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

Sponsor
Tel-Aviv Sourasky Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT00270803
Collaborator
Hadassah Medical Organization (Other)
12
Enrollment
1
Location
1
Arm
17
Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: Tetra Hydro Cannabinol (THC)
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Diagnostic
Official Title:
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana.
Study Start Date :
Jul 1, 2004
Actual Primary Completion Date :
Dec 1, 2005
Actual Study Completion Date :
Dec 1, 2005

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: A

Low nicotine cigarettes without THC

Drug: Tetra Hydro Cannabinol (THC)
Oral THC 13mg and 17mg smoked in low nicotine cigarettes
Other Names:
  • Marijuana, cannabis

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Brain metabolic activity (FDG) [30-40 minutes]

    Secondary Outcome Measures

    1. Reaction time (RTs) and errors in performance [40 minutes]

    2. Subjective ratings on visual analog scale [10 minutes]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Nuclear Medicine Tel Aviv Israel 64239

    Sponsors and Collaborators

    • Tel-Aviv Sourasky Medical Center
    • Hadassah Medical Organization

    Investigators

    • Principal Investigator: Aviv M Weinstein, Ph.D, Sourasky Medical Center
    • Principal Investigator: Einat Even-Sapir, M.D. Ph.D, Sourasky Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00270803
    Other Study ID Numbers:
    • TASMC-05-EE-03-124-CTIL
    First Posted:
    Dec 28, 2005
    Last Update Posted:
    May 7, 2008
    Last Verified:
    Dec 1, 2005
    Keywords provided by , ,
    Marijuana, FDG, PET, maze, THC, motor coordination.
    Additional relevant MeSH terms:
    Marijuana Abuse

    Study Results

    No Results Posted as of May 7, 2008