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
  Purpose

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 Intervention Phase
Hypotension
Tachycardia
Drug: Smoking of cannabis cigarettes (different strength)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

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

Secondary Outcome Measures:
  • Self-reporting questionnaires

Estimated Enrollment: 27
Study Start Date: July 2005
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Cannabis users (2-9 joints per month)

Exclusion Criteria:

  • Psychiatric illness
  • Evidence of excessive alcohol abuse
  • Use of other drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225407

Contacts
Contact: Tjeert T Mensinga, MD, PhD +31 30 2507340 tjeert.mensinga@rivm.nl

Locations
Netherlands
University Medical Center Utrecht Recruiting
Utrecht, Netherlands
Contact: Tjeert T Mensinga, MD, PhD    +31 30 2507340    tjeert.mensinga@rivm.nl   
Principal Investigator: Tjeert T Mensinga, MD, PhD         
Sponsors and Collaborators
UMC Utrecht
Netherlands: Ministry of Health, Welfare and Sports
Investigators
Principal Investigator: Tjeert T Mensinga, MD, PhD National Institute of Public Health and the Environment, the Netherlands
  More Information

No publications provided by UMC Utrecht

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00225407     History of Changes
Other Study ID Numbers: V/267002
Study First Received: September 21, 2005
Last Updated: September 21, 2005
Health Authority: National Institute of Public Health and the Environment, the Netherlands:

Keywords provided by UMC Utrecht:
Cannabis
Tetrahydrocannabinol
Pharmacokinetics
Psychomotor tests
Event related potentials

Additional relevant MeSH terms:
Hypotension
Tachycardia
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014