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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:
Information provided by:

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
Marijuana Dependence Drug: Tetra Hydro Cannabinol (THC)

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  (Clinical Trial)
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 : July 2004
Primary Completion Date : December 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana
U.S. FDA Resources

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 Name: Marijuana, cannabis


Outcome Measures

Primary Outcome Measures :
  1. Brain metabolic activity (FDG) [ Time Frame: 30-40 minutes ]

Secondary Outcome Measures :
  1. Reaction time (RTs) and errors in performance [ Time Frame: 40 minutes ]
  2. Subjective ratings on visual analog scale [ Time Frame: 10 minutes ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00270803


Locations
Israel
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
More Information

Responsible Party: Dr. Michal Roll, Sourasky Medical Center Tel Aviv
ClinicalTrials.gov Identifier: NCT00270803     History of Changes
Other Study ID Numbers: TASMC-05-EE-03-124-CTIL
First Posted: December 28, 2005    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: December 2005

Keywords provided by Tel-Aviv Sourasky Medical Center:
Marijuana, FDG, PET, maze, THC, motor coordination.

Additional relevant MeSH terms:
Marijuana Abuse
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders