Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-27 @ 12:37 PM
Study NCT ID:
NCT01148992
Status:
TERMINATED
Last Update Posted:
2017-01-11
First Post:
2010-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interactions Between Intravenous (IV) Cocaine and Lofexidine
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': 'C025655', 'term': 'lofexidine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2010-06-17', 'studyFirstSubmitQcDate': '2010-06-22', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse Event and Cardiovascular Response', 'timeFrame': 'Daily, up to 9 days', 'description': 'Adverse Events will measured during follow-up at weeks 14-21'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (PK) Parameter of Cocaine and Benzoylecgonine (BE)', 'timeFrame': 'Daily, up to 9 days'}, {'measure': 'PK of Lofexidine', 'timeFrame': 'Daily, up to 9 days'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Daily, up to 9 days'}, {'measure': 'Brief Substance Abuse Craving Scale (BSCA)', 'timeFrame': 'Daily, up to 9 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cocaine Related Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess potential interactions between intravenous (IV) cocaine and treatment with lofexidine.', 'detailedDescription': 'To determine the safety of daily oral lofexidine alone and concurrent with IV cocaine infusions of 20 mg and 40 mg in cocaine-experienced, non-opiate-addicted volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be volunteers who meet Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for cocaine abuse or dependence and are non-treatment seeking at the time of the study.\n* Be between 18 and 50 years of age, inclusive.\n* Be currently use cocaine. Use must be confirmed by a positive urine test for cocaine metabolites once within the outpatient screening period.\n* Be able to verbalize understanding of the consent form and provide written informed consent.\n* Females must have a negative pregnancy test within 72 hours prior to receiving the first infusion of cocaine. They must also be postmenopausal, have had a hysterectomy, been sterilized, or agree to use one of the following methods of birth control:\n\n * diaphragm and condom by partner\n * intrauterine device (that does not contain progesterone) and condom by partner\n * sponge and condom by partner\n * complete abstinence from sexual intercourse\n\nNote: Oral contraceptives, Depo-Provera, Norplant, Patch, and intrauterine progesterone contraceptive system are not allowed.\n\nExclusion Criteria:\n\n* Please contact site for more information'}, 'identificationModule': {'nctId': 'NCT01148992', 'briefTitle': 'Interactions Between Intravenous (IV) Cocaine and Lofexidine', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Lofexidine', 'orgStudyIdInfo': {'id': 'Lofexidine-0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lofexidine', 'interventionNames': ['Drug: Lofexidine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Lofexidine', 'type': 'DRUG', 'description': '0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg', 'armGroupLabels': ['Lofexidine']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '0mg', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94110', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'California Pacific Medical Center Research Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}