The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana
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| First Received Date ICMJE | December 25, 2005 | ||||||||
| Last Updated Date | May 6, 2008 | ||||||||
| Start Date ICMJE | July 2004 | ||||||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Brain metabolic activity (FDG) [ Time Frame: 30-40 minutes ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
Brain metabolic activity (FDG) | ||||||||
| Change History | Complete list of historical versions of study NCT00270803 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana | ||||||||
| Official Title ICMJE | The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana. | ||||||||
| Brief Summary | This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana.On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). |
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| Detailed Description | This study investigates the effects of 17mg and 13mg Delta THC on orientation and motor coordination and brain metabolic activity in regular users of marijuana. Subjects were tested twice, after smoking cigarettes with marijuana and after smoking cigarettes without marijuana. On both occasions they performed on a virtual reality maze task. They were afterwards scanned in Positron Emission Tomography (PET) with Fluoro-deoxy-glucose (FDG). 12 subjects were tested so far on both conditions. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
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| Condition ICMJE | Marijuana Dependence | ||||||||
| Intervention ICMJE | Drug: Tetra Hydro Cannabinol (THC)
Oral THC 13mg and 17mg smoked in low nicotine cigarettes
Other Name: Marijuana, cannabis |
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| Study Arm (s) | Placebo Comparator: A
Low nicotine cigarettes without THC
Intervention: Drug: Tetra Hydro Cannabinol (THC) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 12 | ||||||||
| Completion Date | December 2005 | ||||||||
| Primary Completion Date | December 2005 (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 Number ICMJE | NCT00270803 | ||||||||
| Other Study ID Numbers ICMJE | TASMC-05-EE-03-124-CTIL | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Dr. Michal Roll, Sourasky Medical Center Tel Aviv | ||||||||
| Study Sponsor ICMJE | Tel-Aviv Sourasky Medical Center | ||||||||
| Collaborators ICMJE | Hadassah Medical Organization | ||||||||
| Investigators ICMJE |
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| Information Provided By | Tel-Aviv Sourasky Medical Center | ||||||||
| Verification Date | December 2005 | ||||||||
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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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