[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-kinetics\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-kinetics":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":5},"100574273","phase-1-opioid-drug-interaction-study-100574273",false,"NCT06757140","Opioid Drug Interaction Study","Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects","Inclusion Criteria:\n\n* English-speaking and literate participants, able to understand and sign Informed Consent Document\n* ages 18 to 55 years old inclusive\n* BMI of greater than\u002Fequal to 17 and approximately less than or equal to 30\n* self-reported opioid use\n* self-reported sedative-like drug use\n* women of childbearing potential must not be pregnant or breastfeeding at screening and be using an effective form of contraception throughout study participation\n* otherwise healthy as determined by the medical\u002Fresearch team based on medical history, physical examination, vital signs, laboratory chemistries (blood chemistry with liver function tests and hematology, urinalysis and microscopic evaluation, 12-lead electrocardiogram)\n* willing and able to comply with all testing requirements defined in the protocol\n* adequate venous access (determined by RN) for pharmacokinetic blood draws\n\nExclusion Criteria:\n\n* physical dependence on alcohol, opioids, benzodiazepines or sedative\u002Fhypnotics requiring medical management\u002Fdetoxification\n* seeking treatment for opioid or any other drug use\n* acute medical problem (e.g., infection) or chronic medical problem requiring daily medication or ongoing medical care (e.g., hypertension, cardiovascular disease, diabetes, respiratory disorders \\[e.g., asthma, COPD\\])\n* clinically significant abnormal ECG (as determined by study physician\u002Fcardiologist)\n* clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range)\n* current or past history of major psychiatric disorder that would limit ability to participate in the study (e.g., bipolar disorder).\n* recent use of CYP2C9, CYP2D6 and CYP3A4 inhibitor or inducer that is long-acting and not amenable to a wash-out period after enrollment\n* known hypersensitivity to any of the study drugs\n* currently pregnant or breastfeeding\n* currently under parole or probation with urine testing requirements","ALL","18 Years","55 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study will examine the effects of doses of opioid\u002Fplacebo and doses of alprazolam\u002Fplacebo, alone and in combination. The primary outcomes are pharmacodynamic measures (subjective ratings of drug liking and other abuse-related effects; physiological outcomes) and pharmacokinetic outcomes (from blood samples) to determine the interaction effects of these compounds.",[28,29],"Drug Interactions","Drug Kinetics",[31,32,33,34,35],"inpatient study","opioids","opiates","sedatives","opioid misuse","RECRUITING","2026-05-13",{"date":39,"type":40},"2026-05-14","ACTUAL",{"date":42,"type":40},"2025-04-01",{"date":44,"type":21},"2029-06-01",{"name":46,"class":47},"Shanna Babalonis, PhD","OTHER"]