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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00270803
Other study ID # TASMC-05-EE-03-124-CTIL
Secondary ID
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


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
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