Processing and Effects of Cannabis - Tabular View

Tracking Information

First Received Date ^ICMJE

September 21, 2005

Last Updated Date

September 21, 2005

Start Date ^ICMJE

July 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Self-reporting questionnaires

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Processing and Effects of Cannabis

Official Title ^ICMJE

A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis

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.

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.

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Pharmacokinetics/Dynamics Study

Condition ^ICMJE

Hypotension
Tachycardia

Intervention ^ICMJE

Drug: Smoking of cannabis cigarettes (different strength)

Study Arms / Comparison Groups

Publications *

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 National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Enrollment ^ICMJE

Completion Date

December 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Cannabis users (2-9 joints per month)

Exclusion Criteria:

Psychiatric illness
Evidence of excessive alcohol abuse
Use of other drugs

Gender

Male

Ages

18 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Tjeert T Mensinga, MD, PhD

+31 30 2507340

tjeert.mensinga@rivm.nl

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT ID ^ICMJE

NCT00225407

Responsible Party

Study ID Numbers ^ICMJE

V/267002

Study Sponsor ^ICMJE

UMC Utrecht

Collaborators ^ICMJE

Netherlands: Ministry of Health, Welfare and Sports

Investigators ^ICMJE

Principal Investigator:

Tjeert T Mensinga, MD, PhD

National Institute of Public Health and the Environment, the Netherlands

Information Provided By

UMC Utrecht

Verification Date

March 2005

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