NCT07469098

Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events

An Open-Label, Multicenter, Randomized, Non-Inferiority Study to Evaluate the Safety and Effectiveness of Group vs. Individual MDMA-Assisted Therapy in PTSD Patients Diagnosed Following the Events of October 7, 2023

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 168 (estimated)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the safety, tolerability and effectiveness of group-based MDMA-assisted therapy compared to individual MDMA-assisted therapy in participants with PTSD, who were diagnosed following the events of 7 October 2023. The main questions it aims to answer are: safety and tolerability? effectiveness? Researchers will compare group-based MDMA-assisted therapy to individual MDMA-assisted therapy to see if group-based MDMA-assisted therapy is not inferior to individual MDMA-assisted therapy, in terms of safety and effectiveness. Participants will be randomized to one of two study arms: group-based MDMA-assisted therapy or individual MDMA-assisted therapy receive MDMA HCl administered orally in a divided dose. Participate in preparatory sessions, MDMA dosing sessions, and integration sessions. Be monitored for adverse events and suicidality (C-SSRS). Be monitored by an external Data Safety Monitoring Board (DSMB).

Detailed description

PTSD (post-traumatic stress disorder) is a severe and debilitating disorder that may occur following a traumatic event, with significant consequences on daily life, such as inability to form beneficial relationships, inability to maintain employment, reduced cognitive and psycho-social functioning, depression, anxiety and alcohol disorders and use of addictive substances. Available PTSD treatments include medications and therapy, but they effectively treat only a small portion of people, indicating a need to develop treatments targeting durable remission of PTSD. MDMA is a phenylisopropylamine derivative. MDMA increases levels of serotonin and also increases levels of oxytocin and vasopressin, which are associated with increased trust and reduced reactivity to threatening situations. MDMA is not used as a treatment by itself, but as an adjunct that enhances the effectiveness of psychotherapy. Participants will complete pre-screening. Screening and enrollment procedures include review of medical and psychiatric history, documentation of prior/current medications, and completion of questionnaires. Participants will be asked to complete questionnaires throughout the study, including during screening and at multiple time points across study visits, to assess symptoms and other study-related measures. Eligible participants will be randomized, with allocation managed centrally, to one of two treatment arms. Prior to administration of the investigational product, participants will attend preparatory sessions. MDMA HCl will be administered orally in a divided dose, with a supplemental dose administered 1.5 to 2 hours after the initial dose. During dosing sessions, participants will be monitored, including measurement of vital signs by trained medical staff. Safety procedures include physical examination, urine drug testing, ECG assessment, and safety laboratory tests as specified in the protocol. Safety monitoring will include assessment of adverse events and C-SSRS. Study safety will be overseen by an external Data Safety Monitoring Board (DSMB).

Conditions

• PTSD

Interventions

Type	Name	Description
DRUG	MDMA HCl	MDMA HCl will be administered orally during dosing sessions in a divided dose. In the first dosing session, participants will receive 80 mg MDMA HCl with a supplemental dose of 40 mg administered 1.5 to 2 hours after the initial dose. In the second and third dosing sessions, participants will receive 120 mg MDMA HCl with a supplemental dose of 60 mg administered 1.5 to 2 hours after the initial dose.

Timeline

• Start date: 2025-12-24
• Primary completion: 2028-12-31
• Completion: 2029-03-31
• First posted: 2026-03-13
• Last updated: 2026-03-13

Locations

2 sites across 1 country: Israel