A study into the safety and effects of psychotherapy in combination with MDMA as a treatment for severe post-traumatic stress disorder

This pending interventional trial (n=0; status unknown), known as M-PSY-PTSD or MDMA4PTSD, will assess the effect of MDMA-assisted psychotherapy on Post-Traumatic Stress Disorder (PTSD).

Led by Kim Kuypers at Maastricht University and sponsored by the Multidisciplinary Association for Psychedelic Studies (MAPS), the study aims to evaluate changes in CAPS-5 Total Severity Score from baseline to 18 weeks post-baseline.

The trial will involve three open-label manualized Experimental Sessions of psychotherapy assisted by flexible doses of MDMA, with doses ranging from 80 mg to 180 mg. The study seeks to provide supportive data on the safety and efficacy of this treatment approach for PTSD. Recruitment is anticipated to start from December 2017.

Original (Dutch) title: Een studie naar de veiligheid en effecten van psychotherapie in combinatie met MDMA als behandeling voor zware post-traumatische stress stoornis

Topic PTSD
Compound Placebo MDMA
Country Netherlands
Visit trial
Status Unknown status
Results Published No
Start date 01 December 2017
End date 30 December 2024
Phase Phase II
Design Blinded
Type Interventional
Generation First
Participants 0
Sex All
Age 18- 99
Therapy Yes

Trial Details

This upcoming trial, M-PSY-PTSD or MDMA4PTSD, led by K.P.C. Kuypers at Maastricht University and sponsored by MAPS, aims to assess the impact of MDMA-assisted psychotherapy on PTSD. It will involve three open-label sessions combining psychotherapy with flexible MDMA doses, ranging from 80 mg to 180 mg. The study seeks to gather supportive data on safety and efficacy for PTSD treatment.

Trial Number NL6483

Sponsors & Collaborators

Maastricht University
Maastricht University is host to the psychopharmacology department (Psychopharmacology in Maastricht) where various researchers are investigating the effects of psychedelics.

MAPS
MAPS stands for Multidisciplinary Association for Psychedelic Studies, it's the front runner in making psychedelics a legal way to use (and improve) in therapy.

Data attribution

A large set of the trials in our database are sourced from ClinicalTrials.gov (CTG). We have modified these post to display the information in a more clear format or to correct spelling mistakes. Our database in actively updated and may show a different status (e.g. completed) if we have knowledge of this update (e.g. a published paper on the study) which isn't reflected yet on CTG. If a trial is not sourced from CTG, this is indicated on this page and you can follow the link to the alternative source of information.