[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"psychedelic-effects-in-healthy-volunteers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:psychedelic-effects-in-healthy-volunteers":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,53,136],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100636423","early-phase-1-psilocybin-administration-with-5-ht1a-blockade-100636423",false,"NCT07565493","Psilocybin Administration With 5-HT1a Blockade","PsilBlock1","Inclusion criteria:\n\n* 21 - 60 years old\n* Must give written or electronic informed consent\n* Must have at least a high-school level of education or equivalent (e.g. GED) and are fluent in English\n* Must be healthy and psychologically stable as determined by screening for medical and psychiatric problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n* Must agree not to take any as needed (PRN) medications on the mornings of drug sessions\n* Must agree not to take sildenafil (Viagra®), tadalafil, or similar medications within 72 hours of each drug administration.\n* Must agree to refrain from using all psychoactive substances within 24 hours or 5 elimination half-lives (whichever is greater) before psilocybin administration. Caffeine is the exception.\n* Must have a negative urine toxicology report on the same day as drug dosing.\n* Who are female and of child-bearing potential and are sexually active, must agree to use highly effective means of birth control (i.e. implants, injectables, combined oral contraceptives, progestin-containing intrauterine device (IUD) or vasectomized partner) for the duration of this study.\n* Who are male and sexually active, must agree to use contraception and refrain from sperm donation within 90 days of completing dosing sessions. Effective methods of contraception are barrier, hormonal, and sterilization methods.\n\nExclusion Criteria:\n\n* Are currently taking a medication with any significant pharmacokinetic or pharmacodynamic interactions with pindolol (e.g. beta-blockers or other anti-hypertensive medications).\n* Have a history of orthostatic hypotension or low blood-pressure.\n* Have elevated transaminases (2x the upper limit of normal)\n* Have a Child-Pugh score that falls within classes B or C.\n* Are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing.\n* Have cardiovascular conditions: coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g. atrial fibrillation, corrected QT interval (QTc) \\> 450 msec), artificial heart valve, symptomatic valvopathy, history of pulmonary hypertension or transient ischemic attack (TIA) in the past year; systolic blood pressure \\> 139, diastolic blood pressure \\> 89\n* Have epilepsy or a history of seizures\n* Have insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Are currently taking on a regular (e.g. daily) basis any medications having a centrally acting serotonergic effect, including monoamine oxidase inhibitors (MAOIs). For individuals who have intermittent or PRN use of such medications, psilocybin sessions will not be conducted until at least five half-lives of the agent have elapsed after the last dose.\n* Have a current diagnosis of schizophrenia spectrum disorders\n* Have a current diagnosis of bipolar spectrum disorders\n* Have a current diagnosis of major depressive disorder or Generalized Anxiety Disorder\n* Have a current diagnosis or history of substance induced psychotic disorder\n* Have a current DSM-5 moderate or severe alcohol or drug use disorder (excluding caffeine and nicotine)\n* Have a first degree relative with bipolar I disorder, or schizophrenia spectrum disorder.\n* Have a psychiatric condition judged to be incompatible with establishment of safe exposure to psilocybin.\n* Have a BMI ≥ 40\n* Report a known history of sleep apnea, symptoms indicative of sleep apnea, or have an Apnea-Hypopnea Index (AHI) \\> 15, or STOP BANG \\>5\n* Taking prescribed hypnotics or other medications known to alter sleep physiology: i.e., Z-drugs, Benzodiazepines, Orexin Agonists or Antagonist, Beta Blockers.\n* Regularly taking over-the-counter sleep aids (inc. melatonin and diphenhydramine) and unwilling to abstain during the study.