NCT00270803

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2004

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

December 25, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 28, 2005

Completed
Last Updated

May 7, 2008

Status Verified

December 1, 2005

Enrollment Period

1.4 years

First QC Date

December 25, 2005

Last Update Submit

May 6, 2008

Conditions

Marijuana Dependence

Keywords

Marijuana, FDG, PET, maze, THC, motor coordination.

Outcome Measures

Primary Outcomes (1)

  • Brain metabolic activity (FDG)

    30-40 minutes

Secondary Outcomes (2)

  • Reaction time (RTs) and errors in performance

    40 minutes

  • Subjective ratings on visual analog scale

    10 minutes

Study Arms (1)

A

PLACEBO COMPARATOR

Low nicotine cigarettes without THC

Drug: Tetra Hydro Cannabinol (THC)

Interventions

Tetra Hydro Cannabinol (THC)DRUG

Oral THC 13mg and 17mg smoked in low nicotine cigarettes

Also known as: Marijuana, cannabis
A

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Marijuana dependence
  • Age 20-65
  • Male and female

You may not qualify if:

  • Pregnant women
  • Dependence on other substances
  • Psychiatric diagnosis apart from marijuana dependence
  • Neurological disorder
  • Young persons

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Nuclear Medicine

Tel Aviv, 64239, Israel

Location

MeSH Terms

Conditions

Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Aviv M Weinstein, Ph.D

    Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

  • Einat Even-Sapir, M.D. Ph.D

    Sourasky Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 25, 2005

First Posted

December 28, 2005

Study Start

July 1, 2004

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

May 7, 2008

Record last verified: 2005-12

Locations

IL(1)