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| Tracking Information | |||||||||||||
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| First Received Date ICMJE | December 20, 2005 | ||||||||||||
| Last Updated Date | May 6, 2008 | ||||||||||||
| Start Date ICMJE | July 2004 | ||||||||||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Brain metabolic activity (FDG) in response to craving and neutral cues. [ Time Frame: 30-40 minutes ] [ Designated as safety issue: No ] | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Brain metabolic activity (FDG) in response to craving and neutral cues. | ||||||||||||
| Change History | Complete list of historical versions of study NCT00267813 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Subjective ratings of craving [ Time Frame: 10 minutes ] [ Designated as safety issue: No ] | ||||||||||||
| Original Secondary Outcome Measures ICMJE |
Subjective ratings of craving | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers | ||||||||||||
| Official Title ICMJE | The Effects of Craving and Abstinence From Cigarettes on Brain Metabolism in Smokers. | ||||||||||||
| Brief Summary | Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban). We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity in response to smoking and neutral cues in Positron Emission Tomography using FDG. |
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| Detailed Description | Craving and withdrawal from smoking cigarettes are major factors for relapse. We investigated craving for cigarettes in smokers undergoing pharmacological treatment with Bupropion (Zyban)for 2 months. We compare cue-induced reactivity to smoking videos in smokers who were successfully treated with Bupropion to smokers who are still smoking. We measured the brain's metabolic activity after exposure to videotapes showing smoking and neutral scenes in Positron Emission Tomography using FDG. There were 2 scanning sessions, one with a smoking videotape and one with a neutral video separated by a week. So far we have compared the brain's metabolic activity in 6 abstinent smokers and 6 still smokers. |
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| Study Phase | |||||||||||||
| Study Type ICMJE | Interventional | ||||||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Pharmacodynamics Study | ||||||||||||
| Condition ICMJE | Nicotine Dependence | ||||||||||||
| Intervention ICMJE | Drug: Bupropion (Zyban) | ||||||||||||
| Study Arms / Comparison Groups | |||||||||||||
| Publications * | |||||||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 24 | ||||||||||||
| Completion Date | October 2007 | ||||||||||||
| Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 20 Years to 65 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | Israel | ||||||||||||
| Administrative Information | |||||||||||||
| NCT ID ICMJE | NCT00267813 | ||||||||||||
| Responsible Party | Dr. Aviv M. Weinstein, Sourasky Medical Center Tel Aviv | ||||||||||||
| Study ID Numbers ICMJE | TASMC-O5-EE-065-CTIL | ||||||||||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||||||||||
| Collaborators ICMJE | |||||||||||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||||||||||
| Verification Date | May 2008 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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