{ "FullStudy":{ "Rank":217720, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01517711", "OrgStudyIdInfo":{ "OrgStudyId":"INTRuST-Tramadol" }, "Organization":{ "OrgFullName":"INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium", "OrgClass":"OTHER" }, "BriefTitle":"Tramadol Extended-Release (ER) for Posttraumatic Stress Disorder (PTSD)", "OfficialTitle":"A Double-Blind, Placebo-Controlled, Flexible-Dose Pilot Clinical Trial of Once-Daily Extended-Release Tramadol for the Treatment of PTSD" }, "StatusModule":{ "StatusVerifiedDate":"January 2015", "OverallStatus":"Unknown status", "LastKnownStatus":"Active, not recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"September 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"September 2014", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"July 2015", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 24, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 25, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 12, 2015", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 14, 2015", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium", "LeadSponsorClass":"OTHER" }, "CollaboratorList":{ "Collaborator":[ { "CollaboratorName":"U.S. Army Medical Research and Development Command", "CollaboratorClass":"FED" } ] } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"This is a six-week pilot study testing the efficacy of tramadol extended-release (ER) for posttraumatic stress disorder (PTSD). Men and women aged 21-55 years with combat-related PTSD (n = more than 20) or PTSD resulting from a civilian trauma (n = fewer than 20) will be recruited. Blinded tramadol ER will begin with a 100 mg daily dose for the first week, with an option to increase to 200 mg/day for the 2nd week. Dose adjustments, using a range of 100-300 mg tramadol ER per day (or 1 to 3 placebo tabs), are permitted thereafter. The primary hypothesis is that tramadol ER 100 to 300 mg every morning for 6 weeks will reduce the symptoms of PTSD relative to placebo. The primary outcome measures will be PTSD symptoms as rated by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions scale at baseline and weeks one, two, four, and six. Assignment to blinded medication arms will be stratified to ensure equivalence of the two arms (men and women, military and civilian trauma)." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Post-Traumatic Stress Disorder" ] }, "KeywordList":{ "Keyword":[ "pharmacotherapy", "combat disorders" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"40", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Tramadol ER", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Tramadol" ] } },{ "ArmGroupLabel":"Sugar pill", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Tramadol", "InterventionDescription":"Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Tramadol ER" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Ultram® ER" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sugar pill" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Efficacy as measured by a reduction in PTSD symptoms.", "PrimaryOutcomeDescription":"Efficacy will be determined by change in PTSD symptoms as measured by the Clinician-Administered PTSD Scale (CAPS) and Clinicians Global Impressions scale.", "PrimaryOutcomeTimeFrame":"Baseline and weeks 1, 2, 4, and 6" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Efficacy as measured by a reduction in anxiety, \"nervousness\", irritability, mood, sleep, and pain.", "SecondaryOutcomeDescription":"Efficacy will be determined by change in anxiety, \"nervousness\", irritability, mood, sleep, and pain as measured by self-rated 100-mm visual analog scales.", "SecondaryOutcomeTimeFrame":"Baseline and weeks 1, 2, 4, and 6." },{ "SecondaryOutcomeMeasure":"Efficacy as measured by a reduction in depressive symptoms.", "SecondaryOutcomeDescription":"Efficacy will be determined by change in depressive symptoms as measured by the Quick Inventory of Depressive Symptoms - Self Report.", "SecondaryOutcomeTimeFrame":"Baseline and weeks 1, 2, 4, and 6." } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nMen and women, military veterans and non-veterans, aged 21-55 years\nActive PTSD as determined by diagnostic evaluation and standardized interview (Structured Clinical Interview for the DSM (SCID))\nLiteracy and ability to give informed consent\nIn women of child-conceiving potential, a negative pregnancy test and use of an approved birth control method\nGlasgow Coma Scale (GCS) score of 15, Extension of GCS with 7-point Amnesia Scale score of 6 (amnesia for traumatic event of 30 min or fewer) or 7 (no amnesia for impact of head) (Nell et al 2000)\nClinically judged to be at low risk for adverse sequelae from taking tramadol\nConcomitant medications must be approved by the PI\n\nExclusion Criteria:\n\nPregnant or nursing women\nHomeless persons\nSuicidal or homicidal ideation with plans or intent\nHistory of opioid dependence or abuse\nPsychosis or history thereof, substance dependence or abuse (other than tobacco dependence; lifetime opioid abuse is exclusionary) within the past 60 days, anorexia nervosa, antisocial personality disorder, or other psychiatric disorder judged by the investigator to be more clinically significant than PTSD\nSerious or unstable illness, endocrinopathy, or metabolic instability, including renal insufficiency, liver disease, hydrocephalus, history of stroke, history of seizures, history of brain tumor\nUse of non-study medications except those approved by the PI\nNewly started in psychotherapy (< 3months)\nHistory of hypersensitivity, allergy, or other significant adverse effects from tramadol", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"21 Years", "MaximumAge":"55 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Thomas Geracioti, MD", "OverallOfficialAffiliation":"University of Cincinnati", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Cincinnati VA Medical Center", "LocationCity":"Cincinnati", "LocationState":"Ohio", "LocationZip":"45220", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25166484", "ReferenceType":"derived", "ReferenceCitation":"Geracioti TD. Tramadol treatment of combat-related posttraumatic stress disorder. Ann Clin Psychiatry. 2014 Aug;26(3):217-21." } ] } } }, "AnnotationSection":{ "AnnotationModule":{ "UnpostedAnnotation":{ "UnpostedResponsibleParty":"INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium", "UnpostedEventList":{ "UnpostedEvent":[ { "UnpostedEventType":"Release", "UnpostedEventDate":"February 29, 2016" },{ "UnpostedEventType":"Reset", "UnpostedEventDate":"March 29, 2016" } ] } } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "InterventionBrowseModule":{ "InterventionMeshList":{ "InterventionMesh":[ { "InterventionMeshId":"D000014147", "InterventionMeshTerm":"Tramadol" } ] }, "InterventionAncestorList":{ "InterventionAncestor":[ { "InterventionAncestorId":"D000000701", "InterventionAncestorTerm":"Analgesics, Opioid" },{ "InterventionAncestorId":"D000009294", "InterventionAncestorTerm":"Narcotics" },{ "InterventionAncestorId":"D000002492", "InterventionAncestorTerm":"Central Nervous System Depressants" },{ "InterventionAncestorId":"D000045505", "InterventionAncestorTerm":"Physiological Effects of Drugs" },{ "InterventionAncestorId":"D000000700", "InterventionAncestorTerm":"Analgesics" },{ "InterventionAncestorId":"D000018689", "InterventionAncestorTerm":"Sensory System Agents" },{ "InterventionAncestorId":"D000018373", "InterventionAncestorTerm":"Peripheral Nervous System Agents" } ] }, "InterventionBrowseLeafList":{ "InterventionBrowseLeaf":[ { "InterventionBrowseLeafId":"M15484", "InterventionBrowseLeafName":"Tramadol", "InterventionBrowseLeafAsFound":"Tramadol", "InterventionBrowseLeafRelevance":"high" },{ "InterventionBrowseLeafId":"M2614", "InterventionBrowseLeafName":"Analgesics, Opioid", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M2613", "InterventionBrowseLeafName":"Analgesics", "InterventionBrowseLeafRelevance":"low" },{ "InterventionBrowseLeafId":"M10828", "InterventionBrowseLeafName":"Narcotics", "InterventionBrowseLeafRelevance":"low" } ] }, "InterventionBrowseBranchList":{ "InterventionBrowseBranch":[ { "InterventionBrowseBranchAbbrev":"Analg", "InterventionBrowseBranchName":"Analgesics" },{ "InterventionBrowseBranchAbbrev":"CNSDep", "InterventionBrowseBranchName":"Central Nervous System Depressants" },{ "InterventionBrowseBranchAbbrev":"All", "InterventionBrowseBranchName":"All Drugs and Chemicals" } ] } }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000040921", "ConditionMeshTerm":"Stress Disorders, Traumatic" },{ "ConditionMeshId":"D000013313", "ConditionMeshTerm":"Stress Disorders, Post-Traumatic" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000068099", "ConditionAncestorTerm":"Trauma and Stressor Related Disorders" },{ "ConditionAncestorId":"D000001523", "ConditionAncestorTerm":"Mental Disorders" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M23503", "ConditionBrowseLeafName":"Stress Disorders, Traumatic", "ConditionBrowseLeafAsFound":"Stress Disorder", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M14686", "ConditionBrowseLeafName":"Stress Disorders, Post-Traumatic", "ConditionBrowseLeafAsFound":"Post Traumatic Stress Disorder", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M4941", "ConditionBrowseLeafName":"Combat Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M16268", "ConditionBrowseLeafName":"Wounds and Injuries", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M222", "ConditionBrowseLeafName":"Trauma and Stressor Related Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M3396", "ConditionBrowseLeafName":"Mental Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M13056", "ConditionBrowseLeafName":"Psychotic Disorders", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BXM", "ConditionBrowseBranchName":"Behaviors and Mental Disorders" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }