[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100533165":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":48,"centralContacts":49,"locations":57,"responsibleParty":75,"collaborators":48,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":48,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":99,"overallStatus":101,"whyStopped":48,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Wayne State University","OTHER",[8,14,19,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo (PBO) only","PLACEBO_COMPARATOR","In a double-blind, placebo and active-controlled, between-subjects design, the investigators will administer drugs containing THC (2.5mg), CBD (2.5mg) or PBO (0mg THC\u002FCBD). Drug is administered and smoked immediately prior to exposure therapy sessions 3-6. 70 participants will be randomly assigned to each treatment arm. All participants will receive prolonged exposure therapy.",[13],"Drug: Placebo only",{"label":15,"type":16,"description":11,"interventionNames":17},"Cannabidiol (CBD) only","EXPERIMENTAL",[18],"Drug: Cannabidiol (CBD) only",{"label":20,"type":16,"description":11,"interventionNames":21},"Delta-9-tetrahydrocannabinol (THC) only",[22],"Drug: Delta-9-tetrahydrocannabinol (THC) only",{"label":24,"type":16,"description":11,"interventionNames":25},"THC:CBD 1:1",[26],"Drug: THC:CBD 1:1",[28,34,40,44],{"type":29,"name":15,"description":30,"armGroupLabels":31,"otherNames":32},"DRUG","Cannabis consisting of 2.5mg CBD and 0mg Delta-9-tetrahydrocannabinol (THC) is administered via smoking.",[15],[33],"Cannabis",{"type":29,"name":35,"description":36,"armGroupLabels":37,"otherNames":38},"Placebo only","Placebo is administered via smoking in the same way as active drugs. Placebo cannabis material obtained through National Institute of Drug Abuse (NIDA) contains 0mg THC and 0mg CBD",[9],[39],"Sugar Pill",{"type":29,"name":20,"description":41,"armGroupLabels":42,"otherNames":43},"Cannabis containing 2.5mg THC and 0mg CBD is administered via smoking.",[20],[33],{"type":29,"name":24,"description":45,"armGroupLabels":46,"otherNames":47},"Cannabis containing 2.5mg of THC and 2.5mg of CBD is administered via smoking.",[24],[33],null,[50,55],{"name":51,"role":52,"phone":53,"phoneExt":48,"email":54},"Paula Qefaliaj","CONTACT","(313) 993-1374","paulaq@wayne.edu",{"name":56,"role":52,"phone":53,"phoneExt":48,"email":48},"Leslie Lundahl, PhD",[58],{"facility":59,"status":48,"city":60,"state":61,"zip":62,"country":63,"countryCode":64,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Tolan Park Medical Building","Detroit","Michigan","48201","United States","US",{"type":66,"coordinates":67},"Point",[68,69],-83.04575,42.33143,{"lat":69,"lon":68},[72],{"name":56,"role":52,"phone":73,"phoneExt":48,"email":74},"313-993-3964","llundahl@med.wayne.edu",{"type":76,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":48,"oldOrganization":48},"PRINCIPAL_INVESTIGATOR","Christine Rabinak, PhD","Professor","100533165","phase-1-wayne-state-warriors-marijuana-clinical-research-program-cannabinoid-adjunct-to-prolonged-exposure--recovery-100533165",false,"NCT06222268","Wayne State Warriors Marijuana Clinical Research Program: Cannabinoid Adjunct to Prolonged Exposure & Recovery","CAPER","Inclusion Criteria:\n\n* Willing and able to consent to the study\n* Agree to comply with requirements and procedures\n* Veteran who has served in a branch of the US armed forces\n* Between ages 18-60\n* Report using cannabis within the past three years but not more than twice in the past month\n* Exposure to Criterion A stressor defined by CAPS-5 and identified by Life Events Checklist-5 (LEC-5); trauma does not have to be related to combat or military service\n* Significant PTSD severity as indicated by CAPS-5 diagnosis and\u002For score \\>= 25 of at least one month prior to study entry, PTSD is patient's primary concern\n* not currently receiving any psychotherapy for PTSD\n\nExclusion Criteria:\n\n* Pregnant, lactating or are a heterosexually active, pre-menopausal woman who is NOT using medically approved birth control (e.g., oral or depot contraception, contraceptive implant, IUD, condom\u002Ffoam, sterilization, tubal ligation)\n* Current or past diagnosis of any bipolar or related disorder or schizophrenia spectrum and other psychotic disorder as determined by the SCID-5 or previous diagnosis by a licensed psychologist or psychiatrist\n* Determined to be at high risk for suicide requiring immediate intervention based on the C-SSRS and\u002For clinician judgment\n* Meet criteria for substance use disorder other than Cannabis Use Disorder or Alcohol (Mild or Moderate) or Nicotine Use Disorder, determined by the SCID-5\n* Presence of contraindications, current or past allergic or adverse reaction, or known sensitivity to smoking cannabis\n* Concomitant treatment with medication taken daily that has level 1 evidence indicating severe drug-drug interactions with cannabis\n* Currently receiving psychotherapy for PTSD or previously received exposure-based PTSD treatment\n* Current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, systemic, pulmonary, pulmonary fibrosis, or other forms of restrictive lung disease, immunocompromising, or neurological disease\n* Current diagnosis of a mood, anxiety, or other disorder that is more clinically salient than PTSD\n* Cognitive exhibit impairment\n* Lack of fluency in English\n* Insufficient memory of the index traumatic event\n* Pervasive development disorder history\n* Seeking or currently undergoing treatment for Cannabis Use Disorder.\n* Traumatic brain injury (TBI) with current cognitive impairment related to TBI\n* Exclusively left-handed (score of -100 on Handedness Questionnaire)\n* claustrophobic\n* MRI contraindications (e.g., ferrous metal in head\u002Fbody)","ALL","18 Years","60 Years",{"count":90,"type":91},280,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","The overall strategy is to recruit veterans with PTSD who report minimal current cannabis use but are interested in or considering therapeutic cannabis to manage mental health symptoms (anxiety, depression, PTSD and\u002For suicidality). The information gained from this study could lead to the development of new treatments for persons who suffer from post-traumatic stress disorder and maintain better mental health.",[97,98],"PTSD","Post Traumatic Stress Disorder",[100],"Veterans","NOT_YET_RECRUITING","2026-01-29",{"date":104,"type":105},"2026-02-03","ACTUAL",{"date":107,"type":91},"2026-03",{"date":109,"type":91},"2031-09",{"name":5,"class":6},1]