[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06757140":3,"trial-entities:NCT06757140":137,"trial-summary:NCT06757140":142},{"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":21,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":32,"interventions":35,"primary_outcomes":63,"secondary_outcomes":68,"sex":84,"minimum_age":85,"maximum_age":86,"healthy_volunteers":15,"eligibility_criteria":87,"std_ages":110,"locations":112,"central_contacts":130,"overall_officials":133,"references":135,"see_also_links":136},"NCT06757140","97946","Opioid Drug Interaction Study","Opioid Drug Interactions: Safety, Abuse Potential and Pharmacokinetic Effects","RECRUITING","2029-06-01","2026-05","2026-05-14","2025-04-01","Shanna Babalonis, PhD","OTHER",false,"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.","Alprazolam (Xanax®) is a short-acting benzodiazepine that is the commonly prescribed in the U.S. (\\>15 million prescriptions in 2021) and CDC reporting indicates that alprazolam was associated with the greatest increase in number of ED presentations of the benzodiazepines. This study will examine the effects of a widely prescribed and abused mu opioid agonist, oxycodone, and a widely prescribed and abused benzodiazepine, alprazolam, when given alone and in combination to experienced drug using volunteers. Key safety outcomes, including expired CO2, pharmacodynamic measures related to abuse potential, and cognitive\u002Fpsychomotor performance will be thoroughly examined over a range of doses for both drugs alone and in combination. Pharmacokinetic data will also be collected and analyzed to assess the potential pharmacokinetic interaction as an underlying mechanism of action.",[19,20],"Drug Interactions","Drug Kinetics",[22,23,24,25,26],"inpatient study","opioids","opiates","sedatives","opioid misuse","INTERVENTIONAL","BASIC_SCIENCE",[30,31],"PHASE1","PHASE2",{"count":33,"type":34},25,"ESTIMATED",[36,49,58],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":47},"DRUG","Alprazolam","Participants will receive varying non-therapeutic experimental doses of oral alprazolam, alone and in combination with oral oxycodone",[41,42,43,44,45,46],"Alprazolam high oral dose (Xanax) \u002F Oxycodone high oral dose (Percocet, Roxicodone)","Alprazolam high oral dose (Xanax) \u002F Oxycodone low oral dose (Percocet, Roxicodone)","Alprazolam high oral dose (Xanax) \u002F Placebo","Alprazolam low oral dose (Xanax) \u002F Oxycodone high oral dose (Percocet, Roxicodone)","Alprazolam low oral dose (Xanax) \u002F Oxycodone low oral dose (Percocet, Roxicodone)","Alprazolam low oral dose (Xanax) \u002F Placebo",[48],"Xanax",{"type":37,"name":50,"description":51,"armGroupLabels":52,"otherNames":55},"Oxycodone","Participants will receive varying non-therapeutic experimental doses of oral oxycodone, alone and in combination with oral alprazolam",[41,42,44,45,53,54],"Placebo \u002F Oxycodone high oral dose (Percocet, Roxicodone)","Placebo \u002F Oxycodone low oral dose (Percocet, Roxicodone)",[56,57],"Percocet","Roxicodone",{"type":37,"name":59,"description":60,"armGroupLabels":61},"Placebo","Participants will receive inactive oral doses",[43,46,53,54,62],"Placebo \u002F Placebo",[64],{"measure":65,"description":66,"timeFrame":67},"Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Liking","Participants rated their subjective drug liking on a standardized VAS scale (0 to 100) with higher scores equating to increased liking. Raw data transformed to peak scores.","This outcome was recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).",[69,72,76,80],{"measure":70,"description":71,"timeFrame":67},"Change in Subject-Rated Outcome: Visual Analog Scale (VAS) Drug Effect","Participants rated their subjective drug effect on a standardized VAS scale (0 to 100) with higher scores equating to increased effect. Raw data transformed to peak scores.",{"measure":73,"description":74,"timeFrame":75},"Change in Respiration Rate","Respiration rate monitored throughout each session. Raw data transformed to trough scores.","Respiration rate recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).",{"measure":77,"description":78,"timeFrame":79},"Change in End-tidal Carbon Dioxide (EtCO2)","Change in End-tidal Carbon Dioxide (EtCO2) monitored throughout each session. Raw data transformed to peak scores.","End-tidal Carbon Dioxide (EtCO2) recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).",{"measure":81,"description":82,"timeFrame":83},"Change in Oxygen Saturation","Oxygen Saturation monitored throughout each session. Raw data transformed to trough scores.","Oxygen Saturation recorded prior to and in regular intervals after drug administration for the duration of the session (approx. 