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Trypt.am is a shortening for the word *tryptamine*.
info (at) entheos (dot) org (dot) nz
To see complete record on www.trialregister.nl, please visit this link
Organisation Name: K.P.C. Kuypers P.O.Box 616 6200 MD Maastricht The Netherlands
Overal Status: Open for patient inclusion
Start Date: 2008-11-01
Lead Sponsor: K.P.C. Kuypers P.O.Box 616 6200 MD Maastricht The Netherlands
Brief Summary: Ecstasy use is commonly linked with memory deficits in abstinent ecstasy users. Similar impairments are being found during ecstasy intoxication after single doses of MDMA. The concordance of memory impairments during intoxication and abstinence suggests a similar neuropharmacological mechanism underlying acute and chronic memory impairments. Cortisol has been implicated in the regulation of memory performance and might play a mediating role in MDMA induced memory impairments as well as MDMA causes an increase in cortisollevels, 1.5 h after intake. It is hypothesized that MDMA induced changes in cortisol levels underlie memory impairments in MDMA users and that the extent of this impairment is positively related to history of MDMA use. To establish the relation between (a) MDMA-induced memory impairment during abstinence and intoxication, and (b) cortisollevels, memory performance of ecstasy users will be assessed under 4 conditions. The study will be conducted according to a double blind, placebo controlled, crossover design with 4 treatment conditions and 2 groups of ecstasy users i.e. 30 novice ecstasy users and 30 heavy ecstasy users. Both groups will comprise an equal number of males and females. It will be a large sample study with 3 different main questions. (1) Role of previous MDMA use on memory function and neuroendocrine function. This will be investigated by comparing memory performance and neuroendocrine functioning of novice and heavy MDMA users during baseline (placebo) conditions. (2) Role of cortisol in MDMA-induced memory impairment. This will be investigated by comparing memory performance during four different treatment conditions (see treatments). It is expected that MDMA-induced memory impairment will be absent after combined treatment with MDMA and Metyrapone, the cortisol synthesis inhibitor, compared with placebo. (3) Role of gender in cortisol responses and memory impairment. This will be investigated by comparing memory performance and neuroendocrine function of males and females after treatment with MDMA compared with placebo.