Clinical TrialNeuroimaging & Brain MeasuresCompleted
The NeXT Study
This naturalistic observational study (n=225) investigates possible neurotoxic effects of recreational MDMA (ecstasy) on the human brain using imaging and cognitive measures.
Target Enrollment
225 participants
Study Type
Phase NA observational
Design
Non-randomized
Registry
Detailed Description
Prospective and retrospective components assess causality, course and clinical relevance of MDMA-related neurotoxicity. Cohorts include high-risk MDMA-naïve individuals followed for incident use, retrospectively selected exposed/unexposed participants, and a cross-sectional group with varied drug histories.
Outcomes include neuroimaging (SPECT, 1H-MRS, fMRI, perfusion MRI) and clinical measures of memory, mood and personality, controlling for confounders.
Participants
Ages
18 – 35
Sexes
Male & Female
BMI
-
Psychosis History
-
Inclusion Criteria
- Inclusion Criteria:
- between 18 - 35 years of age
Exclusion Criteria
- 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
Study Details
- StatusCompleted
- PhasePhase NA
- Typeobservational
- DesignNon-randomized
- Target Enrollment225 participants
- TimelineStart: 2002-04-01End: 2005-07-01
- Topic
Locations
Bonger Institute of Criminology — Amsterdam, North Holland, Netherlands
Academic Medical Center Amsterdam — Amsterdam, North Holland, Netherlands
University Medical Center Utrecht — Utrecht, Utrecht, Netherlands