Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2026-01-03 @ 9:34 PM
Study NCT ID:
NCT02226367
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2014-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}, {'id': 'D003130', 'term': 'Combat Disorders'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011224', 'term': 'Prazosin'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Murray.Raskind@va.gov', 'phone': '(206) 277-3797', 'title': 'Murray Raskind, MD', 'organization': 'VA Puget Sound Health Care System'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were tracked from initiation of study drug until 30 days following study completion or termination. approximately 23 weeks.', 'description': 'This study utilized an Adverse Events Checklist of anticipated adverse events of prazosin, and open-ended adverse event reporting.', 'eventGroups': [{'id': 'EG000', 'title': 'Prazosin Hydrochloride', 'description': 'Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.\n\nprazosin hydrochloride: study drug arm prazosin', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 44, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.\n\nplacebo: study drug arm placebo', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 52, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'dizziness on standing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 18}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal Congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 18}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 16}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Palpitations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 5}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Peripheral edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depressed Mood', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 14}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'skull fracture and subdural hematoma', 'notes': 'One participant randomized to placebo suffered a fractured skull and subdural hematoma resulting from a fall while alcohol intoxicated.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Suicidal Ideation', 'notes': 'One participant was psychiatrically hospitalized for suicidal ideation.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anxiety associated with occupational stressors', 'notes': 'One participant was hospitalized due to anxiety associated with occupational stressors.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 56, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Penn Alcohol Craving Scale Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prazosin Hydrochloride', 'description': 'Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.\n\nprazosin hydrochloride: study drug arm prazosin'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.\n\nplacebo: study drug arm placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'spread': '4.1', 'groupId': 'OG000'}, {'value': '8.8', 'spread': '6.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change at Week 13 from Baseline', 'description': 'Penn Alcohol Craving Scale (PACS)\n\nThe PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prazosin Hydrochloride', 'description': 'Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.\n\nprazosin hydrochloride: study drug arm prazosin'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.\n\nplacebo: study drug arm placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '56'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Active duty soldiers participating in command mandated Army outpatient alcohol treatment were randomized to the brain-penetrant alpha-1 adrenergic receptor antagonist prazosin or placebo for 13 weeks.\n\nThe period of enrollment and completion of study procedures was January, 2015, through July, 2018.\n\nThe study was ended following enrollment of 158 participants due to end of funding.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prazosin Hydrochloride', 'description': 'Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.\n\nprazosin hydrochloride: study drug arm prazosin'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.\n\nplacebo: study drug arm placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '6.5', 'groupId': 'BG000'}, {'value': '29.8', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '29.6', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '44', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-02-26', 'size': 392563, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-04T17:48', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 158}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2018-10-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-01-17', 'studyFirstSubmitDate': '2014-07-15', 'resultsFirstSubmitDate': '2022-11-07', 'studyFirstSubmitQcDate': '2014-08-25', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-17', 'studyFirstPostDateStruct': {'date': '2014-08-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Penn Alcohol Craving Scale Score', 'timeFrame': 'Change at Week 13 from Baseline', 'description': 'Penn Alcohol Craving Scale (PACS)\n\nThe PACS is a self-report paper-and-pencil instrument. This five-item, self-report measure includes questions about the frequency, intensity, and duration of craving, the ability to resist drinking, and asks for an overall rating of craving for alcohol for the previous week. Each question is scaled from 0 to 6. Total scores are 0 to 30. Lower scores indicate less alcohol craving. Higher scores indicate more alcohol craving.