The NeXT Study; The Netherlands XTC Toxicity Study

This study has been completed.
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University of Amsterdam
Erasmus Medical Center
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00235768
First received: October 6, 2005
Last updated: NA
Last verified: October 2004
History: No changes posted
  Purpose

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


Condition Phase
Ecstasy (Drug)
N-Methyl-3,4-Methylenedioxymethamphetamine
Psychopathology
Phase 1

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Neurotoxicity of Ecstasy: Causality, Course and Clinical Relevance

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Estimated Enrollment: 225
Study Start Date: April 2002
Estimated Study Completion Date: July 2005
Detailed Description:

The study aims to investigate the causality, course and clinical relevance of the observed neurotoxicity in het human brain among users of the popular recreational drug 3,4-methylenedioxymethamphetamine (MDMA). Studies in animals and non-human primates suggest that MDMA is toxic toward brain serotonin neurons at doses that overlap those used by humans. Much less is known about the effects of this drug on the human brain. Recent studies, however, suggest that MDMA might also be neurotoxic to 5-HT neurons in humans, and that it is associated with functional consequences, such as memory impairment and depression. However, these studies have been retrospective and potentially vulnerable to selection bias and confounding. Clearly, only a prospective study can ascertain that recreational XTC is neurotoxic in humans. However, given the existing data such a study is ethically not acceptable. In the present project, therefore, we have chosen a naturalistic study using a combination of prospective and retrospective approaches: a prospective study among 200 XTC naive subjects with a high-risk profile for first XTC use with a two-year follow up of 50 incident-, and 50 continuously XTC naive subjects, and a retrospective design of 25 subjects with and 25 subjects without prior exposure to XTC selected from a large representative cohort (N=1600) that was prospectively followed from the age of 12. In addition, a cross sectional design is used of 70 subjects with variation in type and amount of drugs used, besides a history of frequent XTC use. Among the 50 incident cases and the sample of 50 continuously XTC-naive subjects in the prospective cohort, indicators of neurotoxicity (SPECT,1H-MRS), markers of neuronal injury (fMRI, Perfusion MRI), and clinical assessments of memory, mood and personality prior to any XTC use will be compared with the same parameters two years later, i.e. after XTC user has taken place in the incident cases. In the retrospective cohort, subjects with lifetime XTC exposure will be compared with XTC naive subjects on the same neurotoxicity, neural injury and psychopathology parameters, controlling for potential confounders that were assessed prior to the first use of XTC. In the cross sectional cohort, all subjects will be assessed on the same neurotoxicity, neural injury and psychopathology parameters, controlling for the confounding effects of the use of other psychoactive drugs besides XTC. The combined results will result in conclusions that can be validly used in prevention messages, clinical decision making and the development op a national XTC policy.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • between 18 - 35 years of age

Exclusion Criteria:

  • severe medical or neuropsychiatric illness
  • use of prescribed psychotropic medications such as SSRI's
  • use of intravenous drugs
  • pregnancy
  • contra-indications for MRI investigation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00235768

Locations
Netherlands
Academic Medical Center Amsterdam
Amsterdam, NH, Netherlands, 1100 DD
Bonger Institute of Criminology
Amsterdam, NH, Netherlands, 1000 BA
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
VU University of Amsterdam
Erasmus Medical Center
Investigators
Study Director: 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
Principal Investigator: 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 VU University of Amsterdam
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00235768     History of Changes
Other Study ID Numbers: ZonMW 310-00-036
Study First Received: October 6, 2005
Last Updated: October 6, 2005
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by UMC Utrecht:
Ecstasy
MDMA
Cognition
Brain function
Neuroimaging

ClinicalTrials.gov processed this record on October 19, 2014