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

Marijuana Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270803
• Other study ID #: TASMC-05-EE-03-124-CTIL
• Status: Completed
• Phase: N/A
• First received: December 25, 2005
• Last updated: May 6, 2008
• Start date: July 2004
• Est. completion date: December 2005

Study information

• Verified date: December 2005
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Marijuana Abuse
• Marijuana Dependence

Intervention

Drug:
• Tetra Hydro Cannabinol (THC)
Oral THC 13mg and 17mg smoked in low nicotine cigarettes

Locations

Country	Name	City	State
Israel	Department of Nuclear Medicine	Tel Aviv

Sponsors (2)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center	Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Brain metabolic activity (FDG)		30-40 minutes	No
Secondary	Reaction time (RTs) and errors in performance		40 minutes	No
Secondary	Subjective ratings on visual analog scale		10 minutes	No