[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07685964":3,"trial-entities:NCT07685964":135,"trial-summary:NCT07685964":139},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":21,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":33,"interventions":36,"primary_outcomes":43,"secondary_outcomes":48,"sex":56,"minimum_age":57,"maximum_age":58,"healthy_volunteers":59,"eligibility_criteria":60,"std_ages":80,"locations":82,"central_contacts":119,"overall_officials":122,"references":124,"see_also_links":134},"NCT07685964","STU20260979","Pregnenolone for Cannabis Use Disorder and Depression","Advancing Pregnenolone as a Novel Therapy for Co-Occurring Cannabis Use Disorder and Depression","NOT_YET_RECRUITING","2028-08","2026-06","2026-07-06","2026-09","University of Texas Southwestern Medical Center","OTHER",true,"This is UG3 phase of a multi-site, milestone-driven UG3\u002FUH3 research program evaluating pregnenolone for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms.\n\nThe primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug \\[IND\\] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems.\n\nThe UG3 phase includes two main components. First, a pharmacokinetic study willcharacterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates.\n\nParticipants will be adults aged 18 to 50 years with diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected.\n\nThe UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.","This study represents the UG3 phase of a multi-site, milestone-driven UG3\u002FUH3 research program evaluating pregnenolone as a novel pharmacotherapy for individuals with co-occurring cannabis use disorder (CUD) and major depressive disorder (MDD). Pregnenolone is a neurosteroid that modulates cannabinoid receptor signaling and may reduce cannabis-related effects while also improving mood-related symptoms.\n\nThe primary objective of the UG3 phase is to establish feasibility and generate preliminary data to support a subsequent UH3 randomized clinical trial. Key preparatory activities include obtaining regulatory approvals (including FDA Investigational New Drug \\[IND\\] protocol amendment and Institutional Review Board approvals), harmonizing study procedures across participating sites, and implementing data management and monitoring systems.\n\nThe UG3 phase includes two main components. First, a pharmacokinetic study will be conducted to characterize pregnenolone pharmacokinetics in adults with CUD and MDD, including measures such as half-life and clearance. Second, a pilot clinical study will evaluate the feasibility, safety, and tolerability of pregnenolone administered orally over approximately 12 weeks. Feasibility outcomes include recruitment rates, retention, and adherence to study procedures, while safety and tolerability will be assessed through adverse event monitoring and discontinuation rates.\n\nParticipants will be adults aged 18 to 50 years with DSM-5 diagnoses of cannabis use disorder and major depressive disorder, who report frequent cannabis use and express interest in reducing their use. Standardized clinical assessments of cannabis use, mood symptoms, and related behavioral outcomes will be collected.\n\nData obtained during the UG3 phase will be used to refine study procedures, inform dosing strategies, and establish benchmarks necessary for progression to the UH3 phase. The subsequent UH3 phase will involve a multi-site, randomized, double-blind, placebo-controlled trial evaluating the efficacy of pregnenolone in reducing cannabis use and improving depressive symptoms in this population.",[19,20],"Cannabis Use Disorder","Major Depressive Disorder (MDD)",[22,23,24,25,26,27],"Pregnenolone","Cannabis Use","Depression","Neurosteroid","Pharmacokinetics","Feasibility Study","INTERVENTIONAL","TREATMENT",[31,32],"PHASE1","PHASE2",{"count":34,"type":35},20,"ESTIMATED",[37],{"type":38,"name":22,"description":39,"armGroupLabels":40},"DRUG","Pregnenolone is a neurosteroid administered orally. It is being studied for its pharmacokinetics, safety, tolerability, and feasibility in adults with cannabis use disorder and major depressive disorder.",[41,42],"Pregnenolone 300mg\u002Fd","Pregnenolone 500mg\u002Fd",[44],{"measure":45,"description":46,"timeFrame":47},"Percent Days of Cannabis Use","The Timeline Follow Back (TLFB) interview will be used to assess cannabis use. The percent days of cannabis use will be the primary outcome measure.","12 weeks",[49,53],{"measure":50,"description":51,"timeFrame":52},"Depressive Symptom Severity","The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used 10-item observer-rated measure of depressive symptomatology designed for use in clinical trials.","12 Weeks",{"measure":54,"description":55,"timeFrame":52},"Marijuana Craving","The Marijuana Craving Questionnaire (MCQ) will be used to assess marijuana craving at each study visit. The MCQ was adapted from a valid tobacco craving questionnaire and has proven to be useful in previous marijuana (MJ) studies. This measure will be used to determine subjective craving.","ALL","18 Years","50 Years",false,{"inclusion":61,"exclusion":70,"raw_text":79},[62,63,64,65,66,67,68,69],"Adults aged 18 to 50 years","Diagnosis of cannabis use disorder according to DSM-5 criteria","Diagnosis of major depressive disorder according to DSM-5 criteria","Cannabis use on at least 4 days per week in the past 4 weeks","Positive urine screen for tetrahydrocannabinol (THC)","Willingness to reduce cannabis use","Medication-free or on a stable dose of antidepressant medication","Able to provide informed consent",[71,72,73,74,75,76,77,78],"Current diagnosis of other substance use disorders (except nicotine)","Current or past diagnosis of psychotic disorders, bipolar disorder, or severe psychiatric conditions","Significant or unstable medical conditions that would interfere with study participation","Pregnant or breastfeeding","Active suicidal or homicidal ideation requiring immediate intervention","Use of medications that may interfere with study drug or outcomes, unless stable","Allergy or sensitivity to pregnenolone or related compounds","History of hormone-sensitive cancer or tumor","Inclusion Criteria:\n\n* Adults aged 18 to 50 years\n* Diagnosis of cannabis use disorder according to DSM-5 criteria\n* Diagnosis of major depressive disorder according to DSM-5 criteria\n* Cannabis use on at least 4 days per week in the past 4 weeks\n* Positive urine screen for tetrahydrocannabinol (THC)\n* Willingness to reduce cannabis use\n* Medication-free or on a stable dose of antidepressant medication\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* Current diagnosis of other substance use disorders (except nicotine)\n* Current or past diagnosis of psychotic disorders, bipolar disorder, or severe psychiatric conditions\n* Significant or unstable medical conditions that would interfere with study participation\n* Pregnant or breastfeeding\n* Active suicidal or homicidal ideation requiring immediate intervention\n* Use of medications that may interfere with study drug or outcomes, unless stable\n* Allergy or sensitivity to pregnenolone or related compounds\n* History of hormone-sensitive cancer or tumor",[81],"ADULT",[83,101],{"facility":84,"city":85,"state":86,"zip":87,"country":88,"contacts":89,"geoPoint":98},"UT Southwestern Medical Center","Dallas","Texas","75390","United States",[90,95],{"name":91,"role":92,"phone":93,"email":94},"E. Sherwood Brown","CONTACT","214-645-6950","SHERWOOD.BROWN@UTSouthwestern.edu",{"name":96,"role":92,"email":97},"Reagan Volzer","Reagan.Volzer@UTSouthwestern.edu",{"lat":99,"lon":100},32.78306,-96.80667,{"facility":102,"city":103,"state":86,"zip":104,"country":88,"contacts":105,"geoPoint":116},"University of Texas at Dallas","Richardson","75080",[106,110,114],{"name":107,"role":92,"phone":108,"email":109},"Francesca Filbey","972-883-2313","francesca.filbey@utdallas.edu",{"name":111,"role":92,"phone":112,"email":113},"Aishwarya Veerkumar","972-742-5842","aishwarya.veerkumar@utdallas.edu",{"name":107,"role":115},"PRINCIPAL_INVESTIGATOR",{"lat":117,"lon":118},32.94818,-96.72972,[120,121],{"name":91,"role":92,"phone":93,"email":94},{"name":107,"role":92,"phone":108,"email":109},[123],{"name":91,"affiliation":13,"role":115},[125,128,131],{"type":126,"citation":127},"BACKGROUND","Mason BJ, Mustafa A, Filbey FM, Brown ES. Novel pharmacotherapeutic interventions for cannabis use disorders. Current Addiction Reports. 2016.",{"pmid":129,"type":126,"citation":130},"20493557","Osuji IJ, Vera-Bolanos E, Carmody TJ, Brown ES. Pregnenolone for cognition and mood in dual diagnosis patients. Psychiatry Res. 2010 Jul 30;178(2):309-12. doi: 10.1016\u002Fj.psychres.2009.09.006. Epub 2010 May 21.",{"pmid":132,"type":126,"citation":133},"24917198","Brown ES, Park J, Marx CE, Hynan LS, Gardner C, Davila D, Nakamura A, Sunderajan P, Lo A, Holmes T. A randomized, double-blind, placebo-controlled trial of pregnenolone for bipolar depression. Neuropsychopharmacology. 2014 Nov;39(12):2867-73. doi: 10.1038\u002Fnpp.2014.138. Epub 2014 Jun 11.",[],{"nct_id":4,"conditions":136,"biomarkers":138},[19,137],"Unipolar Depression",[],{"nct_id":4,"found":15,"summary":140,"prompt_version":149},{"design":141,"status":142,"heading":6,"summary":143,"follow_up":144,"word_count":145,"commitments":146,"compensation":147,"drugs_mentioned":148},"This is an interventional study with a planned enrollment of 20 participants. It is the first part of a larger research program.","completed","This study is looking at an oral medication called Pregnenolone for adults who have both cannabis use disorder and major depressive disorder. Pregnenolone is a neurosteroid, which means it's a natural chemical in the brain that might help reduce the effects of cannabis and improve mood. We want to see how the body handles Pregnenolone, if it's safe, and if people can tolerate taking it. To join, you need to be between 18 and 50 years old, have both conditions, use cannabis at least 4 days a week, and be willing to reduce your cannabis use. The main goal is to see how many days you use cannabis over 12 weeks.","The primary outcome, percent days of cannabis use, is measured at 12 weeks.",111,"You would take Pregnenolone orally for about 12 weeks. The study will also look at how your body processes the medication.","Not stated in the trial record.",[22],"v2"]