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The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana

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ClinicalTrials.gov Identifier: NCT00270803
Recruitment Status : Completed
First Posted : December 28, 2005
Last Update Posted : May 7, 2008
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by:
Tel-Aviv Sourasky Medical Center

Tracking Information
First Submitted Date  ICMJE December 25, 2005
First Posted Date  ICMJE December 28, 2005
Last Update Posted Date May 7, 2008
Study Start Date  ICMJE July 2004
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
Brain metabolic activity (FDG) [ Time Frame: 30-40 minutes ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 25, 2005)
Brain metabolic activity (FDG)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 6, 2008)
  • Reaction time (RTs) and errors in performance [ Time Frame: 40 minutes ]
  • Subjective ratings on visual analog scale [ Time Frame: 10 minutes ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 25, 2005)
  • Reaction time (RTs) and errors in performance
  • Subjective ratings on visual analog scale
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures 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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
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
Study Arms  ICMJE Placebo Comparator: A
Low nicotine cigarettes without THC
Intervention: Drug: Tetra Hydro Cannabinol (THC)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 25, 2005)
12
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2005
Actual Primary Completion Date December 2005   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Marijuana dependence
  • Age 20-65
  • Male and female

Exclusion Criteria:

  • Pregnant women
  • Dependence on other substances
  • Psychiatric diagnosis apart from marijuana dependence
  • Neurological disorder
  • Young persons
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00270803
Other Study ID Numbers  ICMJE TASMC-05-EE-03-124-CTIL
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
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
Principal Investigator: Aviv M Weinstein, Ph.D Sourasky Medical Center
Principal Investigator: Einat Even-Sapir, M.D. Ph.D Sourasky Medical Center
PRS Account Tel-Aviv Sourasky Medical Center
Verification Date December 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP