[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Joshua A. Lile, Ph.D.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":64},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":4},"100526639","phase-2-cannabis-for-obesity-trial-100526639",false,"NCT06137365","Cannabis for Obesity Trial","A Randomized, Placebo-Controlled Clinical Trial of Once Daily Oral Cannabis for Weight Loss in Obese Individuals","Inclusion Criteria\n\n* Male or female.\n* Age 18-65 years.\n* BMI \\>=30 kg\u002Fm2 (i.e., obese).\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations at Screening and\u002For Check-in as assessed by one of the MD study personnel.\n* Able to speak and read English.\n* Apple or Android phone, or Android tablet with wi-fi or cellular service.\n* Vital signs at Screening and Check-in as per the following ranges and stable (measured in a supine position after a minimum of 5 minutes of rest):\n\n  * Systolic blood pressure ≥ 90 and ≤ 140 mmHg\n  * Diastolic blood pressure ≥ 50 and ≤ 90 mmHg\n  * Pulse rate ≥ 50 and ≤ 100 bpm\n\nExclusion Criteria\n\n* UK Students cannot participant\n* Current cannabis use (e.g., past month; negative test for cannabinoids during screening) and no more than 15 self-reported lifetime uses.\n* Self-reported current use of CBD.\n* Severe past negative experience with cannabis or cannabinoid use (e.g., panic attack, anxiety).\n* Use of any anti-obesity medication in the past 90 days. Specifically GLP-1 agonists (e.g., liraglutide, semaglutide, tirzepatide), SGLT-2 inhibitors (e.g., canagliflozin, dapagliflozin, empagliflozin, ertugliflozin), sulfonylureas (e.g., glimepiride, glipizide), medlitinides (e.g., repaglinide, nateglinide), Contrave, phentermine (alone or combination product such as Qsymia) or Orlistat. Stable use of metformin is permitted.\n* Current treatment with insulin.\n* History of type 1 diabetes.\n* Stable body weight over the past 3 months. No changes greater than 5 kg.\n* History of stomach or intestinal surgery or resection for obesity or otherwise (such as gastric bypass, sleeve-gastrectomy, bowel or small bowel resection) that would potentially alter absorption and\u002For excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair \\> 6 months prior to Screening will be allowed).\n* Obesity secondary to a known genetic, endocrine, or medical condition, such as polycystic ovarian syndrome, hypothyroidism, Cushing's syndrome, growth hormone deficiency, insulinoma, hypothalamic disorders (e.g., Froelich syndrome, Bardet-Biedl syndrome, Prader-Willi syndrome)\n* Moderate or Severe Substance Use Disorder according to DSM-5 criteria; urine test positive for recent use of an abused drug.\n* History of significant psychiatric disorder (e.g., bipolar, schizophrenia, depression, history of panic attacks).\n* Current use of psychiatric medications (e.g., antipsychotics, antidepressants, anxiolytics).\n* Current use of medications associated with hemodynamic instability (e.g., amphetamines, other sympathomimetic agents, atropine, scopolamine, other anticholinergic agents).\n* Current use of medications that are inhibitors of CYP2C9 (e.g., amiodarone, fluconazole) or CYP3A4 enzymes (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir, erythromycin, grapefruit juice).\n* A score of 15 or more on the Patient Health Questionnaire (PHQ-9).\n* Current or past year history of one or more of the following disorders associated with overeating: rumination disorder, bulimia nervosa, severe\u002Fextreme binge eating disorder (\\>7 episodes per week) or other specified\u002Funspecified feeding\u002Feating disorder that would increase risk to the participant or complicate interpretation of the data. Individuals who report mild to moderate (\\\u003C7 episodes per week) binge eating disorder are eligible.\n* Female participant who is pregnant, breast-feeding, or intends to become pregnant, or is of child-bearing potential and not using a highly effective contraceptive method.\n* Male participant who is not using a highly effective contraceptive method or who has a female partner who is not using a highly effective contraceptive method.\n* Any clinically important uncontrolled illness, medical\u002Fsurgical procedure, or major trauma within 8 weeks prior to dose administration on Day 1.\n* History of congestive heart failure or arrhythmias.\n* Any of the following cardiovascular events in the past 3 months\n\n  * acute myocardial infarction\n  * cerebrovascular accident (stroke)\n  * unstable angina\n* Lab-Screening Exclusion:\n\n  * Thyroid-stimulating hormone (TSH) level outside of the normal range, confirmed on repeat testing\n  * AST, ALT, or alkaline phosphatase \\>2x ULN\n  * EGFR \\\u003C60 ml\u002Fmin as calculated using the Cockroft-Gault equation.\n* History of significant hypersensitivity, intolerance, or allergy to a cannabinoid or \"gummy\" product.\n* Current use of any medications or supplement which would either compromise the validity of the study or the safety of the participant.\n* History of seizure or predisposing factors for seizure (head trauma resulting in unconsciousness in past six months or CNS tumors).\n* Meeting the following criteria from the Columbia Suicide Severity Rating Scale (C-SSRS):\n\n  * \"yes\" to Question 4 (Active Suicidal Ideation with Some Intent to Act, Without Specific Plan) or\n  * \"yes\" to Question 5 (Active Suicidal Ideation with Specific Plan and Intent) or\n  * \"yes\" to any of the suicide-related behaviors (actual attempt, interrupted attempt, aborted attempt, preparatory act, or behavior) and\n  * the ideation or behavior occurred within the past month.