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Study of Feasibility and Safety of MDMA-Assisted Group Therapy for the Treatment of PTSD in Veterans — MPG1  

PTSD Clinical Trial

Official title:
An Open-Label Feasibility and Safety Study of MDMA-Assisted Group Therapy for the Treatment of Posttraumatic Stress Disorder in Veterans

Clinical Trial Summary

This Phase 2, open-label, non-randomized, 3-cohort study assesses the feasibility and safety of MDMA-assisted group therapy for the treatment of PTSD in veterans. The study will be conducted in up to N=18 participants, recruited in three cohorts of six participants and receive therapy sessions throughout their participation in these groups.

Clinical Trial Description

To further assess the feasibility and safety of MDMA-assisted group therapy for participants with at least moderate PTSD, the sponsor is conducting a phase 2, open-label, non-randomized, 3-cohort study. This novel treatment package consists of two once-monthly Experimental Sessions of therapy combined with a divided-dose of MDMA, along with non-drug preparatory and integrative therapy administered in both individual and group sessions. The Primary Outcome measure, the Clinician Administered PTSD Scale (CAPS-5), evaluates changes in PTSD symptom severity and is assessed by a blinded centralized Independent Rater (IR) pool. The therapeutic approach will combine manualized MDMA-assisted therapy for PTSD with group therapy components. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05173831
Study type Interventional
Source Lykos Therapeutics
Contact
Status Withdrawn
Phase Phase 2
Start date September 2023
Completion date December 2024
View Details
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