Ignite Creation Date:
2025-12-24 @ 8:01 PM
Ignite Modification Date:
2025-12-29 @ 1:46 PM
Study NCT ID:
NCT00439504
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2007-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ph1 Lobeline Interaction Study - 1
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008120', 'term': 'Lobeline'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 10}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'statusVerifiedDate': '2007-02', 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2007-02-22', 'studyFirstSubmitQcDate': '2007-02-22', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-02-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiovascular responses'}], 'secondaryOutcomes': [{'measure': 'Subjective effects'}]}, 'conditionsModule': {'conditions': ['Methamphetamine Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if there are significant cardiovascular or other interactions between sublingual lobeline and intravenous methamphetamine.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be between the ages of 18 and 45 years of age\n* Be in general good health with a history of methamphetamine (MA) abuse (but not dependence)\n* If female and of child bearing potential, agrees to use birth control\n* Be able to understand and provide written informed consent\n* Have a body mass index between 18 and 30\n* Have reported use of (MA) during the past three months without experiencing adverse consequence plus a life time MA or amphetamine use history of at least four occasions of use\n* Have a negative drug test (barbiturates, benzodiazepines, amphetamines, opiates, cocaine, cannabinoids, ethanol) at screening and at the time of admission\n\nExclusion Criteria:\n\n* Please contact site for details'}, 'identificationModule': {'nctId': 'NCT00439504', 'briefTitle': 'Ph1 Lobeline Interaction Study - 1', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Double-Blind, Placebo-Controlled, Cross-Over Assessment of Intravenous Methamphetamine and Sublingual Lobeline Interactions', 'orgStudyIdInfo': {'id': 'NIDA-CPU-0012-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lobeline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Reese Jones, M.D.', 'role': 'CONTACT', 'email': 'reese@itsa.ucsf.edu', 'phone': '415-476-7452'}], 'facility': 'Langley Porter Psychiatric Institute', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Reese Jones, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Langley Porter Psychiatric Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institute on Drug Abuse (NIDA)', 'class': 'NIH'}}}}