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Mdma Clinical Trials

Effects of MDMA on memory when witnessing or committing a simulated crime

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Id: NTR7665

Organisation Name: Maastricht University

Overal Status: Open for patient inclusion

Start Date: 2017-11-01

Lead Sponsor: Maastricht University

Brief Summary: Rationale: Legal cases have shown that eyewitnesses and innocent suspects can falsely remember to have seen non-existing details of a crime or falsely confess to have committed a crime due to suggestive interrogation tactics of the police. Eyewitnesses and suspects are often under the influence of the party-drug ecstasy (MDMA) but little knowledge exists whether their drugged state makes them more vulnerable to spontaneous or suggestion-induced false memories.
Objective: Objectives of this study are twofold. The current project will examine the impact of MDMA intoxication on susceptibility to false memories and dissociation. Additionally, the effect of MDMA on functional connectivity between the striatum and the prefrontal cortex will be studied using fMRI in a subset of participants.

Study design: Acute and delayed influences of MDMA on false memory formation will be assessed in a placebo-controlled study in occasional MDMA users, using a virtual reality (VR) eyewitness and a perpetrator scenario. The order of treatments and scenarios will be counterbalanced across participants.

Study population: Sixty-four healthy, occasional MDMA users, aged 18-40.

Intervention (if applicable): Placebo and MDMA (75mg)
Main study parameters/endpoints: Spontaneous and suggestion-based false memories will be assessed by using established false memory paradigms (associatively-related word lists, mock crime). Dissociative states and traits will be assessed using both established self-report and clinician-administered measures. Functional connectivity will be assessed using resting state fMRI.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Participants will visit our lab five times. The first visit includes a full medical screening by a licensed physician ensuring their safety, which will include a medical history review, a blood sample (12 ml), and an electrocardiogram recording. The second includes a short training session to familiarize them with the testing procedures and (potentially) the MRI scanner. During the third and fourth visit, participants will be administered placebo and MDMA (capsule) and be exposed to two distinct mock crime Virtual Reality (VR) scenarios on two separate occasions, each followed by an immediate and a one-week follow-up assessment, including measures of true and false memory and dissociative states and traits. Moreover, a subset of 12 participants will undergo a resting state functional connectivity assessment inside the magnetic resonance scanner (time in MRI scanner is ~20 minutes). Finally, participants will return a week later for a brief follow up visit (20 minutes) in which they will receive follow-up false memory tests.

Country: Netherlands

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