Processing and Effects of Cannabis
Recruitment status was Recruiting
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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 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacokinetics/Dynamics Study Intervention Model: Crossover Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis |
- Serum concentration over time
- Physical parameters (heart rate, blood pressure)
- Psychomotor tests (such continuous attention)
- Event related potentials
- Self-reporting questionnaires
| Estimated Enrollment: | 27 |
| Study Start Date: | July 2005 |
| Estimated Study Completion Date: | December 2005 |
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 |
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| Contact: Tjeert T Mensinga, MD, PhD | +31 30 2507340 | tjeert.mensinga@rivm.nl |
| 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 | |
| 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 ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00225407 History of Changes |
| Other Study ID Numbers: | V/267002 |
| Study First Received: | September 21, 2005 |
| Last Updated: | September 21, 2005 |
| 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 Tachycardia Vascular Diseases Cardiovascular Diseases |
Arrhythmias, Cardiac Heart Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013