{
  "FullStudy":{
    "Rank":218041,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513499",
          "OrgStudyIdInfo":{
            "OrgStudyId":"MGH1004"
          },
          "Organization":{
            "OrgFullName":"Massachusetts General Hospital",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Men and Women",
          "OfficialTitle":"Effect of Intranasal Oxytocin on Appetite and Caloric Intake in Humans"
        },
        "StatusModule":{
          "StatusVerifiedDate":"April 2019",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"January 2014",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"January 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 11, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"April 4, 2019",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"April 8, 2019",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Elizabeth Austen Lawson",
            "ResponsiblePartyInvestigatorTitle":"Assistant in Medicine",
            "ResponsiblePartyInvestigatorAffiliation":"Massachusetts General Hospital"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Massachusetts General Hospital",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Exciting advances have led to the concept that hormones can modulate appetite and food intake. Oxytocin is a peptide hormone that is released in regions throughout the brain, including areas involved in food motivation. Animal studies suggest that oxytocin may reduce food intake. The effects of oxytocin administration on eating behavior in humans, which could have important implications in eating-related disorders ranging from obesity to anorexia nervosa, have not been investigated. This double-blind placebo-controlled cross-over study of single-dose oxytocin administration investigates whether:\n\nCaloric intake will decrease following administration of oxytocin versus placebo\nAppetite will decrease following administration of oxytocin versus placebo\nResting energy expenditure will increase following administration of oxytocin versus placebo"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Eating Behavior"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Eating behavior",
              "Appetite",
              "Oxytocin",
              "Neuropeptide"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Early Phase 1"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Crossover Assignment",
            "DesignPrimaryPurpose":"Other",
            "DesignMaskingInfo":{
              "DesignMasking":"Quadruple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Care Provider",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"25",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Oxytocin",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"Intranasal oxytocin",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Oxytocin"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Intranasal placebo",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Oxytocin",
                "InterventionDescription":"Intranasal oxytocin 24 IU single-dose administration",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Oxytocin"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Syntocinon (Novartis)"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo",
                "InterventionDescription":"Intranasal Placebo single-dose administration",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Caloric intake",
                "PrimaryOutcomeTimeFrame":"+60 minutes after drug/placebo"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Appetite",
                "SecondaryOutcomeDescription":"Assessed using a Visual Analogue Scale",
                "SecondaryOutcomeTimeFrame":"+55 (fasting) and +90 minutes (post-prandial) after drug/placebo"
              },{
                "SecondaryOutcomeMeasure":"Resting energy expenditure",
                "SecondaryOutcomeDescription":"Assessed using metabolic cart",
                "SecondaryOutcomeTimeFrame":"+30 minutes after drug/placebo"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n18-45 years old\nBMI 18.5-24.9, 25-40\nRegular breakfast eater (at least 4 times per week)\nStable weight within the past three months\n\nExclusion Criteria:\n\nPsychiatric disease\nUse of psychotropic medications\nHistory of eating disorder\nHistory of excessive exercise within the last three months\nHistory of diabetes mellitus\nActive substance abuse\nHematocrit below normal range\nGastrointestinal tract surgery (including gastrectomy, gastric bypass surgery, and small or large bowel resection)\nHistory of cardiovascular disease (such as hypertrophic cardiomyopathy, valvular heart disease, coronary heart disease, or coronary artery spasms)\nUntreated thyroid disease\nTobacco use",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"45 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Elizabeth A Lawson, MD",
                "OverallOfficialAffiliation":"Massachusetts General Hospital",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Massachusetts General Hospital",
                "LocationCity":"Boston",
                "LocationState":"Massachusetts",
                "LocationZip":"02114",
                "LocationCountry":"United States"
              }
            ]
          }
        },
        "IPDSharingStatementModule":{
          "IPDSharing":"Undecided"
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000010121",
                "InterventionMeshTerm":"Oxytocin"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000010120",
                "InterventionAncestorTerm":"Oxytocics"
              },{
                "InterventionAncestorId":"D000012102",
                "InterventionAncestorTerm":"Reproductive Control Agents"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M11624",
                "InterventionBrowseLeafName":"Oxytocin",
                "InterventionBrowseLeafAsFound":"Oxytocin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M247153",
                "InterventionBrowseLeafName":"Lactitol",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Repr",
                "InterventionBrowseBranchName":"Reproductive Control Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              }
            ]
          }
        }
      }
    }
  }
}