[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psilocybin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psilocybin":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,41,65,92,118,145,168],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100642801","phase-3-efficacy-in-relapse-prevention-psilocybin-in-alcohol-use-disorder-with-depressive-symptoms-100642801",false,"NCT07638553","Efficacy in Relapse Prevention: Psilocybin in Alcohol Use Disorder With Depressive Symptoms","ERPPAD","Inclusion Criteria:\n\n* Confirmed DSM-5 diagnosis of severe AUD.\n* Scale BDI-II ((Beck Depression Inventory) ≥14\n* The last drink must have been consumed between day(D) -60 and D -10 at the inclusion visit. The patient must have had at least 1 HDD during the last drinking period NB: The last drinking period before inclusion is defined by the last 4 weeks counted from the last drink.\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n\nExclusion Criteria:\n\n* The subject is participating in an interventional study, a clinical trial, or a clinical investigation or is in a period of exclusion determined by a previous study\n* The subject refuses to sign the consent\n* It is impossible to give the subject informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient unable to give informed consent.\n* Participants planning to donate sperm within three months of psilocybin administration\n* Positive pregnancy test at inclusion for participants of childbearing age.\n* Patient who is pregnant, breastfeeding, or wishing to become pregnant during participation in the study.\n* Any use of classical psychedelic in the last year\n* Other current substance use disorder (except tobacco)\n* Diagnosed schizophrenic or bipolar disorder\n* High emotional lability (clinician-judged)\n* On antipsychotics treatment that may interfere with psilocybin.\n* Need for monoamine oxidase inhibitor (MAOI) treatment, which may interfere with psilocybin.\n* Severe suicidal ideation (high risk on the Columbia scale)\n* 1st degree family member with a diagnosed psychotic disorder\n* Severe cognitive impairment (clinician-judged)\n* CIWA-AR \\> 8\n* Medical conditions that would preclude safe participation in the trial, for example: seizure disorders; significant impairment of hepatic function; coronary artery disease; history of arrhythmia; Abnormal QT interval prolongation (QTc \\> 470 ms for women and \\>450 ms for men); heart failure; uncontrolled hypertension (greater than 165\u002F95 mmHg at screening); history of stroke; severe asthma; hyperthyroidism; narrow-angle glaucoma; stenosing gastroduodenal ulcer; pyloroduodenal obstruction; symptomatic prostatic hypertrophy or bladder neck obstruction; uncontrolled type I or type II diabetes, or a history of ketoacidosis, hyperglycemic coma, or severe hypoglycemia with loss of consciousness.","ALL","18 Years",{"count":19,"type":20},172,"ESTIMATED","INTERVENTIONAL",[23],"PHASE3","Up to 40% of individuals with alcohol use disorder (AUD) experience depression, which increases the risk of early relapse. Depression can cause relapse to occur 3 times faster in individuals with AUD who experience depressive symptoms at discharge. No treatments have been approved for individuals with both AUD and depression. Psilocybin, a psychedelic, shows promising results in treating both depression and addiction. It may be particularly effective for preventing relapse in people with AUD who also have depressive symptoms after detoxification, offering quicker action than traditional antidepressants.\n\nThe Psilocybin Alcohol Depression (PAD) pilot study, launched in February 2024, has provided critical insights for avoiding methodological flaws and demonstrated that psilocybin-assisted psychotherapy (PAP) is both feasible and acceptable. Preliminary efficacy analyses were conducted: at 12 weeks, the 25 mg group showed significantly greater reductions in drinking days (p = 0.038) and craving frequency (p = 0.045). Relapse rates were 35% in the 25 mg group and 50% in the control group (HR = 0.52 \\[0.16-1.65\\]). In the ERPPAD trial, the study authors will compare high-dose PAP with low-dose PAP in preventing relapse in individuals with AUD and depressive symptoms. The hypothesis is that high-dose PAP will be more effective than low-dose in preventing relapse over 6 months.",[26,27,28],"Alcohol Use Disorder","Depressive Sympotoms","Psilocybin","RECRUITING","2026-06-30",{"date":32,"type":33},"2026-07-01","ACTUAL",{"date":30,"type":33},{"date":36,"type":20},"2030-06",{"name":38,"class":39},"Centre Hospitalier Universitaire de Nīmes","OTHER",8,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":64},"100610463","phase-2-neuroguard-psilocybin-trial-for-preventing-chemo-induced-neuropathy-100610463","NCT07227909","NeuroGuard: Psilocybin Trial for Preventing Chemo-induced Neuropathy","Eligibility Criteria\n\n1. Participants with histologically or cytologically confirmed breast, colorectal, or head and neck cancer.\n2. Scheduled to receive platinum-based chemotherapy or taxanes (e.g., paclitaxel, docetaxel).\n3. Age 18 years or older\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.\n5. No pre-existing peripheral neuropathy greater than Grade 1 as defined by the NCI-CTCAE v5.0.\n6. No prior grade 3 AEs on current standard of care cancer treatment regimen\n7. Must have no major cognitive impairment and be oriented to person, place, and time (e.g. mini mental exam).\n8. Must demonstrate willingness to travel to MD Anderson Cancer center for all treatment and follow-up sessions, as well as consent to complete all evaluation instruments and assessments.\n9. Agree to abstain from any nicotine products for at least 8-12 hours prior to psilocybin administration until approximately 12 hours after (or when all post-session questionnaires have been completed, whichever comes earlier).\n10. Refrain from any psychoactive drugs (including alcohol) for 48 hours prior to psilocybin sessions and must refrain from psychoactive drugs 12 hours after psilocybin sessions. Must consent to urine drug screen (UDS) which will be given before receiving psilocybin. Participants with positive drug test will be retested (UDS) after 6 weeks and included if the repeated UDS is negative. Participant tested positive for a prescribed substance are eligible. Participant failing on the 2nd test (UDS) will be excluded.\n11. Must be free from any regularly scheduled psychotropic (antidepressant\u002Fanxiolytic class) medications for a minimum of 2 weeks prior to study. Intermittent or PRN use of short-acting anxiolytics or and anti-nausea medications (e.g., ondansetron) may be permitted as defined below in exclusionary criteria). Ondansetron could be taken but must be stopped at least 24 hours before psilocybin administration.\n12. Inhibitors of monoamine oxidase, UGT1A9, 1A10, and aldehyde or alcohol dehydrogenase should be discontinued 5 half-lives prior to active dose of psilocybin.\n13. Eligible subjects will have a third-party transportation by a licensed driver (e.g. friend, family or a driver) after the psilocybin session is complete. If a driver is used, a friend or family member must accompany them in the vehicle home\n14. Participants should agree to refrain from driving, operating heavy machinery, or engaging in safety-sensitive activities for the remainder of the day following psilocybin administration (for both 25mg or subperceptual 1mg placebo).\n15. Fluent in English\n\nExclusion Criteria\n\n1. History of another primary malignancy, except for:\n\n   1. Malignancy treated with curative intent and no active disease for ≥ 5 years before the first dose of study drug, with low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n2. Clinically significant suicidality or high risk of completed suicide defined as:\n\n   1. Answer 'Yes' to C-SSRS Suicidal Ideation items 4 or 5 within the last 2 months at Screening or 'since last visit' at Baseline\n   2. Report having had any C-SSRS Suicidal Behavior item within the past 12 months at Screening or 'since last visit' at Baseline, as defined by 'Yes' to any of the following on the C-SSRS: actual attempt, interrupted attempt, aborted attempt, or preparatory acts\n   3. Have any suicidal ideation or thoughts, in the opinion of the study physician or PI, that presents a serious risk of suicidal or self- injurious behavior\n3. History of bipolar disorder, psychosis (including a history of schizophrenia).\n4. Persons with first-degree relatives who have schizophrenia or other psychotic disorders, or bipolar I or II disorder diagnosed by a qualified mental health professional.\n5. Functionally limiting comorbid conditions such as second primary malignancies in CNS or chest, and history of total laryngectomy or total glossectomy precluding them from communicating.\n6. ECG with QTc \\> 450.\n7. Participants with non-MRI compatible metal implants.\n8. Asymptomatic ALT or AST elevations \\>\u002F= 5X upper limit of normal, symptomatic ALT or AST elevations \\>\u002F= 2X upper limit of normal, or total bilirubin \\>\u002F= 2X upper limit of normal.\n9. Uncontrolled diabetes Mellitus with hemoglobin A1c \\> 8.5%\n10. The effects of psilocybin on the developing human fetus are unknown. For this reason, pregnant women will be excluded (Urine test for screening), women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstaining from intercourse with the opposite sex) prior to study entry and for the duration of study participation. This includes all female participants, between the onset of menses (as early as 8 years of age) and 55 years unless the participant presents with an applicable exclusionary factor which may be one of the following:\n\n    * Postmenopausal (no menses in greater than or equal to 12 consecutive months).\n    * History of hysterectomy or bilateral salpingo-oophorectomy.\n    * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).\n    * History of bilateral tubal ligation or another surgical sterilization procedure.\n\n    Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject\u002FPartner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n11. Vulnerable populations, including children and cognitively impaired participants, will not be enrolled in this study.\n12. Participants with brain metastases.\n13. Risk for hypertensive crisis defined as Screening, Baseline, and Medication Session (day of dosing, prior to dosing) blood pressure \\>180\u002F120mmHG, HR \\>110 bpm. Of note, we will repeat vital signs for subjects with high initial reading and average three readings to determine eligibility criteria in such cases to account for normal variability in vital sign and \"white coat hypertension.\"\n14. Unstable medical conditions or serious abnormalities of complete blood count, chemistries, or ECG that in the opinion of the study physician would preclude safe participation in the trial.\n\n    Some examples include:\n    1. Uncompensated congestive heart failure\n    2. Clinically significant arrhythmias (e.g., ventricular fibrillation, torsades) or clinically significant ECG abnormality (i.e., QTC interval \\> 450)\n    3. Recent acute myocardial infarction or evidence of ischemia\n    4. Malignant hypertension\n    5. Congenital long QT syndrome\n    6. Acute renal failure\n    7. Severe hepatic impairment\n    8. Respiratory failure\n15. Significant central nervous system (CNS) pathology. Some examples include:\n\n    1. Primary or secondary cerebral neoplasm on imaging\n    2. Epilepsy and any history of seizure (regardless of if related to epilepsy) except for a onetime febrile seizure in childhood\n    3. History of stroke in the past 3 years\n    4. Untreated cerebral aneurysm\n    5. Dementia\n    6. Ongoing delirium of any kind (including with or without psychosis) in which subjects would not have the capacity to participate in the study.\n16. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation.\n\n    Examples include:\n    1. Agitation\n    2. Violent behavior\n17. Active substance use disorders (SUDs) defined as: DSM-5 criteria for moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine) within the past year\n\n    a. Extensive use of serotonergic hallucinogens (e.g., LSD, psilocybin) defined as: i. Any use in the last 12 months ii. \\>22 lifetime uses iii. History of diagnosed hallucinogen persisting perception disorder (HPPD)\n18. Concurrent Medications\n\n    1. Antidepressants\n    2. Centrally-acting serotonergic agents (e.g., MAO inhibitors)\n    3. Antipsychotics (e.g., first and second generation)\n    4. Mood stabilizers (e.g., lithium, valproic acid)\n    5. Aldehyde dehydrogenase inhibitors (e.g., disulfiram)\n    6. Significant inhibitors of UGT 1A0 or UGT 1A10\n    7. serotonin-acting dietary supplements (such as 5-hydroxytryptophan or St. John's wort)\n    8. efavirenz\n    9. Other Medications Listed in Section 3.1 19. Have a positive urine drug test including Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Cannabis, Methamphetamine, MDMA, Methadone, Opiates (Morphine, Oxycodone), Phencyclidine (PCP), and Tetrahydrocannabinol (THC).\n\n    \u003C!-- -->\n\n    1. Note: Prescribed opiate medications (e.g., cancer-related pain) will be allowed to continue through the study period for participants who have been on a stable dose of such medicine for at least 1 month prior to Screening, as determined during review of concomitant medications.\n    2. Note: Prescribed benzodiazepine medications and nonbenzodiazepine sleeping medications will be allowed to continue through the study period for participants who have been on a stable dose of such a medicine for at least 6 weeks prior to Screening, as determined during review of concomitant medications.\n    3. Note: Participants using cannabis, including legal cannabis, for any purposes must agree to refrain from use beginning at Screening, as confirmed with a negative Baseline drug test, and through to the end of the study.\n    4. Note: Participants using prescribed psychostimulants (amphetamines and Ritalin), must agree to refrain from use 72 hours prior to dosing and until 12 hours after dosing.\n\n20\\. Have a psychiatric condition judged to be incompatible with establishment of rapport with the study therapists or safe exposure to psilocybin\n\n1. Have any psychological or physical symptom, medication or other relevant finding prior to randomization, based on the clinical judgment of the PI or relevant clinical study staff that would make a participant unsuitable for the study.\n2. Have an allergy or intolerance to any of the materials contained in either drug product Be enrolled in another clinical trial assessing intervention(s) for prevention or treatment of any pain-related symptoms",{"count":48,"type":20},83,[50],"PHASE2","To learn if psilocybin can help to prevent or decrease the severity of chemotherapy-induced peripheral neuropathy (CIPN) in patients who are receiving chemotherapy for the treatment of breast, colorectal, and In this study, psilocybin is being compared to standard supportive care and to a placebo.",[28,53],"Neuropathy","NOT_YET_RECRUITING","2026-06-22",{"date":57,"type":33},"2026-06-24",{"date":59,"type":20},"2026-11-04",{"date":61,"type":20},"2031-01-31",{"name":63,"class":39},"M.D. Anderson Cancer Center",1,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":16,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":64},"100636470","phase-2-group-pacbt-for-depression-100636470","NCT07566104","Group PACBT for Depression","Group Psilocybin-assisted Cognitive Behavioral Therapy for Major Depressive Disorder","Inclusion Criteria:\n\n* Ages 21-60,\n* Fluent in English\n* Able to swallow capsules,\n* Meets for a current major depressive episode or a history of major depressive episodes based on the DSM-5 criteria (American Psychiatric Association, 2013),\n* Active current depressive symptoms (i.e., scores \\>16 on the Hamilton-Depression Rating Scale covering the prior 2 weeks; Hamilton, 1986),\n* Have an identified support person (i.e., trusted adult friend or relative) who can pick up the individual from UCLA Semel Institute and drive individual home following psilocybin sessions,\n* For women of child-bearing potential - using one form of highly effective contraception (e.g., oral contraceptive pill) and willingness to continue contraceptive use for duration of study. Must be willing to take on-site pregnancy tests.\n* Agree to refrain from any psychoactive drug (including alcohol) within 24 hours of each drug session and during the drug sessions. Participants will be allowed to consume their usual amount of caffeine prior to and after the drug sessions.\n* Agree to not take any PRN medications on the mornings of the drug sessions\n* Has been medically cleared for the study by a physician\n* Participants must remain on anti-hypertensive medications if prescribed previously to manage hypertension\n\nExclusion Criteria:\n\n* A personal or family history (first-degree) of psychosis or mania\n* Resting blood pressure above 140 systolic, 90 diastolic or heart rate \\> 90 beats per minute (averaged across four separate measurements)\n* Meeting criteria for a DSM-5 cluster B personality disorder (narcissistic, histrionic, borderline, antisocial personality disorder),\n* Active suicidality (i.e., HAM-D item 3 score of greater than 3) or other psychiatric disturbance requiring acute treatment\n* Current use of antidepressants or other serotonergic-affecting substances (e.g., St. John's Wort and 5-hydroxytryptophan), lithium, or efavirenz \\[regardless of whether the drug(s) is\u002Fare prescribed for MDD or other conditions\\]\n* Current use of opioids (e.g., codeine, fentanyl, hydrocodone, meperidine, tramadol)\n* Currently receiving cognitive behavioral therapy,\n* Any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, myocardial infarction, tachycardia, artificial heart valve, a clinically significant screening ECG abnormality, or any other significant cardiovascular condition\n* QTc interval measurement of \\> 450 ms in males or \\> 460 ms in females as measured by the baseline ECG\n* A history of stroke or Transient Ischemic Attack (TIA)\n* Epilepsy or history of seizures\n* Insulin-dependent diabetes\n* Meeting criteria for a DSM-5 substance abuse or dependence within prior 6 months (including for nicotine and cannabis)\n* Positive urine drug screen for illicit substances (not including cannabis)\n* Use of other psychedelics or ketamine within prior 12 months\n* Adverse prior reaction to a 5-HT2A receptor agonist psychedelic agent\n* Pregnant, trying to get pregnant, or nursing","21 Years","60 Years",{"count":75,"type":20},30,[50],"This study will seek to determine the (1) acceptability and (2) feasibility of psilocybin as an adjunct to cognitive-behavioral therapy, delivered as a group treatment (G-PACBT) for major depressive disorder and (3) explore the clinical effects of G-PACBT on depressive symptoms and psychosocial functioning.",[79,28,80],"Depression - Major Depressive Disorder","Cognitive Behavioral Therapy",[82],"group treatment","2026-04-28",{"date":85,"type":33},"2026-05-04",{"date":87,"type":20},"2027-01",{"date":89,"type":20},"2028-12",{"name":91,"class":39},"University of California, Los Angeles",{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":4,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":101,"targetDuration":4,"studyType":21,"phases":103,"briefSummary":105,"conditions":106,"keywords":107,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":64},"100569280","phase-1-the-recap2-study-midazolam-and-psilocybin-100569280","NCT06692192","The RECAP2 Study: Midazolam and Psilocybin","Role of Experience, Conscious Awareness, and Plasticity in Psilocybin's Behavioral Effects - Follow-Up Study (The RECAP 2 Study)","Inclusion Criteria:\n\n* Age 18 to 65 years at screening, of any identified gender and racial\u002Fethnic group\n* Physically healthy; does not meet criteria for an exclusionary medical condition\n* English-speaking (able to provide consent and complete questionnaires)\n* Modest decrement in self-reported wellbeing without the presence of a DSM-5 Axis I mood or anxiety disorder\n* Able to undergo magnetic resonance imaging (MRI) and transcranial magnetic stimulation (TMS)\n\nExclusion Criteria:\n\n* Exclusionary DSM-5 psychiatric diagnosis and\u002For active suicidal ideation\n* Exclusionary medical conditions\n* Clinically significant safety lab abnormalities (i.e., Complete Blood Count with Differential, Comprehensive Metabolic Panel, and urinalysis)\n* Clinically significant electrocardiogram (ECG)\n* Use of psychotropic or CNS-altering medications within 3 months of screening\n* Hypertension or tachycardia",true,"65 Years",{"count":102,"type":20},60,[104],"PHASE1","The goal of this clinical trial is to learn about the role that inducing neuroplasticity (the brain's ability to adapt and change) plays in the behavioral effects of psilocybin in people who have experienced a mild decline in emotional wellbeing.\n\nResearchers will compare different doses of psilocybin combined with midazolam or placebo to see what dose induces increased wellbeing.\n\nParticipants will:\n\n* Receive one of four possible combinations of medications\n* Undergo an MRI\n* Complete questionnaires\n* Undergo transcranial magnetic stimulation (TMS) and EEG",[28],[108],"sub-optimal wellbeing","2026-03-31",{"date":111,"type":33},"2026-04-03",{"date":113,"type":33},"2025-08-07",{"date":115,"type":20},"2027-12",{"name":117,"class":39},"University of Wisconsin, Madison",{"id":119,"slug":120,"hasResults":11,"nctId":121,"briefTitle":122,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":99,"sex":16,"minAge":72,"maxAge":100,"enrollmentInfo":125,"targetDuration":4,"studyType":21,"phases":127,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100626270","phase-1-the-effects-of-psilocybin-in-healthy-volunteers-psychological-biochemical-and-electrophysiological-biomarkers-100626270","NCT07433452","The Effects of Psilocybin in Healthy Volunteers: Psychological, Biochemical and Electrophysiological Biomarkers.","PSILOBIOMARKER","Inclusion Criteria:\n\n* Male or Female adults ages 21-65 at the time of screening.\n* Females of childbearing potential must have a negative pregnancy test at all designated visits.\n* Have a self-reported interest in psychedelic drugs and altered states of consciousness.\n* Never have used a classic, serotonergic psychedelic (such as psilocybin, psilocybin, LSD, or ayahuasca) or a dissociative anesthetic such as ketamine or PCP), or maximum one experience 5 years before the study starting without untoward effects.\n* Participants must be free of current or past substance use dependence or disorders, as determined by a semi-structured clinical interview for DSM-5 diagnoses (SCID-DSM-5).\n* Have a Body Max Index (BMI) 18-34 kg\u002Fm2 and an abdomen circumference ≤ 90 for women and 97 for men.\n* In the investigator's opinion, participants are reliable and willing and able to comply with the protocol requirements and procedures.\n* In addition to meeting the inclusion criteria outlined, it is important to develop a positive rapport between all individuals both participating in and coordinating the study.\n\nExclusion Criteria:\n\n* Any psychiatric, cardiovascular, neurological, or other disorders that may be aggravated by participation in the study, or complicate interpretation of the study's results.\n* Any substance use disorder.\n* For women, a positive pregnancy test, or not using a reliable method of birth control.\n* Personal or family history of severe psychiatric disorders (schizophrenia, bipolar disorder, addiction, ASD) and\u002For psychosis in the first and second degree.\n* During the interview family history is asked in detail. Example: Did your parents or grandparents received a diagnosis of schizophrenia, bipolar disorder, depression.... Did somebody die by suicide? ...Did somebody was hospitalized in a psychiatric hospital? Did somebody in the family was judged \"strange\"? Different? Even if 40 years ago the diagnosis of depression or bipolar disorder was less precise, do you have the impression that somebody was sick?\n* A resting blood pressure \\> 140 systolic and 90 diastolic (mmHg).\n* Cardiovascular diseases including valvulopathy.\n* Current tricyclic antidepressant, lithium, SSRIs, first- and second-generation ketamine antipsychotics, or MAOI prescription regimen.\n* Current dietary supplementation of 5-hydroxytryptophan and St. John's Wort.\n* Medically significant condition rendering unsuitability for the study (e.g., diabetes, epilepsy, severe cardiovascular disease, hepatic or renal failure e.g. CLRC \\\u003C 30 ml\u002Fmin etc.).\n* History of serious suicide attempts requiring hospitalization.\n* Significant history of mania (determined by study psychiatrist and medical records).\n* Psychiatric condition judged to be incompatible with establishment of rapport with therapy team and\u002For safe exposure to psilocybin, e.g. borderline personality disorder.\n* Blood or needle phobia.\n* Participants who do not agree to use an acceptable contraceptive method throughout their participation in study.\n* Use of contraindicated medication.",{"count":126,"type":20},50,[104],"In this study, participants will received either psilocybin (the active ingredient found in certain mushrooms) or an inactive placebo (a look-alike tablet with no active drug). The psilocybin is supplied by Filament Health (Burnaby, British Columbia).\n\nAfter psilocybin ingestion, the body quickly converts it into psilocin, which is the form that produces the temporary psychological effects. Psilocin mainly works by interacting with serotonin receptors in the brain, especially a type called the 5-HT2A receptor.\n\nThis study will be done in healthy volunteers using a single oral dose of 25 mg (one tablet by mouth), consistent with doses used in previous clinical research.\n\nThe goal is to understand the biological, psychological, and high-density EEG (hd-EEG) changes that can happen after a one-time dose of psilocybin.",[130,131,28],"Healthy Participants","Placebo - Control",[133,134,135],"psychdelics","biomarkers","hd-EEG","2026-02-19",{"date":138,"type":33},"2026-02-25",{"date":140,"type":20},"2026-09-01",{"date":142,"type":20},"2029-09-01",{"name":144,"class":39},"Gabriella Gobbi",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":4,"eligibilityCriteria":151,"healthyVolunteers":99,"sex":16,"minAge":17,"maxAge":100,"enrollmentInfo":152,"targetDuration":4,"studyType":21,"phases":154,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":162,"completionDateStruct":164,"leadSponsor":166,"locationsCount":64},"100616496","phase-2-psilocybin-assisted-physical-therapy-in-chronic-low-back-pain-100616496","NCT07306364","Psilocybin-Assisted Physical Therapy in Chronic Low Back Pain","Psilocybin in Chronic Low Back Pain: An Integrative Study of Lab-Based Mechanisms and Real-World Physical Therapy Outcomes","Inclusion Criteria:\n\n* 1\\. Ability to provide informed consent in English.\n* 2\\. Provision of signed and dated informed consent form.\n* 3\\. Stated willingness to comply with all study procedures and availability for the duration of the study.\n* 4\\. Male and female participants aged 18-65 years.\n* 5\\. CLBP, uniformly defined as high-impact or bothersome non-cancer low back pain lasting ≥ three months that occurs most days and limits life or work activities.\n* 6\\. At least moderate pain-related disability as measured by a total score on the ODI ≥ 15.\n* 7\\. For women of childbearing potential, must have a negative urine pregnancy test at screening and immediately before dose administration.\n\n  * Negative urine pregnancy test at screening and immediately before dose administration.\n  * Use of one highly effective contraception (e.g., IUD, barrier method) for ≥ 1 month prior to screening.\n* 8\\. Participants are required to commit to employing dual contraceptive methods throughout the study and to abstain from sperm or egg donation during the study period and for 28 days following the final drug dose for ova, and for 90 days following the final drug dose for sperm. Dual contraceptive methods encompass the use of a barrier contraceptive, such as condoms, coupled with another effective method capable of preventing pregnancy, such as oral or parenteral contraceptives, intrauterine devices, spermicide, and the like.\n* 9\\. Resting blood pressure ≤ 140\u002F90 mmHg (average of three screenings) and resting heart rate 60-100 bpm.\n* 10\\. Normal screening EKG: QTcF \\\u003C 450 ms; no clinically significant arrhythmias, ischemia, or bundle branch block.\n* 11\\. Hepatic and renal function within acceptable limits: AST\u002FALT ≤ 2× ULN; bilirubin ≤ 1.5× ULN; eGFR ≥ 50 mL\u002Fmin\u002F1.73 m².\n* 12\\. Ability to safely ingest oral capsules for the dosing visit.\n* 13\\. Safe transportation plan after the dosing session (e.g., designated driver).\n* 14\\. Signed medical release permitting the study team to communicate with outside providers for medication\u002Ftherapy history or crisis management.\n* 15\\. Designation of an adult emergency contact (relative, spouse, close friend) willing to monitor for mood\u002Fbehavior changes post-dose and provide transportation if needed.\n* 16\\. Agreement to attend preparatory and integration sessions, follow-up visits, and to respond to telephone\u002Femail contacts.\n\nExclusion Criteria:\n\n* 1\\. Hallucinogen Use Disorder or Hallucinogen Persisting Perceptual Disorder.\n* 2\\. Personal or family history of schizophrenia, schizoaffective disorder, bipolar disorder, or major depressive disorder with psychotic features; any history of substance-induced psychosis or current psychotic symptoms at Screening per the Brief Psychiatric Rating Scale.\n* 3\\. Active suicidal ideation or behavior in the past 3 months, as indicated on the C-SSRS.\n* 4\\. Lifetime use of classic psychedelics (5-HT2A agonists) within the preceding 12 months, or unwillingness to abstain from their use for up to 4 weeks post-dose.\n* 5\\. Current moderate or severe depression, as indicated by a score of ≥ 3 on the depression subscale (items 1 and 2) of the Patient Health Questionnaire-4 (PHQ-4).\n* 6\\. Total score on the ODI ≥ 35, indicating an individual is \"completely disabled.\"\n* 7\\. Meeting DSM-5 criteria for alcohol or substance use disorders (other than tobacco use disorder) within the last year; use of THC-containing products \\> 2×\u002Fweek over the past 30 days or unwillingness to abstain for at least 1 week pre-dose through 4 weeks post-dose. Abstinence will be confirmed via point-of-care urine 11-nor-9-carboxy-THC testing with a cut-off ≤ 50 ng\u002FmL.\n* 8\\. Clinically significant medical disorders (e.g., moderate-to-severe hepatic impairment \\[Child-Pugh B\u002FC\\], AST\u002FALT \\> 2× ULN, bilirubin \\> 1.5× ULN, eGFR \\\u003C 50 mL\u002Fmin\u002F1.73 m², diabetes, uncontrolled thyroid disease).\n* 9\\. Neurological conditions altering nociceptive response (e.g., stroke, neuropathy) or history of seizure\u002Fhead injury with \\> 30 minutes loss of consciousness.\n* 10\\. Contraindications to nociceptive testing (e.g., untreated hypertension \\> 140\u002F90 mmHg).\n* 11\\. Current use of serotonergic medications (e.g., SSRIs, SNRIs, TCAs).\n* 12\\. Current regular use of medications affecting pain (e.g., opioids, gabapentinoids, cyclobenzaprine).\n* 13\\. Current regular use of inhibitors of UGT1A9, UGT1A10, MAO and aldehyde or alcohol dehydrogenase.\n* 14\\. Major neurocognitive disorders (e.g., dementia) or any cognitive deficit impairing consent\u002Fparticipation.\n* 15\\. Abnormal EKG findings (e.g., ischemia, infarct patterns, bundle branch block, atrial fibrillation, QTcF ≥ 450 ms).\n* 16\\. Resting QTcF prolongation or other torsades de pointes risk factors (uncontrolled electrolyte disturbances, family history of sudden death, torsadogenic medications).\n* 17\\. Any other condition that, in the investigator's judgment, would compromise safety or ability to complete the study.\n* 18\\. Known or suspected cardiovascular disease, including but not limited to atrial fibrillation, coronary artery disease, history of myocardial infarction, structural heart disease, congestive heart failure, or uncontrolled hypertension.",{"count":153,"type":20},45,[50],"The purpose of this research study is to investigate whether a single administration of psilocybin can improve interoceptive awareness (awareness of bodily sensations) in individuals with chronic low back pain undergoing physical therapy, and whether these improvements are linked to pain relief and better physical therapy outcomes.",[157,158,28],"Chronic Low Back Pain (CLBP)","Physical Therapy","2025-12-24",{"date":161,"type":33},"2025-12-29",{"date":163,"type":20},"2026-06",{"date":165,"type":20},"2029-06",{"name":167,"class":39},"Yale University",{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":4,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":16,"minAge":175,"maxAge":100,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":64},"100552351","phase-1-psychedelic-assisted-group-program-for-first-responders-100552351","NCT06471959","Psychedelic-assisted Group Program for First Responders","Assessing the Feasibility of a Custom Psychedelic-assisted Group Program on Mental and Physical Health in First Responders","Inclusion Criteria:\n\n* Male or female, 19 to 65 years of age\n* Must be a first responder, any work status (Employed full-time or part-time, Off-work, Retired, Volunteer)\n* Fluent in English\n* Able to understand the informed consent form, study procedures and willing to participate in study\n* Clinically diagnosed with a mental health condition such as:\n\n  1. Depression\n  2. Chronic anxiety\n  3. Obsessive-compulsive disorder\n  4. PTSD\n  5. Unresolved grief\n  6. Adjustment Disorder\n  7. Acute Stress Disorder\n* Stable dose of medications for the last three months, with no changes anticipated for the duration of the study\n* Medical clearance by the Investigator (MD) prior to study enrollment\n* Willing and able to attend two in-person sessions throughout the 12-week program, in addition to remote sessions\n* Concurrent therapy is allowed if the type and frequency of the therapy has been stable for at least two months prior to screening and is expected to remain stable during participation in the study.