Processing and Effects of Cannabis

Hypotension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00225407
• Other study ID #: V/267002
• Status: Recruiting
• Phase: Phase 1
• First received: September 21, 2005
• Last updated: September 21, 2005
• Start date: July 2005
• Est. completion date: December 2005

Study information

• Verified date: March 2005
• Source: UMC Utrecht
• Contact: Tjeert T Mensinga, MD, PhD
• Phone: +31 30 2507340
• Email: tjeert.mensinga[@]rivm.nl
• Is FDA regulated: No
• Health authority: National Institute of Public Health and the Environment, the Netherlands:
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 27
• Est. completion date: December 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Cannabis users (2-9 joints per month)

Exclusion Criteria:

• Psychiatric illness

• Evidence of excessive alcohol abuse

• Use of other drugs

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypotension
• Tachycardia

Intervention

Drug:
• Smoking of cannabis cigarettes (different strength)

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	Netherlands: Ministry of Health, Welfare and Sports

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum concentration over time
Primary	Physical parameters (heart rate, blood pressure)
Primary	Psychomotor tests (such continuous attention)
Primary	Event related potentials
Secondary	Self-reporting questionnaires