\n* Any disorder, unwillingness, or inability, not covered by any of the other exclusion criteria, which in an investigator's opinion, might jeopardize the participant's safety or compliance with the protocol.",true,"ALL","18 Years","65 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this study is to determine the initial efficacy of once daily oral cannabis for weight loss in obese individuals.",[28],"Obesity","NOT_YET_RECRUITING","2026-06-23",{"date":32,"type":33},"2026-06-25","ACTUAL",{"date":35,"type":22},"2026-07-31",{"date":37,"type":22},"2028-03-31",{"name":39,"class":40},"Joshua A. Lile, Ph.D.","OTHER",{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":4,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":23,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100638136","phase-1-the-impact-of-cobenfy-maintenance-on-cocaines-effects-100638136","NCT07624227","The Impact of Cobenfy Maintenance on Cocaine's Effects","Inclusion Criteria:\n\n* Must meet criteria for cocaine use disorder - report past month smoked or IV cocaine use, and provide a urine sample positive for recent cocaine use during screening.\n* Female subjects of childbearing potential must be using an effective form of birth control (e.g., birth control pills, surgical sterilization, IUD, cervical cap with a spermicide, or abstinence). Exceptions include women reporting 12 months of spontaneous amenorrhea, 6 months of spontaneous amenorrhea with a follicle stimulating hormone (FSH) level \\> 40 mIU\u002FmL, or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy. Urine pregnancy tests will be conducted prior to sessions to ensure that female subjects do not participate if pregnant.\n* Able to speak and read English.\n\nExclusion Criteria:\n\n* Chemistry values or screening outcomes including outside normal ranges that are deemed by the study physician to be clinically significant. Lipid levels are also included in this protocol as an additional check for cardiovascular health.\n* Persistent hypertension \\>140\u002F90 mmHg or tachycardia \\>100 bpm for three consecutive recordings during screening.\n* AST, ALT or alkaline phosphatase \\>3x ULN.\n* Creatinine levels \\>1.2x ULN will be repeated; subjects with creatinine re-test values remaining above this level will be excluded.\n* Bilirubin levels \\>1.5x ULN will be repeated to determine trends; subjects with bilirubin increasing over time will be excluded.\n* Subjects presenting with anemia (hematocrit \\\u003C 36) or evidence of current infection (white blood cell count \\> 5) are referred to their PCP. If urine protein is greater than trace, urinalysis is repeated, and subjects with continued elevation is referred to their PCP. Subjects can be reconsidered for enrollment if these issues are resolved.\n* Electrocardiogram abnormalities, including:\n* Atrial premature beats (\\>= 2 consecutive)\n* Ventricular premature beats (Lown's Grade 3 or higher; \\>= 2 consecutive beats, multiform)\n* Heart block (2nd or 3rd degree AV block or bundle branch block)\n* Pre-excitation syndromes (Wolff-Parkinson-White or Lown-Ganong-Levine)\n* QTc interval \\> 450 msec\n* History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of head trauma with prolonged loss of consciousness, seizures or CNS tumors, or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation.\n* First degree family member with significant premature cardiac comorbidity.\n* Contraindications for Cobenfy not covered by other exclusion criteria including urinary retention, moderate\u002Fsevere hepatic impairment, gastric retention and untreated narrow-angle glaucoma.\n* Meet diagnostic criteria for psychoactive substance use disorder for substances other than cocaine or nicotine\u002Fcaffeine that would require detoxification (i.e., alcohol, opioids, benzodiazepines or barbiturates). Negative urine\u002Fbreath samples for these substances, and the absence of withdrawal, will be required during screening.\n* Regular use of other medications, with the exception of hormone-based contraceptives for female subjects, daily multivitamins, short-term antibiotic prescriptions, and\u002For antiretrovirals for the hepatitis C virus.\n* Vision or hearing problems that would preclude completion of experimental tasks.\n* Poor venous access.\n* Seeking treatment for SUD.","60 Years",{"count":49,"type":22},32,[51,25],"PHASE1","The goal of this clinical trial is to learn if Cobenfy influences the effects of cocaine in people with cocaine use disorder. This trial will also provide information about the safety and tolerability of combining Cobenfy and cocaine.\n\nResearchers will compare Cobenfy to a placebo (a look-alike substance that contains no drug) to see if Cobenfy is a safe, tolerable and effective at blocking cocaine's effects in participants with cocaine use disorder.\n\nParticipants will:\n\n* Participate in an 11-day inpatient trial\n* Take Cobenfy or placebo twice per day.\n* Participate in experimental sessions to test the effects of Cobenfy (or placebo) on the response to cocaine and cocaine self-administration.",[54],"Cocaine Use Disorder (CUD)","2026-05-28",{"date":57,"type":33},"2026-06-03",{"date":59,"type":22},"2026-08-01",{"date":61,"type":22},"2032-06-30",{"name":39,"class":40},1,""]