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Processing and Effects of Cannabis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2005 by UMC Utrecht.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Netherlands: Ministry of Health, Welfare and Sports
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00225407
First received: September 21, 2005
Last updated: NA
Last verified: March 2005
History: No changes posted

September 21, 2005
September 21, 2005
July 2005
Not Provided
  • Serum concentration over time
  • Physical parameters (heart rate, blood pressure)
  • Psychomotor tests (such continuous attention)
  • Event related potentials
Same as current
No Changes Posted
Self-reporting questionnaires
Same as current
Not Provided
Not Provided
 
Processing and Effects of Cannabis
A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis

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.

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.
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
  • Hypotension
  • Tachycardia
Drug: Smoking of cannabis cigarettes (different strength)
Not Provided
Hunault CC, Mensinga TT, Böcker KB, Schipper CM, Kruidenier M, Leenders ME, de Vries I, Meulenbelt J. Cognitive and psychomotor effects in males after smoking a combination of tobacco and cannabis containing up to 69 mg delta-9-tetrahydrocannabinol (THC). Psychopharmacology (Berl). 2009 May;204(1):85-94. Epub 2008 Dec 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
27
December 2005
Not Provided

Inclusion Criteria:

  • Cannabis users (2-9 joints per month)

Exclusion Criteria:

  • Psychiatric illness
  • Evidence of excessive alcohol abuse
  • Use of other drugs
Male
18 Years to 45 Years
Yes
Contact: Tjeert T Mensinga, MD, PhD +31 30 2507340 tjeert.mensinga@rivm.nl
Netherlands
 
NCT00225407
V/267002
Not Provided
Not Provided
UMC Utrecht
Netherlands: Ministry of Health, Welfare and Sports
Principal Investigator: Tjeert T Mensinga, MD, PhD National Institute of Public Health and the Environment, the Netherlands
UMC Utrecht
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP