[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100602435":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":52,"centralContacts":61,"locations":69,"responsibleParty":91,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":42,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":119,"overallStatus":72,"whyStopped":42,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Wayne State University","OTHER",[8,14,19,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Brief Cognitive Behavioral Therapy + Moderate-Dose Cannabidiol","EXPERIMENTAL","Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with oral cannabidiol (EPIDIOLEX®) at a moderate dose. Dosing starts at 5 milligram\u002Fkilogram\u002Fday and titrates to 10 milligram\u002Fkilogram\u002Fday (divided twice a day) after 6 days. Cannabidiol is administered chronically throughout CBT to examine target engagement and symptom outcomes.",[13],"Drug: Moderate-Dose Cannabidiol",{"label":15,"type":10,"description":16,"interventionNames":17},"Brief Cognitive Behavioral Therapy + Low-Dose Cannabidiol","Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a lower dose of oral cannabidiol (EPIDIOLEX®), maintained at 5 milligram\u002Fkilogram\u002Fday (divided twice a day) throughout the treatment period. No titration is required.",[18],"Drug: Low-Dose Cannabidiol",{"label":20,"type":21,"description":22,"interventionNames":23},"Brief Cognitive Behavioral Therapy + Placebo Titrated to Match Moderate-Dose Cannabidiol","PLACEBO_COMPARATOR","Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a matched placebo oral solution. The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the moderate dose cannabidiol arm, dosing starts at 5 milligram\u002Fkilogram\u002Fday and titrates to 10 milligram\u002Fkilogram\u002Fday (divided twice a day) after 6 days.",[24],"Drug: Placebo Matched to Moderate-Dose Cannabidiol",{"label":26,"type":21,"description":27,"interventionNames":28},"Brief Cognitive Behavioral Therapy + Placebo Titrated to Match Low-Dose Cannabidiol","Participants will receive a 5-week course of brief cognitive behavioral therapy (CBT) combined with a matched placebo oral solution. The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the low-dose cannabidiol arm, dosing is maintained at 5 milligram\u002Fkilogram\u002Fday (divided twice a day) throughout the treatment period. No titration is required.",[29],"Drug: Placebo Matched to Low-Dose Cannabidiol",[31,38,43,48],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DRUG","Low-Dose Cannabidiol","Oral cannabidiol solution (EPIDIOLEX®) administered as an adjunct to cognitive behavioral therapy. Low-dose participants receive 5 milligram\u002Fkilogram\u002Fday throughout. The intervention targets emotion regulation circuitry and symptom improvement.",[15],[37],"EPIDIOLEX®",{"type":32,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"Placebo Matched to Moderate-Dose Cannabidiol","The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the moderate-dose cannabidiol arm, dosing starts at 5 mg\u002Fkg\u002Fday and titrates to 10 milligram\u002Fkilogram\u002Fday (divided twice a day) after 6 days.",[20],null,{"type":32,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Moderate-Dose Cannabidiol","Oral cannabidiol solution (EPIDIOLEX®) administered as an adjunct to cognitive behavioral therapy. Moderate-dose participants receive 5 milligram\u002Fkilogram\u002Fday for 6 days, then titrate to 10 milligram\u002Fkilogram\u002Fday. The intervention targets emotion regulation circuitry and symptom improvement.",[9],[37],{"type":32,"name":49,"description":50,"armGroupLabels":51,"otherNames":42},"Placebo Matched to Low-Dose Cannabidiol","The placebo mimics the appearance, smell, and taste of EPIDIOLEX®. For blinding the low-dose cannabidiol arm, dosing is maintained at 5 milligram\u002Fkilogram\u002Fday (divided twice a day) throughout the treatment period. No titration is required.",[26],[53,56,59],{"name":54,"affiliation":5,"role":55},"Hilary Marusak, PhD","PRINCIPAL_INVESTIGATOR",{"name":57,"affiliation":58,"role":55},"Christine Rabinak, PhD, MBA","Wayne State Universty",{"name":60,"affiliation":5,"role":55},"Leslie Lundahl, PhD",[62,66],{"name":54,"role":63,"phone":64,"phoneExt":42,"email":65},"CONTACT","(313) 577-1278","hmarusak@med.wayne.edu",{"name":57,"role":63,"phone":67,"phoneExt":42,"email":68},"(313) 577-9875","rabinak@wayne.edu",[70],{"facility":71,"status":72,"city":73,"state":74,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"Wayne State University School of Medicine, Tolan Park Medical Building","RECRUITING","Detroit","Michigan","48201","United States","US",{"type":79,"coordinates":80},"Point",[81,82],-83.04575,42.33143,{"lat":82,"lon":81},[85,86,89,90],{"name":54,"role":63,"phone":64,"phoneExt":42,"email":65},{"name":60,"role":63,"phone":87,"phoneExt":42,"email":88},"(313) 