6.5 hours per session).","ALL","18 Years","55 Years",{"inclusion":88,"exclusion":98,"raw_text":109},[89,90,91,92,93,94,95,96,97],"English-speaking and literate participants, able to understand and sign Informed Consent Document","ages 18 to 55 years old inclusive","BMI of greater than\u002Fequal to 17 and approximately less than or equal to 30","self-reported opioid use","self-reported sedative-like drug use","women of childbearing potential must not be pregnant or breastfeeding at screening and be using an effective form of contraception throughout study participation","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)","willing and able to comply with all testing requirements defined in the protocol","adequate venous access (determined by RN) for pharmacokinetic blood draws",[99,100,101,102,103,104,105,106,107,108],"physical dependence on alcohol, opioids, benzodiazepines or sedative\u002Fhypnotics requiring medical management\u002Fdetoxification","seeking treatment for opioid or any other drug use","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\\])","clinically significant abnormal ECG (as determined by study physician\u002Fcardiologist)","clinically significant abnormal laboratory findings (e.g., liver function tests greater than 3x the upper limits of normal range)","current or past history of major psychiatric disorder that would limit ability to participate in the study (e.g., bipolar disorder).","recent use of CYP2C9, CYP2D6 and CYP3A4 inhibitor or inducer that is long-acting and not amenable to a wash-out period after enrollment","known hypersensitivity to any of the study drugs","currently pregnant or breastfeeding","currently under parole or probation with urine testing requirements","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",[111],"ADULT",[113],{"facility":114,"status":8,"city":115,"state":116,"zip":117,"country":118,"contacts":119,"geoPoint":127},"University of Kentucky","Lexington","Kentucky","40508","United States",[120,125],{"name":121,"role":122,"phone":123,"email":124},"Paul A Nuzzo","CONTACT","859-323-0002","paul.nuzzo@uky.edu",{"name":13,"role":126},"PRINCIPAL_INVESTIGATOR",{"lat":128,"lon":129},37.98869,-84.47772,[131],{"name":121,"role":122,"phone":132,"email":124},"(859) 323-0002",[134],{"name":13,"affiliation":114,"role":126},[],[],{"nct_id":4,"conditions":138,"biomarkers":141},[139,140],"Opioid Use Disorder","Sedative Use",[],{"nct_id":4,"found":143,"summary":144,"prompt_version":154},true,{"design":145,"status":146,"heading":147,"summary":148,"follow_up":149,"word_count":150,"commitments":151,"compensation":152,"drugs_mentioned":153},"This interventional study plans to enroll 25 participants. It will test different doses of alprazolam and oxycodone, alone and in combination, against a placebo.","completed","Opioid Drug Interaction Study with Alprazolam and Oxycodone","This study is looking at how two common medications, alprazolam (Xanax®) and oxycodone, affect people when taken alone and together. Researchers will give you non-therapeutic (not for treatment) doses of alprazolam, oxycodone, or a placebo (an inactive pill). They want to understand how these drugs interact and what effects they have on your body and how you feel. The main goal is to see how much you \"like\" the drug, measured by a special rating scale. You might be able to join if you are 18 to 55 years old, speak English, have a certain body mass index (BMI), and have reported using opioids and sedative-like drugs in the past. The current recruitment status is unclear.","Not specified.",116,"Participants will receive different oral doses of alprazolam, oxycodone, or placebo. Your subjective ratings of drug liking and other effects will be measured for about 6.5 hours per session.","Not stated in the trial record.",[38,50,59],"v2"]