\n* Insomnia Severity Index ≥ 10",true,"ALL","21 Years","60 Years",{"count":21,"type":22},18,"ESTIMATED","INTERVENTIONAL",[25],"EARLY_PHASE1","The purpose of this study is to assess the effects of 5-HT1A receptor blockade on the acute subjective effects of psilocybin, as measured through subjective survey measures and acute electroencephalography (EEG). Further, the investigators will assess the effects of psilocybin on post-acute sleep and dreaming through the use of sleep EEG and sleep and dream diaries.",[28],"Psychedelic Effects in Healthy Volunteers",[30,31,32,33,34,35,36,37,38,39],"Psilocybin","Sleep","Dreaming","EEG","5-HT1A","Antagonism","Altered state of consciousness","Subjective experience","Serotonin receptor","Psychedelic","RECRUITING","2026-06-22",{"date":43,"type":44},"2026-06-25","ACTUAL",{"date":46,"type":22},"2026-08-01",{"date":48,"type":22},"2028-06-15",{"name":50,"class":51},"Johns Hopkins University","OTHER",1,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":16,"sex":17,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":4,"studyType":23,"phases":65,"briefSummary":67,"conditions":68,"keywords":112,"overallStatus":128,"whyStopped":4,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":131,"completionDateStruct":132,"leadSponsor":134,"locationsCount":52},"100641475","qaiax-aihealth4u---ai-public-health-central-microcity-a-re-quantum-ai-agency-aka-ai-city-hall-project-upsto-app-nos-64074526-64063557-63903181-63729428-100641475","NCT07661823","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428","QAIAx (AIhealth4U) - AI Public Health Central: Microcity-A (re Quantum AI Agency Aka AI City Hall Project, UPSTO App Nos. 64\u002F074,526, 64\u002F063,557, 63\u002F903,181, 63\u002F729,428: A Quantum AI Public Health Agency That Provides Free Public Health Services to Registered and Sponsored Visitors\u002FOccupants for RDT&E Under 28 U.S. Code 1498 (Classified as a PPA Under 10 U.S. Code 129a)","QAIAx","Inclusion Criteria:\n\n* Individuals aged 17 to 99 years old.\n* Referral by a licensed health services professional (e.g., R.N., N.P., Ph.D., M.D.).\n* Referral by a non-profit organization (e.g., 501c3, university, church).\n* Referral by a public agency (e.g., case manager, social worker, parole\u002Fprobation\u002FPTS officer, judge).\n\nExclusion Criteria:\n\n\\* Individuals under 17 or over 99 years of age.","17 Years","99 Years",{"count":64,"type":22},1000000,[66],"NA","BRIEF SUMMARY\n\nA. \"What is the purpose of this study?\"\n\nThis study will test whether the \"AI City Hall Project\" (QAIAx), a quantum artificial intelligence (AI) public health agency, can provide free or low-cost behavioral and mental health services inside self-contained, dome-enclosed communities called \"Microcities\". Researchers want to see if AI-managed public administration, AI humanoid robots, holoportation of human-figures via 'holo-suites' (e.g., AI-119 Kikkeri Holo-Suit; AI-119 Vulcan QM-Ware) and advanced AI mental-health tools can lower housing and care costs, improve mental health outcomes (e.g., particular ecosystems using AI tools among persons with one or more addiction disorders), and be financially sustainable for people on fixed incomes or public assistance.\n\nB. \"What conditions does the study focus on?\"\n\nThe study focuses on adults with:\n\n* Autism spectrum disorders (Asperger's, autism, ADHD, ASD)\n* Substance use disorders (alcohol, opioids, marijuana, cocaine, MDMA\u002Fecstasy, tobacco\u002Fnicotine)\n* Psychiatric conditions (personality disorders, narcissism, gender dysphoria, eating disorders)\n* Behavioral addictions (gambling, sex addiction) and related issues (sex offence history).\n\nC. \"What does the study involve?\"\n\nEligible volunteers live in an omni AI-managed Microcity for up to 24 months. The community is housed in a geodesic dome that contains all daily necessities: housing, food, utilities, healthcare, and public services. Daily life is managed by an AI system (ISAC) and AI humanoid robots, with only occasional human oversight. Participants receive free mental-health treatment that may include AI-driven counselling, virtual-reality therapy (holo-suits), and non-invasive digital \"attitude inoculation\" protocols designed to reduce stress and addiction cravings. All participants also take AI-technology courses as a condition of enrolment. The study does not use any FDA-regulated drug, device, or biologic.\n\n\\*\\*Who can participate?\\*\\*\n\nYou may be able to join if you:\n\n* Are an adult (18 years or older)\n* Have a diagnosis of one of the listed mental-health or addiction disorders\n* Are referred by a licensed health professional (e.g., RN, NP, PhD, MD), a non-profit organisation (e.g., 501(c)(3), university, church), or a public agency (e.g., case manager, social worker, parole\u002Fprobation officer, judge)\n* Are willing to live in a closed, AI-managed community for up to one year and complete AI educational courses.\n\nParticipants who are veterans, receive public assistance (e.g., VA disability, SSDI\u002FSSI, Medicaid, Medicare), or are experiencing homelessness may be prioritised.\n\n\\*\\*Where is the study taking place?\\*\\* The study will be conducted at Microcity sites in the United States and internationally. The first administrative site is in Richmond, Virginia, USA. Additional sites are planned in partner nations, including tribal lands, military installations, and special economic zones.\n\n\\*\\*Who is sponsoring the study?\\*\\* The study is sponsored by \\*\\*Veterans Recovery Network Inc.\\*\\*, a non-profit organization, in collaboration with \\*\\*AI-119 Vulcan Project Research \\& Educational Technology Co. (PRETCO)\\*\\* and an AI legal agency. The study is conducted under U.S. federal research and development authorities (28 U.S.C. §1498; 10 U.S.C. §129a) and is part of a Cooperative Research and Development Agreement (CRADA) with U.S. Special Operations Command (USSOCOM).\n\nThis summary describes a planned clinical study. Not all details may be final. Information may change as the study progresses.",[69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,28,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111],"Asperger's Disorder","Asperger Disorder","Autism Disorder","Autism","ADHD - Attention Deficit Disorder With Hyperactivity","ADHD","ASD","Alcohol Abuse\u002FDependence","Alcohol Addiction","Alcohol and Other Drug Use Disorders","Alcohol and Other Substance Use Prevention","Gambling Addiction","Gambling Disorder","Sex Abuse","Sex Behavior","Sex Crimes","Sex Disorder","Sex Disorders","Gender Dysphoria, Adult","Eating Behavior Disorders","Narcotic-Related Disorders","Narcotic Addiction","Narcissism","Psychiatric Disorder","Psychedelic Experiences","Psychedelic Drug Dependence","Marijuana Use Disorder","Marijuana Abuse and Dependence","Smoking (Tobacco) Addiction","Smoking Among Youth","Smoking Abstinence","Abstinence, Sex","Opiate Substitution Treatment","Opioid Abuse (Disorder)","Opioid Abuse and Addiction","Cocaine Abuse","MDMA ('Ecstasy')","Addiction Disorders","Homeless and Low Incomes People, Refugees","Homelessness","Reliability and Validity","Anger Problems","Child Abuse, Sexual",[113,114,115,116,117,118,119,120,121,122,123,124,125,126,127],"ai city hall project","ai 119","ai119","qaia","qaiax","ai wat","veterans recovery network","veterans","addiction disorder","vulcan","artificial intelligence","agi","military","sex addiction","mental health treatment","NOT_YET_RECRUITING","2026-06-16",{"date":41,"type":44},{"date":46,"type":22},{"date":133,"type":22},"2028-12-31",{"name":135,"class":51},"Veterans Recovery Network Inc.",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":16,"sex":17,"minAge":142,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":23,"phases":146,"briefSummary":148,"conditions":149,"keywords":150,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":52},"100575474","phase-1-investigation-of-psychedelic-effects-in-psychoactive-substances-100575474","NCT06772753","Investigation of Psychedelic Effects in Psychoactive Substances","Inclusion Criteria:\n\n* Be 25 to 55 years old\n* BMI between 18 and 34 kg\u002Fm2\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 the mornings of drug session days. If the subject does not usually consume caffeinated beverages, he or she must agree not to do so on session days\n* Agree to refrain from using any psychoactive drugs, including alcoholic beverages, within 24 hours of each drug administration. Exceptions include daily use of caffeine and nicotine.\n* Be healthy and psychologically stable as determined by screening for medical problems via a personal interview, a medical questionnaire, a physical examination, an electrocardiogram (ECG), and routine medical blood and urinalysis laboratory tests\n* Agree not to take any PRN prescription medications on the mornings of the sessions unless deemed appropriate by study team.