Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-07 @ 5:39 AM
Study NCT ID:
NCT00519259
Status:
UNKNOWN
Last Update Posted:
2017-01-11
First Post:
2006-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 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': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2006-02'}, 'statusVerifiedDate': '2006-06', 'lastUpdateSubmitDate': '2017-01-10', 'studyFirstSubmitDate': '2006-06-29', 'studyFirstSubmitQcDate': '2007-08-21', 'lastUpdatePostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability'}], 'secondaryOutcomes': [{'measure': 'Safety'}, {'measure': 'Pharmacokinetic parameters'}, {'measure': 'Cardiovascular responses'}, {'measure': 'Psychological effects of lobeline'}]}, 'conditionsModule': {'conditions': ['Methamphetamine Dependence']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and pharmacokinetics of sublingual lobeline in healthy normal volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be able to provide written informed consent\n* Must have a body mass index between 18 and 30\n* Have no medical contraindications as determined by medical history, physical exam, ECG, hematology and blood chemistry profile, and urinalysis\n* Must have a negative drug test at screening and admission\n* If female of child bearing potential, must agree to use birth control\n\nExclusion Criteria:\n\n* Please contact the site for more information'}, 'identificationModule': {'nctId': 'NCT00519259', 'briefTitle': 'Tolerability and Safety of 30, 45, and 60 mg of Sublingual Lobeline. - 1', 'organization': {'class': 'NIH', 'fullName': 'National Institute on Drug Abuse (NIDA)'}, 'officialTitle': 'Tolerability, Safety, and Pharmacokinetics of Repeated Sublingual Doses of Lobeline', 'orgStudyIdInfo': {'id': 'NIDA-CPU-0009-1'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Lobeline', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', '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'}}}}