Processing and Effects of Cannabis | NCT00225407

Studies
Processing and Effects of Cannabis

NCT00225407

Sponsor

UMC Utrecht

Status

Unknown status

Last Update Posted

Sep 23, 2005Estimated

Enrollment

Phase

Phase 1

Conditions

Hypotension
Tachycardia

Interventions

Smoking of cannabis cigarettes (different strength)

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Dec 2005

First Submitted Date

Sep 21, 2005

First Submission Date that Met QC Criteria

Sep 21, 2005

First Posted Date

Sep 23, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 21, 2005

Last Update Posted Date

Sep 23, 2005Estimated

Name	Class
Netherlands: Ministry of Health, Welfare and Sports	OTHER_GOV

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Smoking of cannabis cigarettes (different strength)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Serum concentration over time
Physical parameters (heart rate, blood pressure)
Psychomotor tests (such continuous attention)
Event related potentials

Secondary Outcomes

Measure	Description	Time Frame
Self-reporting questionnaires

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Cannabis users (2-9 joints per month)

Exclusion Criteria:

Psychiatric illness
Evidence of excessive alcohol abuse
Use of other drugs

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Tjeert T Mensinga, MD, PhD	Contact	+31 30 2507340		tjeert.mensinga@rivm.nl

Overall Officials

Name	Affiliation	Role
Tjeert T Mensinga, MD, PhD	National Institute of Public Health and the Environment, the Netherlands	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Medical Center Utrecht	Recruiting	Utrecht			Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19099294	Derived	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.

ID	Term
D007022	Hypotension
D013610	Tachycardia
D002189	Marijuana Abuse

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases