[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100567782":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":31,"locations":37,"responsibleParty":59,"collaborators":30,"id":61,"slug":30,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":30,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":30,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":81,"overallStatus":39,"whyStopped":30,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Hemp Derived Cannabidiol Extract","EXPERIMENTAL","SunFlora's CBD Extract 50mg to 150mg titrated over 4 weeks",[13],"Drug: Hemp Derived Cannabidiol Extract",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Placebo substance to reflect same consistency as the experimental drug",[19],"Drug: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Participants will be given the study drug in a titrated method of 50-150mgs per day for 4 weeks",[9],[26],"SunFlora CBD Extract",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Partcipants will be given placebo substance to be taken with titrated instructions that mimic IP dispensing method daily for 4 weeks",[15],null,[32],{"name":33,"role":34,"phone":35,"phoneExt":30,"email":36},"Robyn R Nelson","CONTACT","3522945563","r.nelson@ufl.edu",[38],{"facility":5,"status":39,"city":40,"state":41,"zip":42,"country":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Gainesville","Florida","32611","United States",{"type":45,"coordinates":46},"Point",[47,48],-82.32483,29.65163,{"lat":48,"lon":47},[51,53,56],{"name":33,"role":34,"phone":52,"phoneExt":30,"email":36},"352-294-5564",{"name":54,"role":55,"phone":30,"phoneExt":30,"email":30},"Catalina Lopez-Quintero, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":57,"role":58,"phone":30,"phoneExt":30,"email":30},"Carol A Mathews, M.D.","SUB_INVESTIGATOR",{"type":60,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100567782",false,"NCT06672666","Use of CBD in the Treatment of Anxiety","A Pilot Double-Blind Placebo-Controlled, Randomized, Safety, Efficacy, and Acceptability Trial of a Hemp-Derived Cannabidiol Extract for the Treatment of Anxiety","Inclusion Criteria:\n\n* Any biological sex and ages 18 to 55 years old\n* Willing and able to give informed consent for participation in the study\n* Willing and able to comply with all study requirements, including willingness to donate blood during the study\n* Meet diagnosis for moderate to severe anxiety based on a score of more than 14 in the Hamilton Anxiety Rating Scale (HAM-A)\n* Subjects of childbearing potential should use two forms of highly effective contraception methods combined (e.g., barrier methods combined with Long-Acting Reversible Contraceptives) to be eligible for study participation.\n* Normal clinical history and laboratory test\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Any history of suicidal behavior or any suicidal ideation in the past six months or at screening\n* Any change in current SSRI, SNRI, or other non-benzo anxiolytic medication within six weeks of baseline visit.\n* Active daily or almost daily (3+ days\u002Fweek) use of cannabinoids or THC in the past month or any other illicit drug within the past 6 months\n* Inability to refrain from using alcohol (4 or more drinks in one occasion or 3+ days\u002Fweek), antiepileptics, antipsychotics, oral antifungals, verapamil, nitrofurantoin, or any other medication in drug classes, such as antibiotics, nonsteroidal anti-inflammatory drugs, herbal and dietary supplements, cardiovascular drugs, central nervous system agents, or antineoplastic drugs, inducing transaminase elevation based on the LiverTox database. 17,18\n* Inability to adjust the doses of prescription medications displaying a narrow therapeutic index that are potentially impacted by concomitant cannabinoid use18,19.\n* Inability to refrain from using acetaminophen, or topic antifungals on a regular basis (more than two times per week) over the course of the trial.\n* Active use of benzodiazepines, opioids, and antihistamines or any other medication inducing lethargy and sedation, except for antidepressants, for which detailed information will be collected.\n* History of liver disease or current liver disease or clinically significant elevation in serum liver chemistries at baseline (i.e., Serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\>3 times upper limit of normal (ULN) or alkaline phosphatase (ALP) \\>2 times ULN (or the baseline value if baseline is elevated); Total serum bilirubin \\>2.5 mg\u002FdL with elevated AST, ALT or ALP; or International normalized ratio (INR) \\>1.5 with elevated AST, ALT or ALP).20\n* Current substance use disorder\n* Unstable medical or neurological condition\n* Positive drug screen for substances of abuse\n* Lifetime history of psychotic disorder, bipolar disorder, PTSD or OCD\n* Psychotherapy newly instituted during the 6 weeks leading up to enrollment in the study. Subjects established in psychotherapy without change during the course of the study may participate.\n* Severe depression symptoms in the past six months.\n* Known or suspected hypersensitivity to cannabidiol or any other components in the extract.","ALL","18 Years","55 Years",{"count":71,"type":72},30,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","This study will examine the doses, safety, and test the preliminary efficacy of hemp-derived CBD product for improving anxiety symptoms and sleep disturbances among individuals with anxiety. A 4-week, randomized, double-blind, placebo-controlled trial will be conducted to determine the safety, tolerability, preliminary efficacy, and acceptability of 50 to 150 mg\u002Fday of CBD. The treatment period will consist of a two-week titration period followed by a 2- week maintenance period. In addition, the study seeks to examine whether changes in sleep disturbances precede changes in anxiety symptoms.",[78,79,80],"Anxiety","Generalized Anxiety Disorder","Sleep Problems",[78,82,83,84,79,85,86],"CBD","Cannabidiol","Hemp-Derived Cannabidiol Extract","GAD","sleep","2025-01-31",{"date":89,"type":90},"2025-02-03","ACTUAL",{"date":92,"type":90},"2025-01-06",{"date":94,"type":72},"2026-12-01",{"name":5,"class":6},1]