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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • MDMA HCl

    Drug

    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.

Treatment groups

168 Participants
are divided into 2 treatment groups
Group A: Group-based MDMA-assisted therapyExperimental treatment 1 intervention
Group B: Individual MDMA-assisted therapyExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in PTSD symptoms as measured by CAPS-5

Change from baseline in PTSD symptoms as measured by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5).

Time frame
Baseline to end-of-treatment visit (Week 17 in the GMAT; Week 13 in the IMAT)
2

Change in PTSD symptoms as measured by PCL-5

Change from baseline in PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5).

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

Secondary outcomes

1

Safety and tolerability

Severity, incidence and frequency of adverse events (AEs), treatment-emergent adverse events (TEAEs), adverse events of special interest (AESIs) and serious adverse events (SAEs).

Time frame
From baseline through end-of-study visit (Week 17 in the GMAT; Week 13 in the IMAT)
2

Suicidal ideation and behavior assessed with C-SSRS

Incidence of serious suicidal ideation and positive suicidal behavior assessed with the Columbia Suicide Severity Rating Scale (C-SSRS).

Time frame
From baseline through end-of-study visit Week 17 in the GMAT; Week 13 in the IMAT), assessed throughout the treatment period
3

Change in systolic and diastolic blood pressure

Mean change in systolic and diastolic blood pressure from pre-investigational product (IP) administration to the end of each Experimental Session.

Time frame
From pre-IP administration to end of each Experimental Session (Weeks 6, 10, and 14 in the GMAT arm; Weeks 4, 7, and 10 in the IMAT arm)
4

Change in heart rate

Mean change in heart rate from pre-investigational product (IP) administration to the end of each Experimental Session.

Time frame
From pre-IP administration to end of each Experimental Session (Weeks 6, 10, and 14 in the GMAT arm; Weeks 4, 7, and 10 in the IMAT arm)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sheba Medical Center

Lead sponsor

Source ClinicalTrials.gov
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