NCT00225407

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Jul 2005

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
Last Updated

September 23, 2005

Status Verified

March 1, 2005

First QC Date

September 21, 2005

Last Update Submit

September 21, 2005

Conditions

HypotensionTachycardia

Keywords

CannabisTetrahydrocannabinolPharmacokineticsPsychomotor testsEvent related potentials

Outcome Measures

Primary Outcomes (4)

  • Serum concentration over time

  • Physical parameters (heart rate, blood pressure)

  • Psychomotor tests (such continuous attention)

  • Event related potentials

Secondary Outcomes (1)

  • Self-reporting questionnaires

Interventions

Smoking of cannabis cigarettes (different strength)DRUG

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Cannabis users (2-9 joints per month)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Center Utrecht

Utrecht, Netherlands

RECRUITING

Related Publications (1)

  • 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.

    PMID: 19099294DERIVED

MeSH Terms

Conditions

HypotensionTachycardiaMarijuana Abuse

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesArrhythmias, CardiacHeart DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Tjeert T Mensinga, MD, PhD

    National Institute of Public Health and the Environment, the Netherlands

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tjeert T Mensinga, MD, PhD

CONTACT

+31 30 2507340tjeert.mensinga@rivm.nl

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 21, 2005

First Posted

September 23, 2005

Study Start

July 1, 2005

Study Completion

December 1, 2005

Last Updated

September 23, 2005

Record last verified: 2005-03

Locations

NL(1)