Back to results

Processing and Effects of Cannabis

Primary Purpose

Hypotension, Tachycardia

Status

Unknown status

Phase

Phase 1

Locations

Netherlands

Study Type

Interventional

Intervention

Smoking of cannabis cigarettes (different strength)

About this trial

This is an interventional prevention trial for Hypotension focused on measuring Cannabis, Tetrahydrocannabinol, Pharmacokinetics, Psychomotor tests, Event related potentials

Eligibility Criteria

18 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria: Cannabis users (2-9 joints per month) Exclusion Criteria: Psychiatric illness Evidence of excessive alcohol abuse Use of other drugs

Sites / Locations

University Medical Center UtrechtRecruiting

Outcomes

Primary Outcome Measures

Serum concentration over time

Physical parameters (heart rate, blood pressure)

Psychomotor tests (such continuous attention)

Event related potentials

Secondary Outcome Measures

Self-reporting questionnaires

Full Information

NCT ID

NCT00225407

First Posted

September 21, 2005

Last Updated

September 21, 2005

Sponsor

UMC Utrecht

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

1. Study Identification

Unique Protocol Identification Number

NCT00225407

Brief Title

Processing and Effects of Cannabis

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2005

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

UMC Utrecht

Collaborators

Netherlands: Ministry of Health, Welfare and Sports

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypotension, Tachycardia

Keywords

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

Double

Allocation

Randomized

Enrollment

27 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Smoking of cannabis cigarettes (different strength)

Primary Outcome Measure Information:

Title

Serum concentration over time

Title

Physical parameters (heart rate, blood pressure)

Title

Psychomotor tests (such continuous attention)

Title

Event related potentials

Secondary Outcome Measure Information:

Title

Self-reporting questionnaires

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Cannabis users (2-9 joints per month) Exclusion Criteria: Psychiatric illness Evidence of excessive alcohol abuse Use of other drugs

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tjeert T Mensinga, MD, PhD

Phone

+31 30 2507340

tjeert.mensinga@rivm.nl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tjeert T Mensinga, MD, PhD

Organizational Affiliation

National Institute of Public Health and the Environment, the Netherlands

Official's Role

Principal Investigator

Facility Information:

Facility Name

University Medical Center Utrecht

City

Utrecht

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tjeert T Mensinga, MD, PhD

Phone

+31 30 2507340

tjeert.mensinga@rivm.nl

First Name & Middle Initial & Last Name & Degree

Tjeert T Mensinga, MD, PhD

12. IPD Sharing Statement

Citations:

PubMed Identifier

19099294

Citation

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.

Results Reference

derived

Learn more about this trial

Processing and Effects of Cannabis

We'll reach out to this number within 24 hrs