Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00235768
Status:
COMPLETED
Last Update Posted:
2005-10-10
First Post:
2005-10-06
Brief Title:
The NeXT Study The Netherlands XTC Toxicity Study
Sponsor:
UMC Utrecht
Organization:
UMC Utrecht
Study Overview
Official Title:
Neurotoxicity of Ecstasy Causality Course and Clinical Relevance
Status:
COMPLETED
Status Verified Date:
2004-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to investigate the possible neurotoxic effects of the party-drug Ecstasy MDMAon 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 34-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 N1600 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 SPECT1H-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 ie 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None