Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 12:24 AM
Study NCT ID:
NCT00226694
Status:
COMPLETED
Last Update Posted:
2014-01-07
First Post:
2005-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alcohol and Gender Effects on Stress Circuit Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}], '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': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015283', 'term': 'Citalopram'}, {'id': 'D000073893', 'term': 'Sugars'}], 'ancestors': [{'id': 'D011437', 'term': 'Propylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D001572', 'term': 'Benzofurans'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-03', 'studyFirstSubmitDate': '2005-09-23', 'studyFirstSubmitQcDate': '2005-09-23', 'lastUpdatePostDateStruct': {'date': '2014-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'stress', 'timeFrame': 'month'}]}, 'conditionsModule': {'keywords': ['Alcoholism', 'Stress', 'Gender Differences', 'Addiction', 'Alcohol Dependence'], 'conditions': ['Alcoholism', 'Stress', 'Alcohol Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the stress hormone response to medication-induced stress and a placebo (an inactive compound) in non-drinking, recovering male and female alcoholics, with a specific emphasis on the differences between men and women in the two recovering alcoholic groups.', 'detailedDescription': 'Women and men differ in the ways stress affects the development and maintenance of alcoholism. However, no published studies in alcohol dependent patients have examined sex differences in stress responsiveness that most likely mediate these effects and influence the clinical course and treatment of the disorder.\n\nThe long-range goal of this research program is to define aspects of the neural, genetic and environmental mechanisms differentially regulating the stress response in alcohol dependent women and men. The proposed study extends prior work revealing sex-dependent alterations in basal and serotonin-induced stress hormone concentrations in abstinent alcoholics. Our central hypothesis is that sex differences in serotonin function or HPA sensitivity conspire with genetically influenced alterations in serotonin signaling to produce maladaptive stress responses in some alcoholic women. These altered stress responses may serve as the target of novel, sex-specific pharmacotherapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Able to provide written consent.\n* Are actively engaged in a recovery program for alcoholism;\n* Have a current (within the past 12 months) diagnosis of DSM-IV alcohol dependence in early- (modified to a minimum of 4 months) full remission; and\n* Are residing in a controlled sober living environment; and\n* Agree to provide at least one collateral informant who knows the subject well and can attest to their sobriety (recovering alcoholics only).\n\nExclusion Criteria:\n\n* Have evidence of any clinically significant laboratory evidence of hematologic, hepatic, cardiovascular, renal, pulmonary, thyroid or other endocrine disease;\n* Are taking oral contraceptives or other hormonal replacements (e.g., estrogen or progesterone);\n* Are pregnant, or planning to become pregnant during the next 9 months;\n* Have taken other psychotropic drugs (including SSRIs, MAO inhibitors and other antidepressants, antipsychotics, mood stabilizers, non-benzodiazepine anxiolytics or hypnotics) within 6 weeks of the first laboratory session;\n* Have taken any investigational drug within 90 days of the first laboratory session; or\n* Are making efforts to quit smoking or have taken any pharmacotherapies for smoking cessation (i.e., bupropion, nicotine-replacement patches or gum; clonidine, buspirone) within 90 days of the first laboratory session.'}, 'identificationModule': {'nctId': 'NCT00226694', 'briefTitle': 'Alcohol and Gender Effects on Stress Circuit Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Cincinnati'}, 'officialTitle': 'Alcohol and Gender Effects on Stress Circuit Function', 'orgStudyIdInfo': {'id': 'NIAAAANH013307'}, 'secondaryIdInfos': [{'id': 'R01AA013307', 'link': 'https://reporter.nih.gov/quickSearch/R01AA013307', 'type': 'NIH'}, {'id': 'NIH R01 AA013307-01'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Citalopram Group', 'description': 'Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.', 'interventionNames': ['Drug: Citalopram']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group', 'description': 'Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Citalopram', 'type': 'DRUG', 'otherNames': ['Celexa'], 'description': 'Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.', 'armGroupLabels': ['Citalopram Group']}, {'name': 'Placebo', 'type': 'OTHER', 'otherNames': ['Sugar Pill'], 'description': 'Subjects receive provocative tests with citalopram, dexamethasone/corticotropin-releasing hormone and placebo on 3 separate, counterbalanced occasions at monthly intervals.', 'armGroupLabels': ['Placebo Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45220', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Department of Veterans Affairs / Veterans Healthcare System of Ohio', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}], 'overallOfficials': [{'name': 'Robert M. Anthenelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'US Department of Veterans Affairs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Cincinnati', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}