Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2026-02-20 @ 6:47 PM
Study NCT ID:
NCT00514202
Status:
TERMINATED
Last Update Posted:
2012-02-22
First Post:
2007-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-04-10', 'releaseDate': '2025-03-24'}], 'estimatedResultsFirstSubmitDate': '2025-03-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D019970', 'term': 'Cocaine-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D013035', 'term': 'Spasm'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000661', 'term': 'Amphetamine'}], 'ancestors': [{'id': 'D000662', 'term': 'Amphetamines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'Investigator left UTHSC-Houston', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-21', 'studyFirstSubmitDate': '2007-08-07', 'studyFirstSubmitQcDate': '2007-08-08', 'lastUpdatePostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substance use', 'timeFrame': 'Duration of study'}, {'measure': 'ADHD symptoms', 'timeFrame': 'Duration of study'}], 'secondaryOutcomes': [{'measure': 'Treatment retention', 'timeFrame': 'Duration of study'}, {'measure': 'Cocaine craving', 'timeFrame': 'Duration of study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['cocaine', 'ADHD', 'attention', 'hyperactivity', 'drug', 'dependence'], 'conditions': ['Attention Deficit Disorder With Hyperactivity', 'Cocaine-Related Disorders', 'Substance-Related Disorders']}, 'descriptionModule': {'briefSummary': 'Dextroamphetamine is commonly used to treat ADHD, and recent evidence suggests that this medication may decrease drug use in individuals dependent on cocaine. Thus, the present pilot study will determine the ability of dextroamphetamine to treat individuals with both cocaine dependence and ADHD.', 'detailedDescription': 'This double-blind, placebo-controlled pilot study will determine the ability of dextroamphetamine to treat comorbid cocaine dependence and ADHD. Participants will be randomly assigned on receive placebo or Dextroamphetamine SR (60 mg/day) during a 12-week study period. All participants will receive weekly cognitive behavioral therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provide informed consent\n* Generally good health except for problems related to drug use\n* Meet DSM criteria for cocaine dependence and ADHD\n* Have stable living situation\n\nExclusion Criteria:\n\n* DSM diagnosis for current psychotic, anxiety disorders as well as current substance dependence (with the exception of marijuana and nicotine)\n* Current use of prescription medications\n* Females who are currently pregnant or nursing\n* History of significant acute or chronic physical illness\n* History of or current liver disease\n* Existing cardiovascular disease\n* Plans to leave metropolitan area within 3 months\n* Probation or parole with constraints that preclude full study participation'}, 'identificationModule': {'nctId': 'NCT00514202', 'briefTitle': 'Pilot Study Examining Effect for Dextroamphetamine to Treat Cocaine Dependence Plus Attention-deficit Hyperactivity Disorder (ADHD)', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Dextroamphetamine Treatment for Comorbid Cocaine Dependence and ADHD', 'orgStudyIdInfo': {'id': 'HSC-MS-07-0024'}, 'secondaryIdInfos': [{'id': 'P50DA009262', 'link': 'https://reporter.nih.gov/quickSearch/P50DA009262', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'Placebo plus cognitive behavioral therapy', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'Dextroamphetamine SR (60 mg/kg) plus cognitive behavioral therapy', 'interventionNames': ['Drug: Dextroamphetamine SR']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'matched placebo', 'armGroupLabels': ['1']}, {'name': 'Dextroamphetamine SR', 'type': 'DRUG', 'otherNames': ['Dexedrine Spansules'], 'description': '60 mg/day', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'David V Herin, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-03-24', 'type': 'RELEASE'}, {'date': '2025-04-10', 'type': 'RESET'}], 'unpostedResponsibleParty': 'The University of Texas Health Science Center, Houston'}}}}