Processing and Effects of Cannabis - Full Text View

Sponsor:	UMC Utrecht
Collaborator:	Netherlands: Ministry of Health, Welfare and Sports
Information provided by:	UMC Utrecht
ClinicalTrials.gov Identifier:	NCT00225407

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 I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study
Official Title:	A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis

Resource links provided by NLM:

Genetics Home Reference related topics: Brugada syndrome short QT syndrome

MedlinePlus related topics: Low Blood Pressure

Drug Information available for: GW-1000 Cannabis

U.S. FDA Resources

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

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 National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	V/267002
Study First Received:	September 21, 2005
Last Updated:	September 21, 2005
ClinicalTrials.gov Identifier:	NCT00225407 History of Changes
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
Pathologic Processes
Heart Diseases
Tachycardia

Vascular Diseases
Cardiovascular Diseases
Arrhythmias, Cardiac

ClinicalTrials.gov processed this record on November 27, 2009