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['prazosin', 'alcohol use disorders', 'posttraumatic stress disorder', 'PTSD', 'combat trauma', 'military', 'alpha-1 adrenoreceptor antagonist'], 'conditions': ['Alcohol Use Disorders', 'Stress Disorders, Posttraumatic', 'Combat Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate if the drug prazosin:\n\n* will decrease alcohol use in active duty members of the military who served in Iraq and/or Afghanistan and\n* determine if presence or absence of posttraumatic stress disorder affects treatment.', 'detailedDescription': 'The proposed study is a 19-week, titration to stable dose, randomized, two-group parallel-design, double-blind, placebo-controlled trial to evaluate the efficacy of prazosin for decreasing alcohol use in 200 active duty Service Members who served in the conflicts in Iraq and/or Afghanistan who are receiving standard outpatient treatment for alcohol use disorders at Joint Base Lewis-McChord. Treatment groups will be stratified by presence or absence of posttraumatic stress disorder (PTSD) and by assignment to the 6-week or 12-week Army Substance Abuse Program. The hypotheses are that: 1) prazosin is more effective than placebo for alcohol use disorders in these Service Members; and 2) that prazosin effect size will be greater in Service Members with PTSD than without PTSD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Male and female active duty returnees from the conflicts in Iraq and/or Afghanistan over the age of 21 with a current Diagnostic and Statistical Manual of Mental Disorders IV diagnosis of Alcohol Abuse or Dependence or a current Diagnostic and Statistical Manual of Mental Disorders 5 diagnosis of Alcohol Use Disorder\n* Participant in Army Substance Abuse Program (6 or 12 week program)\n* Recent alcohol consumption: more than 14 (women) or 21 (men) drinks per week for at least 2 weeks in the past 60 day period OR at least 2 days of heavy drinking in the past 60 day period (4 or more drinks for women and 5 or more drinks for men)\n* Good general medical health (see Exclusion Criteria below)\n* Women of childbearing potential must agree to abstain from sexual relations that could result in pregnancy or use an effective method of birth control acceptable to both participant and the study clinician during the study. Men are not required to use contraception during the study.\n* Concomitant use of naltrexone and/or antabuse must be stable for 2 weeks prior to Baseline\n* Capacity to provide informed consent\n* English fluency\n\nExclusion Criteria\n\n* Current diagnosis of opioid, methamphetamine, cocaine, marijuana, or other illegal substance dependence or abuse.\n* Signs or symptoms of alcohol withdrawal at the time of initial consent\n* Current diagnosis of schizophrenia, other psychotic disorder, manic phase of bipolar disorder, or cognitive disorder.\n* Suicide attempt or suicidal ideation with intent in the past month.\n* Significant acute or chronic medical illness, including unstable angina, recent myocardial infarction, history of congestive heart failure, preexisting hypotension (systolic \\<100) or orthostatic hypotension (defined as a systolic drop \\> 20 mmHg after two minutes standing accompanied by lightheadedness or syncope); insulin-dependent diabetes mellitus; chronic renal or hepatic failure, acute pancreatitis, Meniere's disease. Liver function tests more than 5 times the upper limit.\n* Concomitant use of trazodone (due to increased risk of priapism). There will be a two week trazodone washout period before the baseline visit.\n* Concomitant use of an alpha-1 blocker medication or insulin\n* Use of prazosin in the 4 weeks prior to Baseline.\n* History of prazosin sensitivity/allergy"}, 'identificationModule': {'nctId': 'NCT02226367', 'briefTitle': 'Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD', 'organization': {'class': 'OTHER', 'fullName': 'Seattle Institute for Biomedical and Clinical Research'}, 'officialTitle': 'Prazosin Augmentation of Outpatient Treatment of Alcohol Use Disorders in Active Duty Soldiers With and Without PTSD', 'orgStudyIdInfo': {'id': 'W81XWH-12-2-0094'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'prazosin hydrochloride', 'description': 'Prazosin hydrochloride taken orally. Titrated to a maximum dose 4 mg in the morning, 6 mg in the afternoon, and 10 mg at bedtime. (20 mg total daily at maximum dose) Dose increase will occur if the participant does not have unacceptable side effects.', 'interventionNames': ['Drug: prazosin hydrochloride']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Placebo. Oral capsule with comparable appearance to active treatment. Titrated in same manner as active treatment.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'prazosin hydrochloride', 'type': 'DRUG', 'otherNames': ['prazosin', 'Pfizer Minipress'], 'description': 'study drug arm prazosin', 'armGroupLabels': ['prazosin hydrochloride']}, {'name': 'placebo', 'type': 'DRUG', 'otherNames': ['sugar pill'], 'description': 'study drug arm placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98431', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Madigan Army Medical Center', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Murray Raskind, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Veterans Affairs Puget Sound Health Care System'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seattle Institute for Biomedical and Clinical Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States Department of Defense', 'class': 'FED'}, {'name': 'VA Puget Sound Health Care System', 'class': 'FED'}], 'responsibleParty': {'type': 'SPONSOR'}}}}