants or more than 3 drinks per week of alcohol in past 30 days\n* Have used classic psychedelic drugs (e.g. psilocybin, LSD, DMT, ayahuasca, or mescaline) in the last 12 months or more than 25 times in lifetime, based on self-report\n* Are currently taking medications with known interactions with psilocybin (e.g., antidepressants, antipsychotics)\n* Are pregnant, breastfeeding, or they are a PABP and not practicing an adequate form of birth control\n* Any other finding(s) based on the screening process that the investigator determines makes the candidate unsuitable for the study\n* Results from safety laboratory tests (CBC, AST and ALT, TSH, HbA1c) are not within normal limits","25 Years","55 Years",{"count":51,"type":22},10,[25],"The goal of this clinical trial is to learn if it is feasible to use PEX010 for the treatment of opioid use disorder in adults. The study will also assess the safety of PEX010. The main questions it aims to answer are:\n\nCan we successfully recruit participants, provide the drug and retain participants for the duration of the study?\n\nWhat medical problems do participants experience when taking PEX010?\n\nParticipants will:\n\nTake PEX010 twice during the study Engage in cognitive behavioural therapy Visit the clinic once or twice per week for study intervention and followup visits",[55],"Opioid Use Disorder","2024-10-15",{"date":58,"type":33},"2024-10-17",{"date":60,"type":22},"2024-12",{"date":62,"type":22},"2027-06",{"name":39,"class":40},""]