[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06772753":3,"trial-entities:NCT06772753":169,"trial-summary:NCT06772753":173},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":27,"interventions":30,"primary_outcomes":57,"secondary_outcomes":62,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":94,"locations":96,"central_contacts":124,"overall_officials":126,"references":129,"see_also_links":168},"NCT06772753","IRB00376501","Investigation of Psychedelic Effects in Psychoactive Substances","RECRUITING","2027-12","2026-02","2026-02-23","2025-02-05","Johns Hopkins University","OTHER",false,"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.",null,[18],"Psychedelic Effects in Healthy Volunteers",[20,21,22],"psychedelic","psychoactive","healthy","INTERVENTIONAL","BASIC_SCIENCE",[26],"PHASE1",{"count":28,"type":29},50,"ESTIMATED",[31,36,40,45,48,51,54],{"type":32,"name":33,"description":34,"armGroupLabels":35},"DRUG","Placebo","inactive substance",[33],{"type":32,"name":37,"description":38,"armGroupLabels":39},"Psilocybin","active comparator for psychedelic effects",[37],{"type":32,"name":41,"description":42,"armGroupLabels":43},"Ketamine","psychoactive substance",[44],"Other psychoactive drugs",{"type":32,"name":46,"description":42,"armGroupLabels":47},"Dextromethorphan (DXM)",[44],{"type":32,"name":49,"description":42,"armGroupLabels":50},"Dimethyltryptamine (DMT)",[44],{"type":32,"name":52,"description":42,"armGroupLabels":53},"Methylenedioxymethamphetamine (MDMA)",[44],{"type":32,"name":55,"description":42,"armGroupLabels":56},"Tetrahydrocannabinol (THC)",[44],[58],{"measure":59,"description":60,"timeFrame":61},"Mystical Experience Questionnaire (MEQ-30)","The MEQ is a 30-item self-report instrument intended to assess psychedelic-specific acute subjective effects of psychoactive drugs. At the end of each experimental session, participants will be instructed to rate each of the items of the MEQ relative to the experiences that the participant encountered during the course of the drug administration session. The total score on all items is then calculated as the primary outcome measure for each experimental session.\n\nScores range from 0 to 150 on this measure with higher scores reflecting more mystical experience","Week 2, Week 7",[63],{"measure":64,"description":65,"timeFrame":61},"Drug Effects Questionnaire (DEQ)","The DEQ is a self-report instrument intended to assess a range of psychoactive drug effects. Individual items include ratings of abuse-related drug effects (e.g. drug effect, good effect, bad effect, liking) and behavioral\u002Fmood states often associated with drug intoxication. The DEQ will be rated at baseline prior to the first session, and then at the end of each experimental session. The the primary outcomes for each session will be DEQ score change from baseline.\n\nScores range from 0 to 200 on this measure where 0 is the least impactful effect.","ALL","25 Years","55 Years",true,{"inclusion":71,"exclusion":78,"raw_text":93},[72,73,74,75,76,77],"Be 25 to 55 years old","BMI between 18 and 34 kg\u002Fm2","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","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.","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","Agree not to take any PRN prescription medications on the mornings of the sessions unless deemed appropriate by study team.",[79,80,81,82,83,84,85,86,87,88,89,90,91,92],"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)","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.","Epilepsy with history of seizures","Insulin-dependent diabetes; if taking oral hypoglycemic agent, then no history of hypoglycemia","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.","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","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).","Active suicidal ideation and\u002For behavior at time of screening.","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.","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.","Enrolled in another clinical trial or have received any drug as part of a research study within 30 days prior to dosing.","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.","Known allergy or intolerance to nitroglycerin.","Concomitant use of any CYP2C9 and CYP3A4 inhibitors.","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.",[95],"ADULT",[97],{"facility":98,"status":7,"city":99,"state":100,"zip":101,"country":102,"contacts":103,"geoPoint":121},"Johns Hopkins Center for Psychedelic and Consciousness Research","Baltimore","Maryland","21218","United States",[104,109,113,116,119],{"name":105,"role":106,"phone":107,"email":108},"Zach Daily","CONTACT","410-550-2533","zdaily1@jh.edu",{"name":110,"role":106,"phone":111,"email":112},"Frederick Barrett, PhD","410-550-9777","fbarrett@jhmi.edu",{"name":114,"role":115},"Frederick S. Barrett, PhD","PRINCIPAL_INVESTIGATOR",{"name":117,"role":118},"Ryan Vandrey, PhD","SUB_INVESTIGATOR",{"name":120,"role":118},"David Wolinsky, MD",{"lat":122,"lon":123},39.29038,-76.61219,[125],{"name":105,"role":106,"phone":111,"email":108},[127],{"name":128,"affiliation":12,"role":115},"Frederick Barrett, Ph.D.",[130,134,137,140,143,146,149,152,155,158,161,164],{"pmid":131,"type":132,"citation":133},"8297217","BACKGROUND","Strassman RJ, Qualls CR, Uhlenhuth EH, Kellner R. Dose-response study of N,N-dimethyltryptamine in humans. II. Subjective effects and preliminary results of a new rating scale. Arch Gen Psychiatry. 