[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT04218409":3,"trial-entities:NCT04218409":102,"trial-summary:NCT04218409":105},{"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":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":55,"secondary_outcomes":60,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":79,"locations":81,"central_contacts":90,"overall_officials":96,"references":100,"see_also_links":101},"NCT04218409","IRB201902618-N","Opioid-Sparing and Pain-Reducing Properties of Syntocinon: A Dose-Effect Determination","RECRUITING","2026-12-31","2026-01","2026-01-14","2021-09-02","University of Florida","OTHER",true,"Some research suggests that administration of oxytocin with oxycodone may reduce its abuse liability and improve its ability to reduce pain. In a 6-session laboratory study, the investigators will be evaluating the effects of oxycodone and oxytocin (combined and separately, across sessions) on experimentally-induced pain, subjective effects, decision-making, and activation of different neural substrates.","The overall project goals are to determine oxytocin effects on oxycodone's subject-rated abuse liability, experimental pain, and to describe the neurobehavioral mechanisms underlying interindividual differences in these effects. Generally healthy individuals (determined via medical history review and a screening session) will, after informed consent, self-administer intranasal oxytocin (or placebo, containing the same ingredients but no oxytocin) shortly after oral oxycodone or placebo in a non-residential, double-blind, randomized, placebo-controlled, within-subjects laboratory study. Prescreening will assure MRI eligibility and drug application safety and, using a validated, comprehensive pain history interview, determine previous or existing chronic pain conditions, including current pain medication use.",[18],"Pain",[],"INTERVENTIONAL","BASIC_SCIENCE",[23],"EARLY_PHASE1",{"count":25,"type":26},45,"ESTIMATED",[28,35,41,46,51],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","OxyCODONE 5 mg Oral Tablet","Oral oxycodone 5 mg orally",[33,34],"Oral oxycodone (5mg) + intranasal placebo","oxycodone (5mg) + intranasal oxytocin (48 IU)",{"type":29,"name":36,"description":37,"armGroupLabels":38},"Oxytocin nasal spray","Intranasal oxytocin administration (48 IU)",[39,34,40],"Oral oxycodone (2.5mg) + intranasal oxytocin (48 IU)","oxytocin+placebo",{"type":13,"name":42,"description":43,"armGroupLabels":44},"Placebo Oxycodone","Oxycodone 0 mg orally",[40,45],"placebo+placebo",{"type":13,"name":47,"description":48,"armGroupLabels":49},"Placebo oxytocin","Intranasal placebo administration",[50,33,45],"Oral oxycodone (2.5mg) + intranasal placebo",{"type":29,"name":52,"description":53,"armGroupLabels":54},"OxyCODONE 2.5 mg Oral Tablet","Oral oxycodone 2.5 mg orally",[39,50],[56],{"measure":57,"description":58,"timeFrame":59},"Subject-rated abuse liability","Using a Visual Analog Scale with scoring as 0=not at all, 20=possibly mild, 40=definitely mild, 60=moderately, 80=strongly, and 100=extremely, or any number in between. Testing occurs only in the context of 4 sessions due to a minimum of a one week washout period in between each session.","up to 6 weeks.",[],"ALL","21 Years","45 Years",{"inclusion":65,"exclusion":72,"raw_text":78},[66,67,68,69,70,71],"Individuals fluent in English will participate.","Must report recreational use of opioids.","Be within 20% of their ideal body weight.","Are not currently experiencing chronic pain (pain on most days during the past 3 months)","Have a systolic blood pressure of \\\u003C=140 and diastolic blood pressure of \\\u003C= 90, and a heart rate \\\u003C= 90 beats per minute.","Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.",[73,74,75,76,77],"Significant current physical disease or major psychiatric disorder.","No self-reported current interest in drug abuse treatment.","Women who are pregnant or nursing.","Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.","Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.","Inclusion Criteria:\n\n* Individuals fluent in English will participate.\n* Must report recreational use of opioids.\n* Be within 20% of their ideal body weight.\n* Are not currently experiencing chronic pain (pain on most days during the past 3 months)\n* Have a systolic blood pressure of \\\u003C=140 and diastolic blood pressure of \\\u003C= 90, and a heart rate \\\u003C= 90 beats per minute.\n* Participants must also have a normal electrocardiogram (EKG) reading and bloodwork indicating no major health contraindications.\n\nExclusion criteria:\n\n* Significant current physical disease or major psychiatric disorder.\n* No self-reported current interest in drug abuse treatment.\n* Women who are pregnant or nursing.\n* Any comorbid illicit substance use disorders or current clinically significant withdrawal for any abused drug excluding nicotine and caffeine.\n* Any conditions that preclude safety in the MRI scanner, such as: implanted electrical devices (e.g., cardiac pacemaker, neurostimulator); implanted metallic clips or pins (e.g., aneurysm clip); a history of working with metal (unless able to demonstrate participant is MRI safe), and claustrophobia.",[80],"ADULT",[82],{"facility":12,"status":7,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Gainesville","Florida","32611","United States",{"lat":88,"lon":89},29.65163,-82.32483,[91],{"name":92,"role":93,"phone":94,"email":95},"Lauren Nieder","CONTACT","352-294-1067","lauren.nieder@ufl.edu",[97],{"name":98,"affiliation":12,"role":99},"Meredith Berry, PhD","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":103,"biomarkers":104},[18],[],{"nct_id":4,"found":14,"summary":106,"prompt_version":116},{"design":107,"status":108,"heading":109,"summary":110,"follow_up":111,"word_count":112,"commitments":113,"compensation":114,"drugs_mentioned":115},"This is a double-blind, randomized, placebo-controlled study where participants will receive different treatments across multiple sessions. It involves 45 participants and is designed to compare the effects of oxytocin and oxycodone, both alone and in combination.","completed","Oxytocin and Oxycodone for Pain and Abuse Liability","This study is exploring if oxytocin nasal spray, when given with oxycodone (an opioid pain medication), can reduce oxycodone's potential for abuse and improve its pain-relieving effects. Researchers will give participants different combinations of oxycodone (5 mg or 2.5 mg oral tablets) and oxytocin nasal spray (48 IU), or placebos (inactive substances), to see how they affect pain and other responses. You might be eligible if you are between 21 and 45 years old, use opioids recreationally, are in good general health, and do not have chronic pain. The main goal is to understand how oxytocin affects the likelihood of oxycodone abuse. The study plans to enroll 45 participants, but its current status is unclear.","The primary endpoint, subject-rated abuse liability, will be measured at up to 6 weeks.",115,"You would participate in a 6-session laboratory study. This includes a medical history review, a screening session, and self-administering intranasal oxytocin or placebo shortly after oral oxycodone or placebo.","Not stated in the trial record.",[36],"v2"]