Group vs Individual MDMA-Assisted Therapy for PTSD After the October 7, 2023 Events
ConditionPTSD
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSheba Medical Center
About this trial
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).
Eligibility criteria
Qualifiers
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).
Disqualifiers
Are not able to give adequate informed consent.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or study clinician, contraindicates participation in the study.
Active military duty expected in the following 12 months.
Death of a close person in the past 6 months.
Trial design
Treatments tested in this trial
- MDMA HCl
Treatment groups
168 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov