[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Sunstone Medical\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":85},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,39,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"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":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100636705","phase-2-mdma-therapy-in-veterans-with-ptsd-100636705",false,"NCT07569159","MDMA Therapy in Veterans With PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of MDMA-Assisted Therapy for Veterans With Posttraumatic Stress Disorder (PTSD)","Inclusion Criteria:\n\n* Veterans who are at least 18 years old\n* Are able to swallow pills\n* Are able to complete all protocol required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.\n* Proficient in speaking and reading English.\n\nExclusion Criteria:\n\n* Condition impairing oral intake or digestive absorption.\n* Unable to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and plan as endorsed on items 5 on C-SSRS within the past 3 months\n* Cardiovascular disease, including, but not limited to, coronary artery disease (CAD) and chronic heart failure (CHF)\n* A history of, or a current primary schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.\n* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.\n* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.","ALL","18 Years",{"count":19,"type":20},52,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A Phase 2, single-center, fixed-dose, open-label study will explore the efficacy, safety, and tolerability of a 120 mg dose of oral MDMA followed by a supplemental dose of 60 mg MDMA in conjunction with therapy in individual versus group settings for adult veterans diagnosed with PTSD.",[26],"Post Traumatic Stress Disorder","RECRUITING","2026-06-30",{"date":30,"type":31},"2026-07-01","ACTUAL",{"date":28,"type":20},{"date":34,"type":20},"2027-08",{"name":36,"class":37},"Sunstone Medical","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":47,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":51,"conditions":52,"keywords":54,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":58,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":38},"100585485","phase-2-psilocybin-assisted-therapy-for-sexual-assault-related-ptsd-100585485","NCT06902974","Psilocybin-Assisted Therapy for Sexual Assault-Related PTSD","A Phase 2, Open-Label Study Investigating the Safety and Efficacy of Psilocybin-Assisted Therapy for Sexual Assault-Related Posttraumatic Stress Disorder (PTSD)","SUN004","Inclusion Criteria:\n\n* Cisgender women who are at least 18 years old.\n* Meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for current PTSD secondary to sexual assault (i.e., index trauma is sexual assault that occurred 6 or more months in the past).\n* CAPS-5 score of 25 or higher at Baseline.\n* Are able to swallow pills.\n* Are willing to be driven home after the Dosing Session with a family member or caregiver or trusted transportation.\n* Are able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.\n* If able to become pregnant (i.e., with uterus and associated reproductive organs, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to the Dosing Session, and must agree to use adequate birth control through 10 days after the Dosing Session if sexually active with a biologically male partner. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).\n* Must agree to inform the clinical investigators within 48 hours of any medical conditions and procedures.\n* Are proficient in speaking and reading English.\n* Agree to have all clinic visit sessions recorded to audio and\u002For video. Participants may opt out of the data analysis of the recordings.\n* Agree to the following lifestyle modifications: a light breakfast 2 to 3 hours before dosing is permitted, however, participants will refrain from caffeine and nicotine 2 hours prior to dosing sessions and at least 6 hours after dosing, abstain from alcohol for 24 hours prior to dosing, not enroll in any other interventional clinical studies during the duration of the study, be driven home after the Dosing Session, and commit to medication dosing, therapy, and study procedures.\n* Agree to refrain from beginning new medication and\u002For psychotherapy treatment.\n* Continued treatment with SSRIs will be permitted if participants have been on a stable dose for 3 months or longer prior to enrollment. However, participants must be tapered off of monoamine oxidase inhibitors (MAOIs) prior to dosing.\n\nIn addition, participants may remain in stable (\\> 3 months) psychotherapy.\n\n* May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines.\n* May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n* May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by the principal investigator or designated physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the principal investigator or designated physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.\n* May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the principal investigator or designated physician.\n* May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n\nExclusion Criteria:\n\n* Male\n* Condition impairing oral intake or digestive absorption.\n* Are not able to give adequate informed consent.