Processing and Effects of Cannabis

NCT ID: NCT00225407

Last Updated: 2005-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-07-31

Study Completion Date

2005-12-31

Brief Summary

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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

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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.

Conditions

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Hypotension Tachycardia

Keywords

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Cannabis Tetrahydrocannabinol Pharmacokinetics Psychomotor tests Event related potentials

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Smoking of cannabis cigarettes (different strength)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Cannabis users (2-9 joints per month)

Exclusion Criteria

* Psychiatric illness
* Evidence of excessive alcohol abuse
* Use of other drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Netherlands: Ministry of Health, Welfare and Sports

OTHER_GOV

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Principal Investigators

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Tjeert T Mensinga, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

National Institute of Public Health and the Environment, the Netherlands

Locations

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University Medical Center Utrecht

Utrecht, , Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Tjeert T Mensinga, MD, PhD

Role: CONTACT

Phone: +31 30 2507340

Email: [email protected]

Facility Contacts

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Tjeert T Mensinga, MD, PhD

Role: primary

References

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Hunault CC, Mensinga TT, Bocker 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. doi: 10.1007/s00213-008-1440-0. Epub 2008 Dec 20.

Reference Type DERIVED
PMID: 19099294 (View on PubMed)

Other Identifiers

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V/267002

Identifier Type: -

Identifier Source: org_study_id