Processing and Effects of Cannabis

Condition(s) targeted: Hypotension; Tachycardia

Intervention: Smoking of cannabis cigarettes (different strength) (Drug)

Phase: Phase 1

Status: Recruiting

Sponsored by: UMC Utrecht

Official(s) and/or principal investigator(s):
Tjeert T Mensinga, MD, PhD, Principal Investigator, Affiliation: National Institute of Public Health and the Environment, the Netherlands

Overall contact:
Tjeert T Mensinga, MD, PhD, Phone: +31 30 2507340, Email: tjeert.mensinga@rivm.nl

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.

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

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

Primary outcome:

Serum concentration over time

Physical parameters (heart rate, blood pressure)

Psychomotor tests (such continuous attention)

Event related potentials

Secondary outcome: Self-reporting questionnaires

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.

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Male.

Criteria:

Inclusion Criteria:

- Cannabis users (2-9 joints per month)

Exclusion Criteria:

- Psychiatric illness

- Evidence of excessive alcohol abuse

- Use of other drugs

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

University Medical Center Utrecht, Utrecht, Netherlands; Recruiting
Tjeert T Mensinga, MD, PhD, Phone: +31 30 2507340, Email: tjeert.mensinga@rivm.nl
Tjeert T Mensinga, MD, PhD, Principal Investigator

Starting date: July 2005
Ending date: December 2005
Last updated: September 21, 2005