Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-02-26 @ 12:40 AM
Study NCT ID:
NCT00626834
Status:
COMPLETED
Last Update Posted:
2017-01-12
First Post:
2008-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vigabatrin Ph 1 Cocaine Interaction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D016739', 'term': 'Behavior, Addictive'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D003192', 'term': 'Compulsive Behavior'}, {'id': 'D007175', 'term': 'Impulsive Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020888', 'term': 'Vigabatrin'}], 'ancestors': [{'id': 'D005680', 'term': 'gamma-Aminobutyric Acid'}, {'id': 'D000613', 'term': 'Aminobutyrates'}, {'id': 'D002087', 'term': 'Butyrates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-11', 'studyFirstSubmitDate': '2008-02-18', 'studyFirstSubmitQcDate': '2008-02-28', 'lastUpdatePostDateStruct': {'date': '2017-01-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'safety/tolerability and AE assessments including HR/BP/ECG/QTc', 'timeFrame': '56 days'}], 'secondaryOutcomes': [{'measure': 'VGB/PK during cocaine infusions and effect of VGB on cocaine craving', 'timeFrame': '28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cocaine addiction', 'vigabatrin', 'ovation pharmaceuticals', 'cocaine', 'cocaine related disorders', 'behavior addictive', 'mental disorders', 'therapeutic uses', 'physiologic effects of drugs', 'disorder of environmental origin', 'central nervous system stimulants', 'central nervous system agents', 'pharmacological actions', 'substance related disorders'], 'conditions': ['Cocaine Addiction']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1 safety/tolerably study to determine if there are clinically significant interactions between oral vigabatrin (gamma vinyl-gamma-amino butyric acid; VGB) concurrent with intravenous (IV) cocaine infusions.', 'detailedDescription': 'STUDY DESIGN: This is a randomized, double-blind, placebo-controlled, parallel group study of the effects of VGB compared to placebo control on the physiological and subjective effects of IV infusions of cocaine (cocaine experienced volunteers).\n\nSubjects will be randomized within each clinical site to one of four groups (placebo control or one of three doses of VGB twice daily).During VGB steady state dosing, subjects will receive double-blind infusions of saline and cocaine. Subjects will be asked to return for follow-up approximately 7 and 14 days after the day of clinic discharge.\n\nSTUDY DURATION: The maximum duration is 56 days, including 14 inpatient days of assessments and investigational products administration, and two follow-up visits after clinic discharge.\n\nSAMPLE SIZE: Twenty-four subjects will be randomized to one of three doses of vigabatrin or placebo.\n\nPOPULATION: Volunteer, cocaine-experienced, non-treatment seeking cocaine users, 18 to 45 years of age.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between 18 and 45 years of age, inclusive\n* Currently be a non-treatment seeking cocaine user as confirmed by a positive urine test for cocaine\n* Able to provide written informed consent\n* A negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine\n\nExclusion Criteria:\n\nPlease contact site for more information.'}, 'identificationModule': {'nctId': 'NCT00626834', 'briefTitle': 'Vigabatrin Ph 1 Cocaine Interaction Study', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Intravenous Cocaine and Oral Gamma Vinyl-Gamma-Amino Butyric Acid (VIGABATRIN) Interaction Study', 'orgStudyIdInfo': {'id': 'OV-1014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vigabatrin Dose 1', 'interventionNames': ['Drug: Vigabatrin']}, {'type': 'EXPERIMENTAL', 'label': 'Vigabatrin Dose 2', 'interventionNames': ['Drug: Vigabatrin']}, {'type': 'EXPERIMENTAL', 'label': 'Vigabatrin Dose 3', 'interventionNames': ['Drug: Vigabatrin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Matching placebo', 'interventionNames': ['Drug: Matching placebo']}], 'interventions': [{'name': 'Vigabatrin', 'type': 'DRUG', 'description': 'Dose 1 BID', 'armGroupLabels': ['Vigabatrin Dose 1']}, {'name': 'Vigabatrin', 'type': 'DRUG', 'description': 'Dose 2 BID', 'armGroupLabels': ['Vigabatrin Dose 2']}, {'name': 'Vigabatrin', 'type': 'DRUG', 'description': 'Dose 3 BID', 'armGroupLabels': ['Vigabatrin Dose 3']}, {'name': 'Matching placebo', 'type': 'DRUG', 'description': 'Matching placebo BID', 'armGroupLabels': ['Matching placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'John D. Roache, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}, {'name': 'Nora Chiang, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Drug Abuse (NIDA)'}, {'name': 'Ahmed Elkashef, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Drug Abuse (NIDA)'}, {'name': 'Roberta Kahn, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Institute on Drug Abuse (NIDA)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}