{
  "FullStudy":{
    "Rank":217624,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01518972",
          "OrgStudyIdInfo":{
            "OrgStudyId":"P20AA017839",
            "OrgStudyIdType":"U.S. NIH Grant/Contract",
            "OrgStudyIdLink":"https://projectreporter.nih.gov/reporterapi.cfm?PROJECTNUM=P20AA017839&Fy=all"
          },
          "Organization":{
            "OrgFullName":"Seattle Institute for Biomedical and Clinical Research",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Prazosin for Alcohol Dependence and Posttraumatic Stress Disorder",
          "OfficialTitle":"A Placebo-Controlled Trial of Prazosin in Individuals With Co-occurring Alcohol Dependence and PTSD Seeking Abstinence"
        },
        "StatusModule":{
          "StatusVerifiedDate":"August 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"August 2012",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2012",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 23, 2012",
          "StudyFirstSubmitQCDate":"January 25, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 26, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"August 13, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"August 15, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Seattle Institute for Biomedical and Clinical Research",
            "LeadSponsorClass":"OTHER"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"National Institute on Alcohol Abuse and Alcoholism (NIAAA)",
                "CollaboratorClass":"NIH"
              },{
                "CollaboratorName":"VA Puget Sound Health Care System",
                "CollaboratorClass":"FED"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"The purpose of this study is to determine whether the drug prazosin is effective for the treatment of alcohol dependency and symptoms of Posttraumatic Stress Disorder (PTSD).",
          "DetailedDescription":"Background: Alcohol dependence (AD) is a biologically, genetically based disease, yet the majority of clinically accepted treatments are behaviorally or psychosocially based. PTSD and alcohol use disorders (AUDs) commonly co-occur. This comorbidity is associated with more severe clinical impairment, shorter times to relapse, more treatment recidivism, overall greater use of treatment services, and greater treatment costs.\n\nNeuropharmacology of alcohol and prazosin: Emerging pre-clinical evidence shows that noradrenergic systems are involved in brain processes relevant to AD, such as arousal, reinforcement, and stress responsivity. However, virtually no work to date has attempted to translate this knowledge into clinically effective biological interventions. The investigators have adopted the novel, promising strategy of reducing adrenergic activity by blocking noradrenaline binding to post-synaptic alpha-1 receptors via the non-selective, alpha-1 antagonist, prazosin. Preclinical studies have demonstrated that prazosin decreases reinstatement of alcohol consumption, and preliminary clinical data suggest that prazosin reduces alcohol use in humans with AD and reduces PTSD-related nightmares and other symptoms, though it has not been tested in individuals with comorbid AD and PTSD. Prazosin, FDA approved to treat hypertension, typically has few side effects, and is inexpensive.\n\nDesign: Randomized double-blind placebo-controlled clinical trial. Participants: 60 individuals with both AD and PTSD (25% women) with stated goal to abstain from alcohol use.\n\nIntervention: Either prazosin titrated per study protocol or matched placebo for 6 weeks with Medical Management (MM) based on the COMBINE Study procedures and a final study visit two weeks after medication discontinuation.\n\nMeasures: The primary outcomes are alcohol use during the 12-week medication phase of the study and reports of craving during the same time period. Daily, prompted Interactive Voice Response (IVR) telephone monitoring will be done throughout the 8-week study to assess the primary outcomes and to provide information on affect and medication adherence. Such daily monitoring provides more accurate reports of alcohol use than standard retrospective outcome measures. Analyses: Hierarchical linear modeling to test for main effects of prazosin+MM versus placebo+MM on alcohol use and PTSD symptoms over time, and to evaluate whether reductions in PTSD mediate the effect of prazosin.\n\nFindings to date: The investigators have enrolled 30 participants and the 19 who met all the initial screening criteria were randomized overall. Since the last continuing review the investigators have enrolled 24 and randomized 15. Of the 24 participants enrolled, five are veterans and four of these has been randomized. Since the last continuing review, there have been two serious adverse events . In each case the institutional review board (IRB) review determined they were probably unrelated to the study. Enrollment continues.\n\nPublic health implications: There is a paucity of safe, tolerable, inexpensive, and efficacious drugs currently available for the treatment of AD and PTSD. Should the investigators find that prazosin leads to reduced alcohol use and PTSD symptom severity relative to placebo, clinicians will have an additional tool to help people with PTSD who are dependent on alcohol to make crucial changes in their lives."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Alcohol Abuse",
              "Posttraumatic Stress Disorder"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Alcohol",
              "Abuse",
              "Use",
              "Disorder",
              "Dependence",
              "Symptoms",
              "Alcoholic",
              "Alcoholism",
              "Prazosin",
              "Drug",
              "Medicine",
              "Medication",
              "Treatment",
              "Study",
              "Placebo",
              "Medical",
              "Management",
              "Craving",
              "Consumption",
              "Binge",
              "Drinking",
              "Drink",
              "Heavy",
              "PTSD",
              "Trauma",
              "Post",
              "Posttraumatic"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Participant",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"90",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Prazosin",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Prazosin medication",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Prazosin"
                  ]
                }
              },{
                "ArmGroupLabel":"Placebo",
                "ArmGroupType":"Placebo Comparator",
                "ArmGroupDescription":"Placebo medication",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Placebo medication"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Prazosin",
                "InterventionDescription":"Form: Prazosin will be taken orally, in the form of pills.\n\nDosing: 9 AM, 3 PM, 9 PM\n\nDays 1-2: 0 mg, 0 mg, 1 mg\n\nDays 3-4: 1 mg, 1 mg, 1 mg\n\nDays 5-7: 2 mg, 2 mg, 2 mg\n\nDay 8-10: 2 mg, 2 mg, 6 mg\n\nDay 11-14: 4 mg, 4 mg, 6 mg\n\nDay 15-84: 4 mg, 4 mg, 8 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Prazosin"
                  ]
                },
                "InterventionOtherNameList":{
                  "InterventionOtherName":[
                    "Minipress"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Placebo medication",
                "InterventionDescription":"Form: Placebo will be taken orally, in the form of pills.\n\nDosing: 9 AM, 3 PM, 9 PM\n\nDays 1-2: 0 mg, 0 mg, 1 mg\n\nDays 3-4: 1 mg, 1 mg, 1 mg\n\nDays 5-7: 2 mg, 2 mg, 2 mg\n\nDay 8-10: 2 mg, 2 mg, 6 mg\n\nDay 11-14: 4 mg, 4 mg, 6 mg\n\nDay 15-84: 4 mg, 4 mg, 8 mg",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Placebo"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Alcohol consumption and cravings",
                "PrimaryOutcomeTimeFrame":"8 weeks"
              },{
                "PrimaryOutcomeMeasure":"PTSD Symptoms",
                "PrimaryOutcomeTimeFrame":"8 weeks"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nCurrent primary DSM-IV diagnosis of alcohol dependence(AD)\nCurrent DSM-IV diagnosis of PTSD\nHeavy drinking in the last 30 days\nAt least 18 years of age\nGood general medical health (see Exclusion Criteria below)\nCapacity to provide informed consent\nEnglish fluency\n\nExclusion Criteria:\n\nPsychiatric/behavioral:\n\npsychiatric disorder requiring any medication other than anti-depressants\ncurrently taking disulfiram, acamprosate, or naltrexone or planning to take any of these medications during the 12-week medication phase of the study\ncurrent dependence on any other psychoactive substance other than nicotine or cannabis\na current diagnosis of opioid abuse, use of any opioid- containing medications or benzodiazepines during the previous month, or UDA positive for opioids, benzodiazepines, or sedative hypnotics\n\nMedical:\n\nsignificant acute or chronic medical illness; women who are pregnant, nursing infant(s), or of childbearing potential and not using a contraceptive method judged by the study physician or PA to be effective\nsigns or symptoms of alcohol withdrawal at the time of initial consent\nlegal involvement that could interfere with study treatment\nindividuals court ordered for treatment will not be eligible to participate in this study",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Tracy Simpson, PhD",
                "OverallOfficialAffiliation":"VA Puget Sound Health Care System",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"VA Puget Sound Health Care System",
                "LocationCity":"Seattle",
                "LocationState":"Washington",
                "LocationZip":"98108",
                "LocationCountry":"United States"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000011224",