\n* Agree to consume approximately the same amount of caffeine-containing beverage (e.g., coffee, tea) that he\u002Fshe consumes on a usual morning, before arriving at the research unit on Week 10. If the participant does not routinely consume caffeinated beverages, he\u002Fshe must agree not to do so on Week 10.\n* Agree that for one week before the drug sessions, he\u002Fshe will refrain from taking any nonprescription medication, nutritional supplement, or herbal supplement (specifically SAM-e, 5-HTP, L-tryptophan, St John's Wort) except when approved by the study Investigator. Exceptions will be evaluated by the Investigator and may include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals.\n* Agree to refrain from consuming alcohol within two days prior to the Week 10 visit.\n* Agree not to take any \"as needed\" medications on the morning of the Week 10 visit.\n* Agree to use of highly effective methods of contraception during the study (females)\n* Normal body mass index (BMI 18.5-24.9)\n\nExclusion Criteria:\n\n* Current or past history of schizophrenia, psychotic disorder (unless substance induced or due to a medical condition), bipolar disorder, delusional disorder, dissociative disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, anorexia nervosa, bulimia nervosa or substance abuse, as assessed by medical history\n* Presence of active psychotic symptoms\n* Currently diagnosed psychotic disorder in first-degree relatives, not including psychotic disorders secondary to an apparent medical reason, e.g. brain injury, dementia, or lesions of the brain, as assessed by medical history.\n* Diagnosis of dementia or delirium\n* Risk of suicide as determined by the Investigator\n* Significantly intrusive PTSD as determined by the Investigator\n* Extreme emotional lability can be disruptive to the group milieu and is a relative exclusion criterion\n* Uncontrolled cardiopulmonary disease, cardiovascular disease, or hypertension\n* Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, vascular or any other major concurrent illness that, in the opinion of the Investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if he\u002Fshe takes part in the study\n* Psychoactive substance use (MDMA, psilocybin, LSD) within the previous two months.\n* If female and of child-bearing potential: pregnant, suspected or planning to become pregnant during the study\n* Participation in another clinical trial (currently or within the last 30 days)\n* Current use of rifamycins (rifampin, rifabutin, rifapentine), anticonvulsants (carbamazepine, phenytoin, phenobarbital), nevirapine, efavirenz, taxol, dexamethasone); cytochrome P450 Inhibitors - including all HIV protease inhibitors, verapamil, diltiazem, itraconazole, ketoconazole, erythromycin, clarithromycin, azithromycin, and troleandomycin; ergot alkaloids, pimozide, midazolam, triazolam, lovastatin, simvastatin, fentanyl, warfarin, metoprolol, propranolol, buspirone, tramadol, selegiline, sumatriptan.\n* Current use of inhibitors of UGT1A9 and 1A10, monoamine oxidase inhibitors (MAOIs), Tricyclic antidepressants, aldehyde dehydrogenase inhibitors (ALDHs) and alcohol dehydrogenase inhibitors (ADHs).","19 Years",{"count":177,"type":20},32,[104,50],"This study is a two-group feasibility study of oral psilocybin combined with a 12-week group-based program, customized for firefighters. Trained facilitators will help create a trauma-informed space for the group (n = 6-8) to thrive and promote cognitive resilience. The topics covered throughout the 12 weeks include breath-work, mindfulness, self-compassion, embodiment, and Internal Family Systems work.\n\nGroup 1 (control): 12-week group-based program, with a breathwork day at week 10\n\nGroup 2 (intervention): 12-week group-based program, with a 10mg dose of psilocybin (PEX010) at Week 10\n\nAssessment timepoints:\n\n* Baseline\n* Mid-program (Week 6)\n* End of program (Week 12)\n* 6-month follow up",[28,181],"Psychotherapy, Group","2024-06-21",{"date":184,"type":33},"2024-06-24",{"date":186,"type":20},"2025-01-01",{"date":188,"type":20},"2025-09-01",{"name":190,"class":191},"Empower Research Inc","INDUSTRY"]