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Mdma Clinical Trials

Een studie naar de veiligheid en effecten van psychotherapie in combinatie met MDMA als behandeling voor zware post-traumatische stress stoornis

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Id: NTR6670

Organisation Name: K.P.C. Kuypers, Maastricht University

Overal Status: Planned

Start Date: 2017-12-01

Lead Sponsor: K.P.C. Kuypers, Maastricht University

Brief Summary: Post-traumatic stress disorder is a very debilitating disease, impairing the quality of life of people suffering from it. Current treatments are not effective in a large number of cases, pressing the need for alternative treatments . MDMA has been shown to reduce defenses and fear of emotional injury, enhance communication, and increase empathy, and it may enhance fear extinction learning in humans. These subjective effects of MDMA create a productive psychological state that enhances the therapeutic process for the treatment of PTSD and other anxiety disorders. This novel treatment package consists of three once-monthly Experimental Sessions of psychotherapy combined with a flexible dose of MDMA, along with non-drug preparatory and integrative psychotherapy. This is supported by data from an international series of Phase 2 pilot studies of MDMA-assisted psychotherapy conducted by MAPS, the sponsor, providing preliminary evidence that chronic PTSD, independent of cause, is treatable with two to three sessions of MDMA-assisted psychotherapy and associated non-drug preparatory and integrative psychotherapy. The results from multiple independent studies in Phase 2 efficacy analyses demonstrate superiority of MDMA-assisted psychotherapy over psychotherapy with placebo or low dose MDMA. The acceptable risk-benefit ratio in early trials justifies further study.

This open-label lead-in Phase 2 study is intended to gather supportive data on the safety and effect of manualized MDMA-assisted psychotherapy as a treatment for PTSD. The Primary Outcome measure, the change in Clinician Administered PTSD Scale for DSM-5 (CAPS-5) from Baseline, evaluates changes in PTSD symptom severity and is assessed by a centralized Independent Rater (IR) pool in this study and in planned Phase 3 clinical trials. This study will gather supportive data on the safety and effect of manualized MDMA-assisted psychotherapy as a treatment for PTSD and provide clinical supervision to planned Phase 3 therapy teams. This study will explore reproducibility of findings gathered at another research site to further confirm the Phase 3 study design.

In this Phase 2 study, a therapy team without previous experience on a MAPS-sponsored MDMA-assisted psychotherapy study will have the opportunity for clinical supervision from the sponsor prior to their roles in Phase 3 studies. Only sites planned for Phase 3 will participate in this study. The sponsor conducts group and individual training programs to teach therapy team members about techniques and procedures for conducting MDMA-assisted psychotherapy for PTSD. These programs are designed to support and expand the knowledge and skills of therapy team members who will be working on MDMA research studies.

Country: Netherlands

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