\n* Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 3 months\n* Have any current problem which, in the opinion of the principal investigator or designated physician, might interfere with participation.\n* Would present a serious risk to others as established through clinical interview and contact with treating therapist.\n* Have a history of, or a current primary, schizophrenia, schizoaffective disorder or any form of psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1, or personality disorders.\n* Require ongoing concomitant therapy with a psychiatric medication with exceptions described below (see Section 6.6).\n* Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n* Have evidence or history of recent stroke (\\\u003C 6 months from signing of ICF), recent myocardial infarction (\\\u003C 6 months from signing of ICF), or clinically significant arrhythmia within 1 year of signing the ICF.\n* Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of psilocybin administration.\n* Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher).\n* Abnormal and clinically significant results on vital signs, ECG, or laboratory tests at screening and baseline\n* Have symptomatic liver disease.\n* Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control if sexually active with a biologically male partner.\n* Have hypersensitivity to any ingredient of the study drug.\n* Positive urine drug screen for illicit drugs or drugs of abuse prior to the Dosing Session. Any positive urine drug test will be reviewed with participants to determine the pattern of use and eligibility will be determined at the investigator's discretion.\n* Current enrollment in any investigational drug or device study or participation in such within 30 days of screening.\n* Other personal circumstances and behavior judged to be incompatible with establishment of rapport or safe exposure to psilocybin or completion of clinical study procedures (e.g., active participation in legal proceedings).","FEMALE",{"count":49,"type":20},70,[23],"A Phase 2, Open-Label Study to explore the efficacy, safety, and tolerability of psilocybin-assisted therapy in women with sexual assault-related Posttraumatic Stress Disorder (PTSD).",[26,53],"PTSD",[53,55,56,57],"sexual assault","psilocybin","posttraumatic stress disorder",{"date":30,"type":31},{"date":60,"type":31},"2026-05-23",{"date":62,"type":20},"2028-05",{"name":36,"class":37},{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":38},"100484191","phase-2-mdma-assisted-therapy-for-adjustment-disorder-ad-in-dyads-of-patients-with-cancer-and-a-concerned-significant-other-100484191","NCT05584826","MDMA-assisted Therapy for Adjustment Disorder (AD) in Dyads of Patients With Cancer and a Concerned Significant Other","Inclusion Criteria:\n\n1. Are at least 18 years old\n2. Are considered important to their well-being by patient participants (e.g., spouse or close family member)\n3. Meet DSM-5 criteria for current AD (no criteria for another mental disorder and does not correspond to an exacerbation of a preexisting mental disorder. Does not represent a normal bereavement)\n4. Satisfies diagnostic criteria for AD using the ADNM-2020 (score ≥ 47.5 on the scale)\n5. Are able to swallow pills.\n6. Are willing to be driven home after the experimental sessions, either by a driver arranged by the participant or by the site personnel or taxi and agree not to drive after each Experimental Session until the therapists deem it safe to do so\n7. If able to become pregnant (i.e. assigned female at birth, fertile, following menarche and until becoming post-menopausal unless permanently sterile), must have a highly sensitive negative pregnancy test at study entry and prior to each Experimental Session, and must agree to use adequate birth control through 10 days after the last Experimental Session. Adequate birth control methods include intrauterine device (IUD), injected, implanted, intravaginal, or transdermal hormonal methods, abstinence, oral hormones plus a barrier contraception, vasectomized sole partner, or double barrier contraception. Two forms of contraception are required with any barrier method or oral hormones (i.e. condom plus diaphragm, condom or diaphragm plus spermicide, oral hormonal contraceptives plus spermicide or condom).\n8. Must agree to inform the Clinical Investigators within 48 hours of any medical conditions and procedures\n9. Are proficient in speaking and reading English\n10. Agree to have all clinic visit sessions recorded to audio and video\n11. Agree to the following lifestyle modifications (described in more detail in Section 4.3 Lifestyle Modifications): comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not enroll in any other interventional clinical trials during the duration of the study, be driven home after each Experimental Session, and commit to medication dosing, therapy, and study procedures.\n12. May have well-controlled hypertension that has been successfully treated with anti-hypertensive medicines, if they pass additional screening to rule out underlying cardiovascular disease.\n13. May have asymptomatic Hepatitis C virus (HCV) that has previously undergone evaluation and treatment as needed.