993-1374","llundahl@med.wayne.edu",{"name":54,"role":55,"phone":42,"phoneExt":42,"email":42},{"name":60,"role":55,"phone":42,"phoneExt":42,"email":42},{"type":55,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":42,"oldOrganization":42},"Hilary Marusak","Associate Professor, Department of Psychiatry and Behavioral Neuroscience",[95],{"name":96,"class":97},"National Institute of Mental Health (NIMH)","NIH","100602435","phase-3-cannabidiol-assisted-learning-for-managing-generalized-anxiety-disorder-100602435",false,"NCT07123467","Cannabidiol-Assisted Learning for Managing Generalized Anxiety Disorder","Cannabidiol-Enhanced Cognitive Behavioral Therapy for Generalized Anxiety Disorder","CALM","Inclusion Criteria:\n\n* Right-handed\n* Age 18-45 years at enrollment\n* Able to consent to the study\n* Agree to adhere to lifestyle considerations throughout study duration\n* Generally medically and neurologically healthy, including no evidence of intellectual disability or serious cognitive impairment\n* Have a current generalized anxiety disorder (GAD) diagnosis according to the The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria and\u002For total scores ≥ 8 on the 7-Item Generalized Anxiety Disorders Scale (GAD-7)\n\nExclusion Criteria:\n\n* Clinically significant medical or neurologic condition or neurocognitive dysfunction that would affect function and\u002For task performance and\u002For interfere with the study protocol\n* Any current (or within past 2 months) medical condition requiring medication that would interact with cannabidiol or interfere with the study protocol\n* Risk of harm to self or others that requires immediate intervention\n* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to cannabinoid-like substances or components of EPIDIOLEX®\n* Positive drug screen or alcohol breathalyzer\n* Unwilling\u002Funable to sign informed consent document\n* Currently pregnant (positive pregnancy test), planning pregnancy, or lactating (women),\n* Under 18 or over 45 years of age\n* Traumatic brain injury, as defined by The American Congress of Rehabilitation as a person who has had a traumatically induced physiological disruption of brain function (i.e., the head being struck, the head striking an object, and\u002For the brain undergoing an acceleration\u002Fdeceleration movement \\[i.e., whiplash\\] without direct external trauma to the head), as manifested by at least one of the following: any loss of consciousness; any loss of memory for events immediately before or after the injury; any alteration in mental status at the time of the incident; or focal neurological deficits that may or may not be transient)\n* Inability to tolerate small, enclosed spaces without anxiety (e.g. claustrophobia), as determined by self-report and\u002For a preliminary session in a mock scanner\n* Presence of ferrous-containing metals within the body (e.g., aneurysm clips, shrapnel\u002Fretained particles)\n* Receiving concurrent psychotherapy or have received psychotherapy, including for research purposes, within the past year\n* Current moderate or severe alcohol\u002Fdrug use disorder or in the past 8 weeks\n* Current or past diagnosis of bipolar and other related disorders, schizophrenia spectrum, or other psychotic disorders;\n* GAD-7 score \\\u003C 8\n* Use of medications known to have severe drug interactions with cannabidiol or that are strong inducers of cytochrome P450 3A4 (CYP3A4) or cytochrome P450 2C19 (CYP2C19)\n* Visual impairment\n* Baseline labs 3 times outside of normal range\n* Use of as needed anti-anxiety medications (e.g., benzodiazepines), unstable dose of other psychoactive drug (i.e., \\\u003C 4 weeks), or intention to start new treatment during this trial\n* Current or past-month use of cannabis, or a tetrahydrocannabinol (THC) or cannabidiol-containing product (self-report and urine drug screen)\n* Current or past-month coronavirus disease 2019 (COVID-19) diagnosis or febrile illness\n* Treatment with another investigational drug or intervention within the past month\n* Difficulty with or inability to comply with the complete clinical trial.","ALL","18 Years","45 Years",{"count":110,"type":111},90,"ESTIMATED","INTERVENTIONAL",[114],"PHASE3","This randomized, double-blind, placebo-controlled clinical trial investigates the use of Food and Drug Administration (FDA)-approved cannabidiol (EPIDIOLEX®) as an adjunct to cognitive behavioral therapy (CBT) in adults with generalized anxiety disorder (GAD). The study aims to evaluate whether cannabidiol-assisted CBT enhances emotion regulation via dorsomedial prefrontal cortex (dmPFC) activation and improves anxiety symptom outcomes compared to CBT with placebo.",[117,118],"Generalized Anxiety Disorder (GAD)","Anxiety Disorders",[120,121,122,123,124],"Cannabidiol","EPIDIOLEX","Cognitive Behavioral Therapy","Generalized Anxiety Disorder","functional magnetic resonance imaging","2026-03-06",{"date":127,"type":128},"2026-03-09","ACTUAL",{"date":130,"type":128},"2025-11-03",{"date":132,"type":111},"2027-08-31",{"name":5,"class":6},1]