[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05829655":3,"trial-entities:NCT05829655":112,"trial-summary:NCT05829655":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":51,"secondary_outcomes":63,"sex":68,"minimum_age":69,"maximum_age":70,"healthy_volunteers":71,"eligibility_criteria":72,"std_ages":85,"locations":88,"central_contacts":106,"overall_officials":108,"references":110,"see_also_links":111},"NCT05829655","HP-00116510","Measuring Acute Drug Demand in Humans","RECRUITING","2028-01-01","2026-06","2026-06-23","2023-08-08","University of Maryland, Baltimore","OTHER",false,"This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs.","This research is being done to evaluate whether suvorexant may reduce the use of, subjective liking, and demand for various drugs. Suvorexant is not approved as a treatment to reduce drug use but is approved by the Food and Drug Administration (FDA) to treat insomnia (trouble falling asleep or staying asleep). This study consists of a screening visit and an approximate 14 to 16 day inpatient (overnight) stay at the University of Maryland, Baltimore. Participants will be stabilized on hydromorphone, randomly assigned to receive either suvorexant or placebo, and complete 5 experimental sessions that include taking blinded study medications.",[18,19],"Opioid Use Disorder","Opioid Dependence",[],"INTERVENTIONAL","BASIC_SCIENCE",[24],"EARLY_PHASE1",{"count":26,"type":27},75,"ESTIMATED",[29,36,39,42,45,48],{"type":30,"name":31,"description":32,"armGroupLabels":33},"DRUG","Drug A (Blinded Drug)","Participants will receive a double-blinded oral study medication as part of their daily sessions and will provide feedback regarding the effects of the medication on various measures. Though the study medications are FDA approved, they are being used here for a non-FDA approved purpose (though the FDA has provided permission to use these drugs in this study).",[34,35],"Placebo","Suvorexant (20mg\u002Fday)",{"type":30,"name":37,"description":32,"armGroupLabels":38},"Drug B (Blinded Drug)",[34,35],{"type":30,"name":40,"description":32,"armGroupLabels":41},"Drug C (Blinded Drug)",[34,35],{"type":30,"name":43,"description":32,"armGroupLabels":44},"Drug D (Blinded Drug)",[34,35],{"type":30,"name":35,"description":46,"armGroupLabels":47},"Double blind administration of suvorexant once per day during residential stay until discharge.",[35],{"type":30,"name":34,"description":49,"armGroupLabels":50},"Double blind administration of placebo once per day during residential stay until discharge.",[34],[52,56,59],{"measure":53,"description":54,"timeFrame":55},"Demand Intensity","Consumption of blinded drug at unconstrained price as measured by an incentivized demand task. Minimum value is 0, maximum value is not constrained. Higher scores indicate more drug consumption at unconstrained price (a worse outcome).","Upon completion of experimental session (~8 hours post drug administration)",{"measure":57,"description":58,"timeFrame":55},"Demand Elasticity","Changes in blinded drug consumption with changes in price as measured by an incentivized demand task. There is no minimum or maximum value. Higher scores indicate greater drug price sensitivity (a better outcome).",{"measure":60,"description":61,"timeFrame":62},"Cross-Price Elasticity","Change in consumption of price-fixed good based on change in price of price varying good. Positive values indicate a substitute, negative values indicate a complement, and zero values indicate an independent commodity.","After Experimental Session 4",[64],{"measure":65,"description":66,"timeFrame":67},"Total Mean Sleep Time","Mean total number of minutes slept per night as measured by actigraphy and self-reported sleep diary. Mean total sleep time will be collected daily.","Through study completion, up to two weeks","ALL","18 Years","65 Years",true,{"inclusion":73,"exclusion":79,"raw_text":84},[74,75,76,77,78],"Age between 18 and 65 years old","Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)","Lifetime substance use history criterion \\[blinded\\]","Medically cleared to take suvorexant and blinded study medications","Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests",[80,81,82,83],"Pregnant or breast feeding","Seeking opioid use treatment","Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff","Known contraindications or allergies to suvorexant and\u002For the blinded study medications","Inclusion Criteria:\n\n* Age between 18 and 65 years old\n* Meets Diagnostic and Statistical Manual-5 criteria for Opioid Use Disorder (OUD) (moderate or severe)\n* Lifetime substance use history criterion \\[blinded\\]\n* Medically cleared to take suvorexant and blinded study medications\n* Be in good general health based on a physical examination, medical history, vital signs, and screening urine and blood tests\n\nExclusion Criteria:\n\n* Pregnant or breast feeding\n* Seeking opioid use treatment\n* Significant mental health or physical disorder that is expected to interfere with study participation as assessed by the study physicians or medical staff\n* Known contraindications or allergies to suvorexant and\u002For the blinded study medications",[86,87],"ADULT","OLDER_ADULT",[89],{"facility":90,"status":7,"city":91,"state":92,"zip":93,"country":94,"contacts":95,"geoPoint":103},"General Clinical Research Center","Baltimore","Maryland","21201","United States",[96,101],{"name":97,"role":98,"phone":99,"email":100},"Justin Strickland, PhD","CONTACT","667-354-3516","jstrickland@som.umaryland.edu",{"name":97,"role":102},"PRINCIPAL_INVESTIGATOR",{"lat":104,"lon":105},39.29038,-76.61219,[107],{"name":97,"role":98,"phone":99,"email":100},[109],{"name":97,"affiliation":12,"role":102},[],[],{"nct_id":4,"conditions":113,"biomarkers":114},[19,18],[],{"nct_id":4,"found":71,"summary":116,"prompt_version":126},{"design":117,"status":118,"heading":119,"summary":120,"follow_up":121,"word_count":122,"commitments":123,"compensation":124,"drugs_mentioned":125},"This is an interventional study with an unclear status, planning to enroll 75 participants. It involves a double-blinded approach, meaning neither you nor the researchers will know if you are receiving suvorexant or a placebo, or which blinded study medication you are taking.","completed","Measuring Acute Drug Demand in Opioid Use Disorder","This study is looking at how suvorexant, an FDA-approved medication for insomnia, might affect the desire for and use of other drugs in people with Opioid Use Disorder (OUD). You would stay overnight at the University of Maryland, Baltimore for about 14-16 days. During this time, you would receive suvorexant or a placebo (an inactive substance) and also take different blinded study medications (Drug A, Drug B, Drug C, Drug D). Researchers will measure how much you want these drugs and how much you might use them. The study aims to enroll 75 participants aged 18-65 who meet criteria for moderate or severe OUD and are in good general health.","Primary outcomes are measured upon completion of experimental sessions, which occur approximately 8 hours after drug administration, and after Experimental Session 4.",110,"You would have a screening visit, followed by an approximate 14 to 16-day inpatient (overnight) stay. During this stay, you will receive daily oral study medications and provide feedback.","Not stated in the trial record.",[],"v2"]