                "InterventionMeshTerm":"Prazosin"
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            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000959",
                "InterventionAncestorTerm":"Antihypertensive Agents"
              },{
                "InterventionAncestorId":"D000058668",
                "InterventionAncestorTerm":"Adrenergic alpha-1 Receptor Antagonists"
              },{
                "InterventionAncestorId":"D000000317",
                "InterventionAncestorTerm":"Adrenergic alpha-Antagonists"
              },{
                "InterventionAncestorId":"D000018674",
                "InterventionAncestorTerm":"Adrenergic Antagonists"
              },{
                "InterventionAncestorId":"D000018663",
                "InterventionAncestorTerm":"Adrenergic Agents"
              },{
                "InterventionAncestorId":"D000018377",
                "InterventionAncestorTerm":"Neurotransmitter Agents"
              },{
                "InterventionAncestorId":"D000045504",
                "InterventionAncestorTerm":"Molecular Mechanisms of Pharmacological Action"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M12688",
                "InterventionBrowseLeafName":"Prazosin",
                "InterventionBrowseLeafAsFound":"Prazosin",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2858",
                "InterventionBrowseLeafName":"Antihypertensive Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19330",
                "InterventionBrowseLeafName":"Adrenergic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M2250",
                "InterventionBrowseLeafName":"Adrenergic alpha-Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19339",
                "InterventionBrowseLeafName":"Adrenergic Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19088",
                "InterventionBrowseLeafName":"Neurotransmitter Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"AnAg",
                "InterventionBrowseBranchName":"Antihypertensive Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000000437",
                "ConditionMeshTerm":"Alcoholism"
              },{
                "ConditionMeshId":"D000040921",
                "ConditionMeshTerm":"Stress Disorders, Traumatic"
              },{
                "ConditionMeshId":"D000013313",
                "ConditionMeshTerm":"Stress Disorders, Post-Traumatic"
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          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000068099",
                "ConditionAncestorTerm":"Trauma and Stressor Related Disorders"
              },{
                "ConditionAncestorId":"D000001523",
                "ConditionAncestorTerm":"Mental Disorders"
              },{
                "ConditionAncestorId":"D000019973",
                "ConditionAncestorTerm":"Alcohol-Related Disorders"
              },{
                "ConditionAncestorId":"D000019966",
                "ConditionAncestorTerm":"Substance-Related Disorders"
              },{
                "ConditionAncestorId":"D000064419",
                "ConditionAncestorTerm":"Chemically-Induced Disorders"
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            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M16268",
                "ConditionBrowseLeafName":"Wounds and Injuries",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2364",
                "ConditionBrowseLeafName":"Alcoholism",
                "ConditionBrowseLeafAsFound":"Alcohol Dependence",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M23503",
                "ConditionBrowseLeafName":"Stress Disorders, Traumatic",
                "ConditionBrowseLeafAsFound":"Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M14686",
                "ConditionBrowseLeafName":"Stress Disorders, Post-Traumatic",
                "ConditionBrowseLeafAsFound":"Posttraumatic Stress Disorder",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M27228",
                "ConditionBrowseLeafName":"Binge-Eating Disorder",
                "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"
              },{
                "ConditionBrowseLeafId":"M20426",
                "ConditionBrowseLeafName":"Alcohol-Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20421",
                "ConditionBrowseLeafName":"Substance-Related Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M28889",
                "ConditionBrowseLeafName":"Chemically-Induced Disorders",
                "ConditionBrowseLeafRelevance":"low"
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          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC25",
                "ConditionBrowseBranchName":"Substance Related Disorders"
              },{
                "ConditionBrowseBranchAbbrev":"BXM",
                "ConditionBrowseBranchName":"Behaviors and Mental Disorders"
              }
            ]
          }
        }
      }
    }
  }
}