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

Primary Purpose

Marijuana Dependence

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Tetra Hydro Cannabinol (THC)
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Marijuana Dependence focused on measuring Marijuana, FDG, PET, maze, THC, motor coordination.

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nuclear Medicine

Arms of the Study

Arm 1

Arm Type

Placebo Comparator

Arm Label

A

Arm Description

Low nicotine cigarettes without THC

Outcomes

Primary Outcome Measures

Brain metabolic activity (FDG)

Secondary Outcome Measures

Reaction time (RTs) and errors in performance
Subjective ratings on visual analog scale

Full Information

First Posted
December 25, 2005
Last Updated
May 6, 2008
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00270803
Brief Title
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana
Official Title
The Effects of Marijuana on Orientation and Motor Coordination and Brain Metabolism in Regular Smokers of Marijuana.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Hadassah Medical Organization

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Marijuana Dependence
Keywords
Marijuana, FDG, PET, maze, THC, motor coordination.

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Placebo Comparator
Arm Description
Low nicotine cigarettes without THC
Intervention Type
Drug
Intervention Name(s)
Tetra Hydro Cannabinol (THC)
Other Intervention Name(s)
Marijuana, cannabis
Intervention Description
Oral THC 13mg and 17mg smoked in low nicotine cigarettes
Primary Outcome Measure Information:
Title
Brain metabolic activity (FDG)
Time Frame
30-40 minutes
Secondary Outcome Measure Information:
Title
Reaction time (RTs) and errors in performance
Time Frame
40 minutes
Title
Subjective ratings on visual analog scale
Time Frame
10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aviv M Weinstein, Ph.D
Organizational Affiliation
Sourasky Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Einat Even-Sapir, M.D. Ph.D
Organizational Affiliation
Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nuclear Medicine
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Learn more about this trial

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

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