{
  "FullStudy":{
    "Rank":217858,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515917",
          "OrgStudyIdInfo":{
            "OrgStudyId":"IRB_53174"
          },
          "Organization":{
            "OrgFullName":"University of Utah",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Citicoline and Omega-3 Fatty Acid Effects in Veterans With Traumatic Brain Injury (TBI)",
          "OfficialTitle":"Citicoline and Omega-3 Fatty Acid Effects in Veterans With TBI"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2015",
          "OverallStatus":"Withdrawn",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2013"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"July 2016",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2017",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 15, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 19, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor-Investigator",
            "ResponsiblePartyInvestigatorFullName":"Deborah Yurgelun-Todd",
            "ResponsiblePartyInvestigatorTitle":"Professor of Psychiatry",
            "ResponsiblePartyInvestigatorAffiliation":"University of Utah"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Deborah Yurgelun-Todd",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This is a placebo-controlled study intended to examine the effects of the neutraceutical citicholine, together with omega-3 fatty acids, on a range of measures in individuals with concussive head injury, often referred to as traumatic brain injury, or TBI. The study will consist of three visits, during which participants will complete brain scans, a thorough testing battery and a clinical interview to assess mood and other diagnostic information relevant to the study."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Traumatic Brain Injury",
              "Substance Abuse",
              "Substance Dependence"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Veterans",
              "Traumatic Brain Injury",
              "TBI",
              "Substance Abuse",
              "Substance Dependence",
              "Veterans with traumatic brain injury (TBI)",
              "Veterans with substance abuse or dependence"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Triple",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"0",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Citicoline and Omega-3",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"At visit 1 and again at visit 2, participants assigned to the experimental arm will receive a 14-day supply of citicoline and omega-3 fatty acid, of which they will be instructed to take 1000 mg and 2000 mg daily, respectively. This will be done in a double-blind, randomized fashion.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Citicoline",
                    "Drug: Omega-3"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"At visit 1 and again at visit 2, participants assigned to the placebo group will be given 14-day supplies of placebo to be taken daily throughout the study period. This will be done in a double-blind, randomized fashion.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Other: Rice bran oil",
                    "Other: Microcrystalline Cellulose"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Citicoline",
                "InterventionDescription":"Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 1000 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Citicoline and Omega-3"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Cognizin Citicoline"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Omega-3",
                "InterventionDescription":"Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 2000 mg daily omega-3. These participants will receive a 14-day supply of omega-3 at visit 1 and again at visit 2, making for a 28-day administration period.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Citicoline and Omega-3"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Omegabrite"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Rice bran oil",
                "InterventionDescription":"Rice bran oil will be one of two placebos administered to participants randomly assigned to the placebo arm. Rice bran oil will serve as the placebo for omega-3 fatty acids and will be orally administered daily in 500 mg doses.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              },{
                "InterventionType":"Other",
                "InterventionName":"Microcrystalline Cellulose",
                "InterventionDescription":"Microcrystalline Cellulose will be one of two placebos administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Neurocognitive performance",
                "PrimaryOutcomeDescription":"Using baseline assessment measures gathered at Visit 1, assessments collected at Visits 2 and 3 will be used to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids will improve neurocognitive performance in individuals with TBI and substance abuse/dependence.",
                "PrimaryOutcomeTimeFrame":"28 days"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Brain changes",
                "SecondaryOutcomeDescription":"Participants will undergo MRI scanning designed to assess white matter microstructure and focal brain activation at Visit 1 (Day 0) and again at Visit 3 (Day 28) in order to determine whether the combined administration of neutraceuticals citicoline and omega-3 fatty acids result in changes to these brain indices in participants with TBI and substance abuse/dependence.",
                "SecondaryOutcomeTimeFrame":"28 days"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nVeteran status\nAge 18 to 55\nHistory of TBI\nDSM-IV-TR diagnosis of abuse or dependence disorder for either alcohol or drugs of abuse\nMultiple concussive head injuries that meet the following criteria for TBI: 1) normal structural imaging, 2) loss of consciousness (LOC) between 0-30 minutes, 3) alteration of consciousness or mental status for a moment up to 2 hours or 4) post-traumatic amnesia of 0-1 day\nStable on current psychotropic medication regimen for ≥ 3 months\n\nExclusion Criteria:\n\nNon Veteran\nSignificant medical or neurological illness with the exception of TBI, which might affect cognitive function\nSignificant medical illness which has the potential to be exacerbated by ingestion of citicoline/omega-3 fatty acids, including diabetes, congestive heart disorder, hyperlipidemia and severe coronary artery disease\nAge other than 18 to 55 years old\nHistory of ECT treatment\nEstimated IQ < 70\nPast or present history of bipolar disorder, schizophrenia, delusional disorder or any other psychotic disorder\nCurrently taking a prescribed blood thinner (i.e., Coumadin)\nClaustrophobia\nMetal implanted within the body\nPregnancy or lactation\nLeft-handedness\nPoor vision, as subjects must have normal or corrected-to-normal vision for viewing of cognitive challenge paradigms during fMRI protocols\nNon-native English speakers (for neurocognitive tasks)",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000003566",
                "InterventionMeshTerm":"Cytidine Diphosphate Choline"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000018697",
                "InterventionAncestorTerm":"Nootropic Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M5354",
                "InterventionBrowseLeafName":"Cytidine Diphosphate Choline",
                "InterventionBrowseLeafAsFound":"Citicoline",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M4617",
                "InterventionBrowseLeafName":"Choline",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T415",
                "InterventionBrowseLeafName":"Omega 3 Fatty Acid",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"T443",
                "InterventionBrowseLeafName":"Choline",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"NootAg",
                "InterventionBrowseBranchName":"Nootropic Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              },{
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Lipd",
                "InterventionBrowseBranchName":"Lipid Regulating Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Ot",
                "InterventionBrowseBranchName":"Other Dietary Supplements"
              },{
                "InterventionBrowseBranchAbbrev":"Vi",
                "InterventionBrowseBranchName":"Vitamins"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001930",
                "ConditionMeshTerm":"Brain Injuries"
              },{
                "ConditionMeshId":"D000070642",
                "ConditionMeshTerm":"Brain Injuries, Traumatic"
              },{
                "ConditionMeshId":"D000019966",
                "ConditionMeshTerm":"Substance-Related Disorders"
              },{
                "ConditionMeshId":"D000014947",
                "ConditionMeshTerm":"Wounds and Injuries"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000001927",
                "ConditionAncestorTerm":"Brain Diseases"
              },{
                "ConditionAncestorId":"D000002493",
                "ConditionAncestorTerm":"Central Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000009422",
                "ConditionAncestorTerm":"Nervous System Diseases"
              },{
                "ConditionAncestorId":"D000006259",
                "ConditionAncestorTerm":"Craniocerebral Trauma"
              },{
                "ConditionAncestorId":"D000020196",
                "ConditionAncestorTerm":"Trauma, Nervous System"
              },{
                "ConditionAncestorId":"D000064419",
                "ConditionAncestorTerm":"Chemically-Induced Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M3789",
                "ConditionBrowseLeafName":"Brain Injuries",
                "ConditionBrowseLeafAsFound":"Brain Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M628",
                "ConditionBrowseLeafName":"Brain Injuries, Traumatic",
                "ConditionBrowseLeafAsFound":"Traumatic Brain Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M20421",
                "ConditionBrowseLeafName":"Substance-Related Disorders",
                "ConditionBrowseLeafAsFound":"Substance Dependence",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafAsFound":"Injury",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3786",
                "ConditionBrowseLeafName":"Brain Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4325",
                "ConditionBrowseLeafName":"Central Nervous System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7932",
                "ConditionBrowseLeafName":"Craniocerebral Trauma",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20607",
                "ConditionBrowseLeafName":"Trauma, Nervous System",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M28889",
                "ConditionBrowseLeafName":"Chemically-Induced Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3396",
                "ConditionBrowseLeafName":"Mental Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13056",
                "ConditionBrowseLeafName":"Psychotic Disorders",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC25",
                "ConditionBrowseBranchName":"Substance Related Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}