NCT00235768

Brief Summary

The purpose of this study is to investigate the possible neurotoxic effects of the party-drug Ecstasy (MDMA)on brain and brain function in humans. Main research questions concern the causality, course and clinical relevance of the neurotoxicity of ecstasy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
225

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2002

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

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

April 1, 2002

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 10, 2005

Completed
Last Updated

October 10, 2005

Status Verified

October 1, 2004

First QC Date

October 6, 2005

Last Update Submit

October 6, 2005

Conditions

Ecstasy (Drug)N-Methyl-3,4-MethylenedioxymethamphetaminePsychopathology

Keywords

EcstasyMDMACognitionBrain functionNeuroimaging

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • between 18 - 35 years of age

You may not qualify if:

  • severe medical or neuropsychiatric illness
  • use of prescribed psychotropic medications such as SSRI's
  • use of intravenous drugs
  • pregnancy
  • contra-indications for MRI investigation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Bonger Institute of Criminology

Amsterdam, North Holland, 1000 BA, Netherlands

Location

Academic Medical Center Amsterdam

Amsterdam, North Holland, 1100 DD, Netherlands

Location

University Medical Center Utrecht

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (7)

  • de Win MM, de Jeu RA, de Bruin K, Habraken JB, Reneman L, Booij J, den Heeten GJ. Validity of in vivo [123I]beta-CIT SPECT in detecting MDMA-induced neurotoxicity in rats. Eur Neuropsychopharmacol. 2004 May;14(3):185-9. doi: 10.1016/S0924-977X(03)00101-9.

    PMID: 15056477BACKGROUND

  • de Win MM, Reneman L, Reitsma JB, den Heeten GJ, Booij J, van den Brink W. Mood disorders and serotonin transporter density in ecstasy users--the influence of long-term abstention, dose, and gender. Psychopharmacology (Berl). 2004 May;173(3-4):376-82. doi: 10.1007/s00213-003-1723-4. Epub 2004 Jan 15.

    PMID: 14726997BACKGROUND

  • Reneman L, Booij J, Majoie CB, Van Den Brink W, Den Heeten GJ. Investigating the potential neurotoxicity of Ecstasy (MDMA): an imaging approach. Hum Psychopharmacol. 2001 Dec;16(8):579-588. doi: 10.1002/hup.347.

    PMID: 12404537BACKGROUND

  • Reneman L, Endert E, de Bruin K, Lavalaye J, Feenstra MG, de Wolff FA, Booij J. The acute and chronic effects of MDMA ("ecstasy") on cortical 5-HT2A receptors in rat and human brain. Neuropsychopharmacology. 2002 Mar;26(3):387-96. doi: 10.1016/S0893-133X(01)00366-9.

    PMID: 11850153BACKGROUND

  • Reneman L, Booij J, de Bruin K, Reitsma JB, de Wolff FA, Gunning WB, den Heeten GJ, van den Brink W. Effects of dose, sex, and long-term abstention from use on toxic effects of MDMA (ecstasy) on brain serotonin neurons. Lancet. 2001 Dec 1;358(9296):1864-9. doi: 10.1016/S0140-6736(01)06888-X.

    PMID: 11741626BACKGROUND

  • Reneman L, Majoie CB, Habraken JB, den Heeten GJ. Effects of ecstasy (MDMA) on the brain in abstinent users: initial observations with diffusion and perfusion MR imaging. Radiology. 2001 Sep;220(3):611-7. doi: 10.1148/radiol.2202001602.

    PMID: 11526257BACKGROUND

  • De Win MM, Jager G, Vervaeke HK, Schilt T, Reneman L, Booij J, Verhulst FC, Den Heeten GJ, Ramsey NF, Korf DJ, Van den Brink W. The Netherlands XTC Toxicity (NeXT) study: objectives and methods of a study investigating causality, course, and clinical relevance. Int J Methods Psychiatr Res. 2005;14(4):167-85. doi: 10.1002/mpr.6.

    PMID: 16395871RESULT

Study Officials

  • Wim van den Brink, MD PhD

    University of Amsterdam, Academic Medical Center Amsterdam, Dep of Psychiatry

    STUDY DIRECTOR

  • Nick F Ramsey, PhD

    University Medical Center Utrecht, Dep of Psychiatry

    STUDY DIRECTOR

  • Dirk J Korf, PhD

    University of Amsterdam, Bonger Institute for Criminology

    STUDY DIRECTOR

  • Maartje ML de Win, MD

    University of Amsterdam, Academic Medical Center Amsterdam, Dep of Radiology

    PRINCIPAL INVESTIGATOR

  • Gerry Jager, MSc

    University Medical Center Utrecht, Dep of Psychiatry

    PRINCIPAL INVESTIGATOR

  • Hylke KE Vervaeke, MSc

    University of Amsterdam, Bonger Institute of Criminology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
DEFINED POPULATION
Time Perspective
OTHER
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 6, 2005

First Posted

October 10, 2005

Study Start

April 1, 2002

Study Completion

July 1, 2005

Last Updated

October 10, 2005

Record last verified: 2004-10

Locations

NL(3)