Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 10:26 PM
Study NCT ID:
NCT00254358
Status:
TERMINATED
Last Update Posted:
2008-07-04
First Post:
2005-11-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Brain Imaging Study of Nicotine Release in Cigarette Smokers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'It was decided to use a different protocol with a different radioligand', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-06', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-03', 'studyFirstSubmitDate': '2005-11-15', 'studyFirstSubmitQcDate': '2005-11-15', 'lastUpdatePostDateStruct': {'date': '2008-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-16', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nicotine', 'Dopamine', 'IBZM'], 'conditions': ['Nicotine Dependence']}, 'descriptionModule': {'briefSummary': 'Tobacco Smoking is the most prevalent addiction in society today causing directly major health hazards and sharing morbidity with other psychiatric disorders. Nicotine binds to acetylcholine receptors and thus elevates DA release and inhibits DA transport. There are few studies using advanced brain imaging techniques to investigate how nicotine releases dopamine in humans. These studies utilized dopamine displacement paradigms with \\[11C\\] Raclopride binding to D2 receptor in Positron Emission Tomography (PET). There is evidence that smokers (particularly those who enjoyed smoking) showed decreased \\[11C\\] Raclopride binding in the caudate/nucleus accumbens and putamen after smoking cigarettes. These results also indicated that the effects of nicotine on dopaminergic neurotransmission are mediated by pleasure and craving. We propose to investigate the effects of smoking a cigarette ad lib on dopamine release by using dopamine competition paradigm with \\[I123\\] IBZM in SPECT. Secondly, we will test the hypothesis that dopamine deficiency is a major vulnerability factor for smoking. This may provide further evidence that dopamine deficiency in some smokers pre-disposes them to enjoy and desire smoking cigarettes more than others.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'smokers in treatment with bupropion', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Chronic smokers and healthy non-smokers.\n\nExclusion Criteria:\n\n* Pregnant and breast feeding women.\n* Age below 20.\n* Neurological disorders.\n* Others drugs.'}, 'identificationModule': {'nctId': 'NCT00254358', 'briefTitle': 'A Brain Imaging Study of Nicotine Release in Cigarette Smokers', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'A Brain Imaging Study of Nicotine Release in Cigarette Smokers', 'orgStudyIdInfo': {'id': '842902-HMO-CTIL'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Yodphat Krausz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'Herzog Hospital', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Aviv Weinstein', 'oldOrganization': 'Hadassah Medical Organization'}}}}