Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05732155
PHASE2

Preliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD

Sponsor: Guy Schusheim

View on ClinicalTrials.gov

Summary

The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol. The overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2023-06-01

Completion Date

2028-07-01

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DRUG

methylenedioxymethamphetamine

Participants in the experimental arm receive MDMA hydrochloride during three approximately 8-hour experimental sessions conducted within a manualized MDMA-assisted therapy protocol. Two sessions are delivered individually and one is delivered in a group setting. Each session includes an initial dose of MDMA hydrochloride followed by a planned supplemental half-dose approximately two hours later, unless the participant declines or tolerability concerns arise. MDMA administration is embedded within preparatory and integration psychotherapy delivered according to the study protocol.

Locations (1)

Emek medical center

Afula, Israel