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Processing and Effects of Cannabis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00225407
Recruitment Status : Unknown
Verified March 2005 by UMC Utrecht.
Recruitment status was:  Recruiting
First Posted : September 23, 2005
Last Update Posted : September 23, 2005
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
UMC Utrecht

Brief Summary:
The purpose of this study is to investigate the processing of cannabis, and to investigate the occurrence of effects of cannabis on the cardiovascular system and the central nervous system; at higher levels of exposure.

Condition or disease Intervention/treatment Phase
Hypotension Tachycardia Drug: Smoking of cannabis cigarettes (different strength) Phase 1

Detailed Description:
In Europe, cannabis is the most illicit used drug, mainly for its psychoactive properties (becoming "high" or "stoned"). The active compound in cannabis is THC (tetrahydrocannabinol). In recent years the strength of cannabis (marihuana) available on the market in the Netherland has increased (especially "netherweed"). The THC-content has increased from on average 8.6% in 2000 to on average 20.3% in 2004. Experienced users adapt their habit of smoking to the strength of the cannabis sigaret (joint). However, there is also a group of people, mainly young ones, who intent to smoke the joint entirely, and can therefore be exposed to higher levels of THC. Information is lacking about the effects of cannabis at higher levels of exposure. Because of this, the Ministry of Health, Welfare, and Sports of the Netherlands ordered the investigators to perform a study to gain more insight in this issue.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 27 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis
Study Start Date : July 2005
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Marijuana

Primary Outcome Measures :
  1. Serum concentration over time
  2. Physical parameters (heart rate, blood pressure)
  3. Psychomotor tests (such continuous attention)
  4. Event related potentials

Secondary Outcome Measures :
  1. Self-reporting questionnaires

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Cannabis users (2-9 joints per month)

Exclusion Criteria:

  • Psychiatric illness
  • Evidence of excessive alcohol abuse
  • Use of other drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00225407

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Contact: Tjeert T Mensinga, MD, PhD +31 30 2507340

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University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Tjeert T Mensinga, MD, PhD    +31 30 2507340   
Principal Investigator: Tjeert T Mensinga, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Netherlands: Ministry of Health, Welfare and Sports
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Principal Investigator: Tjeert T Mensinga, MD, PhD National Institute of Public Health and the Environment, the Netherlands

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00225407    
Other Study ID Numbers: V/267002
First Posted: September 23, 2005    Key Record Dates
Last Update Posted: September 23, 2005
Last Verified: March 2005
Keywords provided by UMC Utrecht:
Psychomotor tests
Event related potentials
Additional relevant MeSH terms:
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Marijuana Abuse
Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiac Conduction System Disease
Pathologic Processes
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders