Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT00656357
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2008-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019970', 'term': 'Cocaine-Related Disorders'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003042', 'term': 'Cocaine'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D014326', 'term': 'Tropanes'}, {'id': 'D053961', 'term': 'Azabicyclo Compounds'}, {'id': 'D001372', 'term': 'Aza Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D019086', 'term': 'Bridged Bicyclo Compounds, Heterocyclic'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'dispFirstSubmitDate': '2009-12-03', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-15', 'studyFirstSubmitDate': '2008-04-04', 'dispFirstSubmitQcDate': '2009-12-03', 'studyFirstSubmitQcDate': '2008-04-04', 'dispFirstPostDateStruct': {'date': '2009-12-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2018-08-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine the safety of treatment with SYN117 in cocaine-dependent volunteers by measuring hemodynamic and subjective effects of administration of ascending doses of cocaine(10mg, 20mg, 40mg)and placebo during treatment with ascending doses of SYN117.', 'timeFrame': 'inpatient 14 days with 2 week outpatient follow-up'}], 'secondaryOutcomes': [{'measure': 'Determine tolerability by measuring adverse events', 'timeFrame': 'inpatient 14 days, 2 weeks post followup visit'}, {'measure': 'Determine subjective effects produced by self administration of cocaine or placebo', 'timeFrame': 'Days 4, 8, 12 and 13'}, {'measure': 'Determine the effect of SYN117 of the pharmacokinetics of IV cocaine', 'timeFrame': 'Days 3 and 11'}, {'measure': 'Determine if any baseline measures of impulsivity or drug use severity predict efficacy of SYN117 in reducing subjective effects of cocaine', 'timeFrame': 'Days 4, 8 and 12'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cocaine Dependence']}, 'descriptionModule': {'briefSummary': 'This study will assess the potential interaction and subjective effects between intravenous cocaine and SYN117 in non-treatment seeking cocaine dependant subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non treatment seeking cocaine dependent\n* English speaking\n* meet DSM IV TR criteria for cocaine dependence\n* pulse 50-90bpm\n* systolic BP 85-140 mmHg\n* diastolic BP 45-90 mmHg\n* essentially normal liver and kidney function blood tests\n* ECG normal\n* sign informed consent\n* negative urine pregnancy test at screening and admission\n\nExclusion Criteria:\n\n* history or evidence of seizure disorder or brain injury\n* previous medically adverse reaction to cocaine, including loss of consciousness, chest pain or epileptic seizure\n* neurological disorders, organic brain disease, dementia\n* psychiatric disorders such as psychosis, schizophrenia, bipolar disorder, major depression\n* history of suicide attempts within past 3 months or suicidal ideation/plan\n* history of clinically significant heart disease or hypertension\n* family history in 1st degree relatives of early cardiovascular morbidity or mortality\n* untreated or unstable medical conditions\n* positive HIV test\n* pregnant or nursing\n* have asthma or are currently using alpha, beta agonists or theophylline or other sympathomimetics\n* test positive for other drugs of abuse with the exception of cocaine, cocaine metabolites or marijuana\n* any other illness, condition or use of psychotropic medications which preclude safe/successful completion of the study\n* currently on parole'}, 'identificationModule': {'nctId': 'NCT00656357', 'briefTitle': 'Study of Safety and Potential Efficacy of SYN117 in Cocaine Dependent Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biotie Therapies Inc.'}, 'officialTitle': 'A Human Laboratory Assessment of the Safety and Potential Efficacy of SYN117 (Nepicastat) in Cocaine-dependent Volunteers Receiving Cocaine', 'orgStudyIdInfo': {'id': 'SYN117-CL01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A', 'description': 'SYN117 placebo and Ascending doses of cocaine (10, 20, 40 mg) and placebo', 'interventionNames': ['Drug: SYN117 Placebo', 'Drug: Cocaine 10mg', 'Drug: Cocaine 20mg', 'Drug: Cocaine 40mg', 'Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'Ascending doses of SYN117 (placebo, 80 mg, 160 mg) and ascending doses of cocaine (10 mg, 20 mg, 40 mg) and placebo', 'interventionNames': ['Drug: SYN117 80 mg', 'Drug: SYN117 160 mg', 'Drug: Cocaine 10mg', 'Drug: Cocaine 20mg', 'Drug: Cocaine 40mg', 'Drug: Saline']}], 'interventions': [{'name': 'SYN117 Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['A']}, {'name': 'SYN117 80 mg', 'type': 'DRUG', 'description': 'SYN117 80 mg', 'armGroupLabels': ['B']}, {'name': 'SYN117 160 mg', 'type': 'DRUG', 'description': 'SYN117 160 mg', 'armGroupLabels': ['B']}, {'name': 'Cocaine 10mg', 'type': 'DRUG', 'description': 'IV Cocaine 10mg', 'armGroupLabels': ['A', 'B']}, {'name': 'Cocaine 20mg', 'type': 'DRUG', 'description': 'IV Cocaine 20mg', 'armGroupLabels': ['A', 'B']}, {'name': 'Cocaine 40mg', 'type': 'DRUG', 'description': 'IV Cocaine 40mg', 'armGroupLabels': ['A', 'B']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'IV Cocaine Placebo', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch (UTMB)', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Stephen Bandak, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Biotie Therapies Inc.'}, {'name': 'F. Gerald Moeller, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'UTSW-Houston'}, {'name': 'Kathryn Cunningham, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB-Galveston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biotie Therapies Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}