1994 Feb;51(2):98-108. doi: 10.1001\u002Farchpsyc.1994.03950020022002.",{"pmid":135,"type":132,"citation":136},"35923458","Ko K, Knight G, Rucker JJ, Cleare AJ. Psychedelics, Mystical Experience, and Therapeutic Efficacy: A Systematic Review. Front Psychiatry. 2022 Jul 12;13:917199. doi: 10.3389\u002Ffpsyt.2022.917199. eCollection 2022.",{"pmid":138,"type":132,"citation":139},"33853422","Schmid Y, Gasser P, Oehen P, Liechti ME. Acute subjective effects in LSD- and MDMA-assisted psychotherapy. J Psychopharmacol. 2021 Apr;35(4):362-374. doi: 10.1177\u002F0269881120959604. Epub 2020 Oct 8.",{"pmid":141,"type":132,"citation":142},"37222753","Breeksema JJ, Niemeijer A, Kuin B, Veraart J, Vermetten E, Kamphuis J, van den Brink W, Schoevers R. Phenomenology and therapeutic potential of patient experiences during oral esketamine treatment for treatment-resistant depression: an interpretative phenomenological study. Psychopharmacology (Berl). 2023 Jul;240(7):1547-1560. doi: 10.1007\u002Fs00213-023-06388-6. Epub 2023 May 24.",{"pmid":144,"type":132,"citation":145},"37947321","Wolinsky D, Barrett FS, Vandrey R. The psychedelic effects of cannabis: A review of the literature. J Psychopharmacol. 2024 Jan;38(1):49-55. doi: 10.1177\u002F02698811231209194. Epub 2023 Nov 10.",{"pmid":147,"type":132,"citation":148},"33779383","Earleywine M, Ueno LF, Mian MN, Altman BR. Cannabis-induced oceanic boundlessness. J Psychopharmacol. 2021 Jul;35(7):841-847. doi: 10.1177\u002F0269881121997099. Epub 2021 Mar 28.",{"pmid":150,"type":132,"citation":151},"22526529","Reissig CJ, Carter LP, Johnson MW, Mintzer MZ, Klinedinst MA, Griffiths RR. High doses of dextromethorphan, an NMDA antagonist, produce effects similar to classic hallucinogens. Psychopharmacology (Berl). 2012 Sep;223(1):1-15. doi: 10.1007\u002Fs00213-012-2680-6. Epub 2012 Apr 13.",{"pmid":153,"type":132,"citation":154},"29116367","Carbonaro TM, Johnson MW, Hurwitz E, Griffiths RR. Double-blind comparison of the two hallucinogens psilocybin and dextromethorphan: similarities and differences in subjective experiences. Psychopharmacology (Berl). 2018 Feb;235(2):521-534. doi: 10.1007\u002Fs00213-017-4769-4. Epub 2017 Nov 7.",{"pmid":156,"type":132,"citation":157},"26442957","Barrett FS, Johnson MW, Griffiths RR. Validation of the revised Mystical Experience Questionnaire in experimental sessions with psilocybin. J Psychopharmacol. 2015 Nov;29(11):1182-90. doi: 10.1177\u002F0269881115609019. Epub 2015 Oct 6.",{"pmid":159,"type":132,"citation":160},"28401522","Barrett FS, Griffiths RR. Classic Hallucinogens and Mystical Experiences: Phenomenology and Neural Correlates. Curr Top Behav Neurosci. 2018;36:393-430. doi: 10.1007\u002F7854_2017_474.",{"pmid":162,"type":132,"citation":163},"21674151","Griffiths RR, Johnson MW, Richards WA, Richards BD, McCann U, Jesse R. Psilocybin occasioned mystical-type experiences: immediate and persisting dose-related effects. Psychopharmacology (Berl). 2011 Dec;218(4):649-65. doi: 10.1007\u002Fs00213-011-2358-5. Epub 2011 Jun 15.",{"pmid":165,"type":166,"citation":167},"42649324","DERIVED","Barrett FS, Wolinsky D, Daily Z, Ciancio J, Arthur K, Vandrey R. Pilot study comparing the effects of high dose THC to high dose psilocybin and placebo in the set and setting of a classic psychedelic therapy session. Psychopharmacology (Berl). 2026 Aug 27. doi: 10.1007\u002Fs00213-026-07138-0. Online ahead of print.",[],{"nct_id":4,"conditions":170,"biomarkers":172},[171],"Healthy Volunteers",[],{"nct_id":4,"found":69,"summary":174,"prompt_version":16},{"design":175,"status":176,"heading":177,"summary":178,"follow_up":179,"word_count":180,"commitments":181,"compensation":182,"drugs_mentioned":183},"This is a double-blind, placebo-controlled study involving 50 healthy volunteers. Both participants and study staff will not know which substance is being given on any particular day.","completed","Investigating Psychedelic Effects of Psychoactive Substances","This study aims to understand if certain psychoactive substances can create experiences similar to classic psychedelics. Researchers will test psilocybin, ketamine, dextromethorphan (DXM), and dimethyltryptamine (DMT), comparing them to an inactive placebo. You might be able to join if you are a healthy volunteer between 25 and 55 years old, with a BMI between 18 and 34 kg\u002Fm2. The study will measure \"mystical experiences\" using a questionnaire at Week 2 and Week 7. The study is currently unclear about its recruitment status and plans to enroll 50 participants.","Your experiences will be measured at Week 2 and Week 7 after the drug administration.",88,"You would undergo a medical and psychiatric screening, including blood tests and interviews. If eligible, you would complete up to 6 experimental drug administration sessions.","Not stated in the trial record.",[33,37,41,46,49]]