[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100320027":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":46,"centralContacts":51,"locations":60,"responsibleParty":80,"collaborators":45,"id":82,"slug":83,"hasResults":84,"nctId":85,"briefTitle":86,"officialTitle":87,"acronym":45,"eligibilityCriteria":88,"healthyVolunteers":84,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":45,"studyType":95,"phases":96,"briefSummary":99,"conditions":100,"keywords":102,"overallStatus":63,"whyStopped":45,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"University of Maryland, Baltimore","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Saline","PLACEBO_COMPARATOR","Under direction of a research team member, participants will self-administer intranasal normal saline shortly before beginning the fMRI experiment.\n\nInvestigators, staff, and participants were blinded to the treatment options. Each of the agents will be administrated by means of a nasal spray. Participants will be instructed by a nurse\u002FPI to self-administer the nasal spray as follows: one spray in each nostril alternating sides, 30 seconds apart for a total of two sprays per nostril.",[13,14,15],"Other: Saline","Behavioral: Observational learning","Other: fMRI data aquisition",{"label":17,"type":18,"description":19,"interventionNames":20},"Arginine vasopressin","EXPERIMENTAL","Under direction of a research team member, participants will self-administer intranasal vasopressin shortly before beginning the fMRI experiment. The of AVP will be 40IU. The quantity per unit (1 mL) of Arg8-vasopressin synthetic, manufactured by Polypeptide Group Inc. (http:\u002F\u002Fwww.polypeptide.com) was 0.323 mg. This amount was diluted in 0.9% sodium chloride (B. Broun Medical Inc.).",[21,14,15],"Drug: Arginine vasopressin",[23,29,34,41],{"type":24,"name":17,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Intranasal vasopressin will be administered shortly before the fMRI experiment.",[17],[28],"Arg8-vasopressin synthetic",{"type":6,"name":9,"description":30,"armGroupLabels":31,"otherNames":32},"Intranasal saline will serve as a placebo for participants in the Saline Arm",[9],[33],"Placebo",{"type":35,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"BEHAVIORAL","Observational learning","During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.",[17,9],[40],"Social observation",{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":45},"fMRI data aquisition","All participants from the intranasal vasopressin and intranasal saline groups will go through a fMRI data acquisition to obtain the brain structural, brain resting-states and functional MRI scans.",[17,9],null,[47],{"name":48,"affiliation":49,"role":50},"Luana Colloca, MD\u002FPHD\u002FMS","University of Maryland Baltimore School of Nursing","PRINCIPAL_INVESTIGATOR",[52,57],{"name":53,"role":54,"phone":55,"phoneExt":45,"email":56},"Research Coordinator","CONTACT","410-706-5975","nrscollocalab@umaryland.edu",{"name":58,"role":54,"phone":45,"phoneExt":45,"email":59},"Rachel Massalee, MS","rmassalee@umaryland.edu",[61],{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Luana Colloca","RECRUITING","Baltimore","Maryland","21201-1512","United States","US",{"type":70,"coordinates":71},"Point",[72,73],-76.61219,39.29038,{"lat":73,"lon":72},[76],{"name":77,"role":54,"phone":78,"phoneExt":45,"email":79},"Luana Colloca, MD, PhD, MS","301-364-8089","colloca@umaryland.edu",{"type":50,"investigatorFullName":62,"investigatorTitle":81,"investigatorAffiliation":5,"oldNameTitle":45,"oldOrganization":45},"Associate Professor","100320027","phase-1-vasopressin-and-pain-perception-in-the-brain-100320027",true,"NCT03446456","Vasopressin and Pain Perception in the Brain","The Influence of Vasopressin on Observational Learning of Placebo Analgesia","Inclusion Criteria:\n\n* Age ( 18-55 years old)\n* English speaker (written and spoken)\n\nExclusion Criteria:\n\n* Cardiovascular, neurological diseases, pulmonary abnormalities, kidney disease, liver disease, degenerative neuromuscular disease, history of cancer within past 3 years\n* Any history of chronic pain disorder or currently in pain\n* Severe psychiatric condition (e.g. schizophrenia, bipolar disorders, mania, autism) and \u002For psychiatric condition leading to treatment and\u002For hospitalization within the last 3 years.\n* Family (first degree) history of mania, schizophrenia, or other psychoses\n* Lifetime alcohol\u002Fdrug dependence or alcohol\u002Fdrug abuse in past 3 months\n* Pregnancy or breast feeding\n* Color-blindness\n* Impaired, uncorrected hearing\n* History of angioedema\n* High blood pressure (above 140 mmHg) or symptomatic low blood pressure\n* History of fainting\n* Left handed\n* Allergies or sensitivities to creams, lotions or food coloring\n* Any non-organic implant or any non-removable metal device (e.g. pacemaker, cochlear implants, stents, surgical clips, non-removable piercings)\n* Any prior eye injury or the potential of a foreign body in the eye (e.g. worked in metal fields)Persisting functional impairment due to a head trauma\n* Fear of closed spaces\n* Any other contraindications for MRI (e.g. large tattoos on head and neck)\n* Previously participated in a \"Pain Perception in the Brain\" Study\n* Failed drug test (testing for opiates, cocaine, methamphetamines, amphetamines and THC)","ALL","18 Years","65 Years",{"count":93,"type":94},56,"ESTIMATED","INTERVENTIONAL",[97,98],"PHASE1","PHASE2","The feeling of pain is not just a sensory experience, but is also influenced by emotions, beliefs and expectations, making pain a highly subjective experience. This is evident in clinical practice, where the behavior of the physician and the treatment context can strongly influence the pain experience of patients. Research has shown that patients' expectation that a treatment will reduce pain influences individual perception of pain, even if the treatment has no active ingredient. The expectancy-induced analgesia emerges due to a modulation of the individual pain experience of patients by an engagement of endogenous inhibitory systems in the central nervous system.\n\nThe development of expectancy-induced analgesia can be generated in several ways. The investigators have previously demonstrated that social information and observational learning (e.g. the patient observes analgesia in another person receiving a treatment) can lead to expectancy-induced analgesia and pain reduction. However, the neural mechanisms (mechanisms in the brain) of how these expectancies are acquired and the neural mechanisms of analgesia induced by observational learning are unknown.\n\nThe investigators recently established a procedure to investigate neural mechanisms of observational learning in placebo analgesia. Here the investigators propose to investigate the influence of vasopressin, a neurotransmitter that is important for social interaction, on observational learning.\n\nThe investigators will use functional magnetic resonance imaging (fMRI), a non-invasive method, to investigate neural activity in humans. Participants will either receive vasopressin or saline with a nasal spray. During fMRI scanning, participants will then undergo an observational learning phase, where the study participants will learn the experience of analgesia in another person through a video, and a testing phase, where participants will perceive painful stimulations with the same cues as the observational phase. The comparison of the vasopressin group and the saline group will allow us to investigate how vasopressin influences behavioral effects of observational learning on pain perception as well as its effect on the neural processing of observational learning.\n\nA better understanding of how the human brain processes observationally-induced analgesia would allow us to improve the therapeutic context of pain treatments by increasing the contextual factors which help patients cope with pain.",[101],"Acute Pain",[103,104,105,106,107,108],"Magnetic Resonance Imaging","Healthy Volunteers","Arginine Vasopressin","Antidiuretic Hormone","Analgesia","Social Behavior","2026-07-06",{"date":111,"type":112},"2026-07-09","ACTUAL",{"date":114,"type":112},"2018-09-17",{"date":116,"type":94},"2026-12-31",{"name":5,"class":6},1]