Clinical Trials
Recruiting Phase 2 Trial Compares Group and Individual MDMA-Assisted Therapy for PTSD After October 7
2026-03-31 ยท 5 min read
Registry status - verified September 1, 2026: NCT07469098 is recruiting. It has no posted results. The information below describes the registered study design and planned measurements, not evidence that either approach is effective, equivalent, safer, or more scalable.
What the study is designed to compare
The official study title describes NCT07469098 as an open-label, multicenter, randomized, non-inferiority study comparing group and individual MDMA-assisted therapy in people diagnosed with post-traumatic stress disorder after the events of October 7, 2023.
ClinicalTrials.gov lists the interventional study as phase 2, with a parallel assignment and no masking. Its registered purpose is to evaluate safety, tolerability, and effectiveness and to test whether the group-based approach is not inferior to the individual approach under the study protocol. Non-inferiority is the question being tested; it is not a result.
The lead sponsor is Sheba Medical Center. The registry reports an actual study start date of December 24, 2025, estimated primary completion on December 31, 2028, and estimated study completion on March 31, 2029. Those future dates are estimates and may change when the record is updated.
Random assignment, not participant choice
The registry says an estimated 168 participants will be randomized in a 1:3 ratio between individual and group-based MDMA-assisted therapy. Allocation is managed centrally. The registered design therefore does not support saying that participants can choose their preferred format.
The group arm may include up to seven participants per group, with participants grouped by the same type of trauma. Both arms use MDMA hydrochloride administered orally in divided doses and include preparatory, dosing, and integration sessions according to the protocol.
These descriptions identify the study procedures. They do not establish that one format is preferable for a particular participant.
Planned outcomes and safety monitoring
The registered primary outcomes are changes from baseline in PTSD symptoms measured with the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) and the PTSD Checklist for DSM-5 (PCL-5) at each arm's end-of-treatment visit.
Registered secondary outcomes include adverse events, treatment-emergent adverse events, adverse events of special interest, serious adverse events, suicidal ideation and behavior, and changes in blood pressure, heart rate, respiratory rate, and body temperature. The record also describes external Data Safety Monitoring Board oversight.
These are planned outcome and monitoring measures. ClinicalTrials.gov currently reports no results posted, so the registry does not yet provide comparative efficacy, safety, tolerability, or non-inferiority findings.
What cannot be concluded from this registration
The existence and design of NCT07469098 do not show that group MDMA-assisted therapy works as well as individual therapy. They also do not show that either format is effective or safe for people outside the trial.
The group format may raise research questions about how care could be delivered, but this record does not report staffing requirements, cost savings, clinician capacity, broader access, or scalability outcomes. Claims that the group format will reduce costs, require fewer clinicians, or expand access would go beyond the posted registry information.
Likewise, randomization means the study is not offering a simple participant choice between group and individual treatment. Eligibility, enrollment, allocation, and participation are governed by the study protocol and site procedures.
Bottom line
NCT07469098 is a recruiting phase 2 trial with an estimated enrollment of 168 and estimated completion in March 2029. Its randomized, open-label non-inferiority design is intended to compare group and individual MDMA-assisted therapy after October 7-related PTSD. Until results are posted, the record supports describing the research question and protocol only - not claiming efficacy, comparative benefit, participant choice, or scalability.
Registry record and API data verified September 1, 2026 on ClinicalTrials.gov. The record's last update was posted March 13, 2026.