\n\nExclusion Criteria:\n\n* Women who are pregnant (as indicated by a positive urine pregnancy test assessed at intake and before each drug session) or nursing; women who are of child-bearing potential and sexually active who are not practicing an effective means of birth control (e.g. oral contraceptives, intrauterine device)\n* Cardiovascular conditions-coronary artery disease, stroke, angina, uncontrolled hypertension, a clinically significant ECG abnormality (e.g., atrial fibrillation), or transient ischemic attack-that in the clinical opinion of the screening physician or mid-level provider would put the participant at an especially high risk for adverse effects from the study.\n* Epilepsy with history of seizures\n* Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia\n* Currently taking on a regular (e.g., daily) basis any medications having a primary centrally acting pharmacological effect on serotonin neurons or medications that are Monoamine oxidase (MAO) inhibitors. For individuals who have intermittent or as needed (PRN) use of such medications, sessions will not be conducted until at least 5 half-lives of the agent have elapsed after the last dose.\n* Use of nonprescription medications, nutritional supplements, or herbal supplements except when approved by the study investigators. Exceptions will be evaluated by the study investigators and will include acetaminophen, non-steroidal anti-inflammatory drugs, and common doses of vitamins and minerals\n* History of meeting Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria for moderate or severe substance use disorder (including alcohol use disorder, but excluding tobacco), requiring that at least one of the endorsed criteria relates to prior loss of control of substance use (e.g. consuming the substance in larger amounts and for a longer amount of time than intended; persistent desire to cut down or regulate use; unsuccessful attempts to stop use; spending a great deal of time obtaining, using, or recovering from the effects of substance use).\n* Active suicidal ideation and\u002For behavior at time of screening.\n* Psychiatric disorder that in the clinical opinion of the study team would put the participant at an especially high risk for adverse effects from the study.\n* First-degree relative who meets DSM-5 criteria for a Schizophrenia Spectrum or Other Psychotic Disorder (unless disorder is Substance\u002FMedication-Induced Psychotic Disorder or Psychotic Disorder Due to Another Medical Condition), Bipolar I Disorder, or Bipolar II disorder.\n* Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.\n* Known allergy or prior adverse reaction to any of the study drugs judged by the investigator and\u002For medical staff to put the study volunteer at greater risk.\n* Known allergy or intolerance to nitroglycerin.\n* Concomitant use of any CYP2C9 and CYP3A4 inhibitors.","25 Years","55 Years",{"count":145,"type":22},50,[147],"PHASE1","The aim of this double-blind, placebo-controlled, within-subjects study is to determine whether other psychoactive substances can produce experiences akin to those seen with classic psychedelics. Screening involves a medical and psychiatric examination, including blood draw, history and physical, interviews, and questionnaires. Eligible participants will then be asked to complete up to 6 experimental drug administration session during which the participants will potentially receive and report on the subjective effects of 6 different psychoactive substances or inactive placebo. Drug assignment for some sessions will be randomized (like flipping a count or rolling a pair of dice), and both participants and study staff will be blind to the drug condition on any given day. Participants will also complete 2 preparation sessions (4 hours total) before the first experimental session, and follow-up visits after each session to discuss and debrief on the participants subjective experience.",[28],[151,152,153],"psychedelic","psychoactive","healthy","2026-02-19",{"date":156,"type":44},"2026-02-23",{"date":158,"type":44},"2025-02-05",{"date":160,"type":22},"2027-12",{"name":50,"class":51}]