Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The NeXT Study; The Netherlands XTC Toxicity Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00235768
Recruitment Status : Completed
First Posted : October 10, 2005
Last Update Posted : October 10, 2005
Sponsor:
Collaborators:
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
University of Amsterdam, Bonger Institute of Criminology
Erasmus Medical Center
Information provided by:
UMC Utrecht

Tracking Information
First Submitted Date October 6, 2005
First Posted Date October 10, 2005
Last Update Posted Date October 10, 2005
Study Start Date April 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The NeXT Study; The Netherlands XTC Toxicity Study
Official Title Neurotoxicity of Ecstasy: Causality, Course and Clinical Relevance
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
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.
Study Type Observational
Study Design Observational Model: Defined Population
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Not Provided
Study Population Not Provided
Condition
  • Ecstasy (Drug)
  • N-Methyl-3,4-Methylenedioxymethamphetamine
  • Psychopathology
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Enrollment
 (submitted: October¬†6,¬†2005)
225
Original Enrollment Same as current
Study Completion Date July 2005
Primary Completion Date Not Provided
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 35 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number NCT00235768
Other Study ID Numbers ZonMW 310-00-036
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Not Provided
Original Responsible Party Same as current
Current Study Sponsor UMC Utrecht
Original Study Sponsor Same as current
Collaborators
  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
  • University of Amsterdam, Bonger Institute of Criminology
  • 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 University of Amsterdam, Bonger Institute of Criminology
PRS Account UMC Utrecht
Verification Date October 2004