\n14. May have alcohol or substance use disorder if participant is not in withdrawal or requiring detox. Participants must have a plan, agreed upon by investigator, therapy team, and study physician, to reduce use of alcohol or other substances and to manage symptoms without self-medicating. Enrollment will require that, in the judgment of the investigator, therapy team, and study physician, the plan for decreasing substance use is realistic and has a good chance of succeeding in order to prevent substance use from impacting the safety or efficacy of the investigational treatment.\n15. May have a history of or current Diabetes Mellitus (Type 2) if additional screening measures rule out underlying cardiovascular disease, if the condition is judged to be stable on effective management, and with approval by the study physician.\n16. May have hypothyroidism if taking adequate and stable thyroid replacement medication.\n17. May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.\n\nExclusion Criteria:\n\n1. Concurrent or recent (less than four weeks) cytotoxic chemotherapy or radiation therapy, that impairs general level of physical functioning (index participant)\n2. Weigh less than 48 kg\n3. Condition impairing oral intake or digestive absorption\n4. Are not able to give adequate informed consent\n5. Significant suicide risk as defined by suicidal ideation with intend and a plan as endorsed on items 5 on the C-SSRS within the past 6 months or at V0 (see Appendix A)\n6. Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation\n7. Would present a serious risk to others as established through clinical interview and contact with treating psychiatrist.\n8. Have a history of, or a current primary psychotic disorder, major depressive disorder with psychotic features, bipolar affective disorder type 1 or history of or current dissociative identity disorder\n9. Require ongoing concomitant therapy with a psychiatric medication with exceptions described in Section 8.0: Concomitant Medications.\n10. Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.\n11. Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session;\n12. Have a history of ventricular arrhythmia at any time, other than occasional premature ventricular contractions (PVCs) in the absence of ischemic heart disease.\n13. Have Wolff-Parkinson-White syndrome or any other accessory pathway that has not been successfully eliminated by ablation.\n14. Have a history of arrhythmia, other than premature atrial contractions (PACs) or occasional PVCs in the absence of ischemic heart disease, within 12 months of screening.\n\n    Participants with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia or any other arrhythmia associated with a bypass tract may be enrolled only if they have been successfully treated with ablation and have not had recurrent arrhythmia for at least one year off all antiarrhythmic drugs, and confirmed by a cardiologist.\n15. Have evidence or history of significant (controlled or uncontrolled) hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, renal, gastrointestinal, immunocompromising, or neurological disease, including seizure disorder, or any other medical disorder judged by the investigator to significantly increase the risk of MDMA administration (participants with hypothyroidism who are on adequate and stable thyroid replacement will not be excluded). Note: if participants present with a history of glaucoma, enrollment would be allowed only with the approval of their ophthalmologist\n16. Have uncontrolled hypertension using the standard criteria of the American Heart Association (values of 140\u002F90 milligrams of Mercury \\[mmHg\\] or higher assessed on three separate occasions)\n17. Have a heart rate \\> 100 bpm on three separate occasions\n18. Have a marked Baseline prolongation of QT\u002FQTc interval (For purposes of eligibility, this is defined as repeated demonstration of a QT interval corrected using Fridericia's formula \\[QTcF\\] \\>450 milliseconds \\[ms\\] and \\>460 ms in females. For transgender or non-binary participants, QTc interval will be evaluated based on sex assigned at birth, unless the participant has been on hormonal treatment for five or more years.\n19. Have a history of additional risk factors for Torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)\n20. Require use of concomitant medications that prolong the QT\u002FQTc interval during Experimental Sessions. Refer to Section 12.0 Concomitant Medications.\n21. Have symptomatic liver disease\n22. Have history of hyponatremia or hyperthermia\n23. Are pregnant, nursing, or able to become pregnant and are not practicing an effective means of birth control.\n24. Have hypersensitivity to any ingredient of the IMP (Investigational Medicinal Product).",{"count":71,"type":20},20,[23],"The goal of this clinical trial is to assess feasibility, tolerability and preliminary effectiveness of MDMA-assisted therapy for adjustment disorder (AD) in 10 dyads of patients with cancer and a concerned significant other (CSO) (20 participants total).\n\nParticipants will undergo an 8-week treatment period which will include two doses of MDMA, two Preparatory Sessions and four Integrative Sessions of non-drug therapy.",[75,76],"Cancer","Adjustment Disorders","2026-04-28",{"date":79,"type":31},"2026-05-04",{"date":81,"type":31},"2022-10-06",{"date":83,"type":20},"2028-11",{"name":36,"class":37},""]