RecruitingPhase 2

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

Israel168 participantsStarted 2025-12-24

Plain-language 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).

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Are at least 18 years old.
✓. At Screening, meet DSM-5 criteria for current PTSD that has been diagnosed past 7/10/23 and the events following.
✓. At Screening, have at least moderate PTSD symptoms in the last month, based on PCL-5 total score of 36 or greater, conducted by certified Study coordinators.
✓. Are fluent in speaking and reading the predominantly used or recognized language of the study site (Hebrew).
✓. Are able to swallow pills.
✓. Participant where in psychotherapy prior to the study. If the participant is still in psychotherapy during study enrollment, they consent to continue therapy during the study and provide consent for the investigator to communicate with the therapist as needed.
✓. Must provide a contact (relative, spouse, close friend, or other support person) who is willing and able to be reached by the investigators in the event of a participant becoming suicidal or unreachable.
✓. Must agree to inform the investigators within 48 hours of any medical conditions and procedures.

Exclusion criteria

What they're measuring

Change in PTSD symptoms as measured by CAPS-5

Timeframe: Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)

Change in PTSD symptoms as measured by PCL-5

Timeframe: Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)

Trial details

NCT IDNCT07469098

SponsorSheba Medical Center

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2028-12-31

Contact for this trial

Revital Amiaz

972542378757 revital.amiaz@sheba.health.gov.il

View on ClinicalTrials.gov More PTSD trials