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Processing and Effects of Cannabis

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00225407
Enrollment
27
Registered
2005-09-23
Start date
2005-07-31
Completion date
2005-12-31
Last updated
2005-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypotension, Tachycardia

Keywords

Cannabis, Tetrahydrocannabinol, Pharmacokinetics, Psychomotor tests, Event related potentials

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.

Interventions

DRUGSmoking of cannabis cigarettes (different strength)

Sponsors

Netherlands: Ministry of Health, Welfare and Sports
CollaboratorOTHER_GOV
UMC Utrecht
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
MALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

* Cannabis users (2-9 joints per month)

Exclusion criteria

* Psychiatric illness * Evidence of excessive alcohol abuse * Use of other drugs

Design outcomes

Primary

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

Secondary

MeasureTime frame
Self-reporting questionnaires

Countries

Netherlands

Contacts

Primary ContactTjeert T Mensinga, MD, PhD
tjeert.mensinga@rivm.nl+31 30 2507340

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026