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

This study has been completed.
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT00270803
First received: December 25, 2005
Last updated: May 6, 2008
Last verified: December 2005
  Purpose

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 Intervention
Marijuana Dependence
Drug: Tetra Hydro Cannabinol (THC)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:


Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Brain metabolic activity (FDG) [ Time Frame: 30-40 minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reaction time (RTs) and errors in performance [ Time Frame: 40 minutes ] [ Designated as safety issue: No ]
  • Subjective ratings on visual analog scale [ Time Frame: 10 minutes ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: July 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: December 25, 2005
Last Updated: May 6, 2008
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

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

ClinicalTrials.gov processed this record on September 22, 2014