[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07225777":3,"trial-entities:NCT07225777":111,"trial-summary:NCT07225777":114},{"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":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":43,"secondary_outcomes":52,"sex":66,"minimum_age":67,"maximum_age":68,"healthy_volunteers":69,"eligibility_criteria":70,"std_ages":88,"locations":90,"central_contacts":105,"overall_officials":106,"references":109,"see_also_links":110},"NCT07225777","Pro00148223","Sex Differences in Neurobehavioral Response to THC","Sex Differences in Neurobehavioral Response to Acute THC in Adults With Cannabis Use Disorder","RECRUITING","2027-12-31","2026-05","2026-05-06","2026-04-27","Medical University of South Carolina","OTHER",true,"This study investigates sex differences in reward processing following acute THC administration in adults with cannabis use disorder (CUD). Using multimodal neuroimaging (MRS and fMRI), the study will assess glutamate levels in the nucleus accumbens and striatal BOLD response to monetary reward anticipation. Participants will complete two counterbalanced dosing sessions (oral THC 40 mg vs. placebo).",null,[19],"Cannabis Use Disorder",[21],"Substance Use","INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE2",{"count":27,"type":28},40,"ESTIMATED",[30,39],{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":37},"DRUG","Dronabinol","Oral dronabinol capsules (40 mg)",[35,36],"Females","Males",[38],"Marinol",{"type":31,"name":40,"description":41,"armGroupLabels":42},"Placebo","Matched placebo capsules",[35,36],[44,48],{"measure":45,"description":46,"timeFrame":47},"Nucleus accumbens glutamate","Concentrations of nucleus accumbens glutamate measured via proton magnetic resonance spectroscopy","2 hours post-dose",{"measure":49,"description":50,"timeFrame":51},"Striatal reward anticipation","Blood oxygen-level-dependent (BOLD) signaling in the striatum (caudate, putamen, nucleus accumbens) measured using functional magnetic resonance imaging (fMRI) during a monetary reward task","3 hours post-dose",[53,57,60,63],{"measure":54,"description":55,"timeFrame":56},"Drug Effects Questionnaire (DEQ) - Like Drug Effect","Visual Analog Scale rating of subjective drug liking included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none\u002Fextreme designation.","0-7 hours",{"measure":58,"description":59,"timeFrame":56},"Drug Effects Questionnaire (DEQ) - Want More","Visual Analog Scale rating of subjective desire for more of the same drug included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none\u002Fextreme designation.",{"measure":61,"description":62,"timeFrame":56},"Drug Effects Questionnaire (DEQ) - High","Visual Analog Scale rating of subjective \"high\" included in the Drug Effects Questionnaire. Score ranges from 0 (not at all) to 100 (extremely) using a 100mm line anchored with none\u002Fextreme designation.",{"measure":64,"description":65,"timeFrame":47},"Nucleus accumbens GABA","Concentrations of nucleus accumbens GABA measured via proton magnetic resonance spectroscopy","ALL","21 Years","45 Years",false,{"inclusion":71,"exclusion":79,"raw_text":87},[72,73,74,75,76,77,78],"Age 21-45","DSM-5 criteria for CUD","Cannabis use ≥4 days\u002Fweek","THC-positive urine","BMI 18-30","Regular menstrual cycle (females)","Willingness to use non-hormonal birth control (females)",[80,81,82,83,84,85,86],"Lifetime psychotic or bipolar disorder","Recent drug use other than cannabis","Current psychotropic medication","Treatment-seeking for SUD","Current psychiatric disorder (except mild alcohol, nicotine, or caffeine use disorder)","Pregnancy\u002Fnursing","MRI contraindications","Inclusion Criteria:\n\n* Age 21-45\n* DSM-5 criteria for CUD\n* Cannabis use ≥4 days\u002Fweek\n* THC-positive urine\n* BMI 18-30\n* Regular menstrual cycle (females)\n* Willingness to use non-hormonal birth control (females)\n\nExclusion Criteria:\n\n* Lifetime psychotic or bipolar disorder\n* Recent drug use other than cannabis\n* Current psychotropic medication\n* Treatment-seeking for SUD\n* Current psychiatric disorder (except mild alcohol, nicotine, or caffeine use disorder)\n* Pregnancy\u002Fnursing\n* MRI contraindications",[89],"ADULT",[91],{"facility":13,"status":8,"city":92,"state":93,"zip":94,"country":95,"contacts":96,"geoPoint":102},"Charleston","South Carolina","29403","United States",[97],{"name":98,"role":99,"phone":100,"email":101},"Erin Martin, Ph.D.","CONTACT","843-876-3528","marterin@musc.edu",{"lat":103,"lon":104},32.77632,-79.93275,[],[107],{"name":98,"affiliation":13,"role":108},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":112,"biomarkers":113},[19,21],[],{"nct_id":4,"found":15,"summary":115,"prompt_version":125},{"design":116,"status":117,"heading":118,"summary":119,"follow_up":120,"word_count":121,"commitments":122,"compensation":123,"drugs_mentioned":124},"This is an interventional study with 40 planned participants. It compares the effects of dronabinol to a placebo.","completed","Sex Differences in Neurobehavioral Response to THC in Cannabis Use Disorder","This study is looking at how men and women with cannabis use disorder (CUD) respond differently to THC, the main active ingredient in cannabis. You might be able to join if you are 21-45 years old, have CUD, and use cannabis at least four days a week. The study will test oral dronabinol capsules (a form of THC) against a placebo (an inactive pill). Researchers will measure brain chemicals (glutamate) and brain activity related to reward anticipation to see if there are differences between sexes after taking dronabinol. The goal is to understand how THC affects the brain's reward system in people with CUD, and if these effects differ between men and women. The study is currently recruiting participants.","Brain chemical levels are measured at 2 hours post-dose, and brain activity is measured at 3 hours post-dose.",119,"You will complete two study sessions where you receive either dronabinol or a placebo. During these sessions, you will undergo brain imaging tests.","Not stated in the trial record.",[32,40],"v2"]