Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury.
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHaEmek Medical Center, Israel
About this trial
The overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of methylenedioxymethamphetaminel, in participants with Post traumatic Stress Disorder and moral injury, in individual and group treatment settings.
The overall safety objective is to assess the severity, incidence, and frequency of AEs, AEs of Special Interest (AESIs), and Serious Adverse Events (SAEs), concomitant medication use, suicidal ideation and behavior and vital signs .
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Are veterans of special forces undercover units in the Israeli army.
Are fluent in speaking and reading the predominantly used or recognized language of the study site (Hebrew).
Are able to swallow pills.
Agree to have study visits recorded, including Experimental Sessions, and non-drug psychotherapy sessions.
Disqualifiers
Are not able to give adequate informed consent.
Have used Ecstasy (material represented as containing MDMA) more than 10 times within the last 10 years or at least once within 6 months of the first Experimental Session; or have previously participated in a MAPS-sponsored MDMA clinical trial.
Have any current problem which, in the opinion of the investigator or study physician, might interfere with participation.
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the sponsor-investigator or study clinician, contraindicates participation in the study.
Trial design
Design model
Single group
Treatments tested in this trial
methylenedioxymethamphetamine
DrugThe overall objective of this study is to use standard clinical measures to explore the safety and preliminary effectiveness of open-label MDMA-assisted therapy with a flexible dose of MDMA HCl, in participants with PTSD and moral injury, in individual and group treatment settings
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
the change in PCL-5 (PTSD Checklist for DSM-5 ) from Baseline
The primary endpoint is the change in mean PCL-5 Scores from Baseline (T1, Screening) to Primary Outcome Visit (T5, V18). Analysis of the primary endpoint will be conducted using an ANCOVA model, comparing PCL-5 scores at baseline and at primary endpoint, while adjusting for baseline PCL-5 and potential covariates. The primary endpoint analyses will be based on the mITT analysis set plus DSP4. Adjustment for additional potential covariates and subgroups will be explored. Additional details will be provided in the SAP.
Time frame
Maximum 46 weeksSponsors and contacts
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HaEmek Medical Center, Israel
Lead sponsor
MAPS Public Benefit Corporation (MAPS PBC) 3141 Stevens Creek Blvd, #40547 San Jose, CA 95117 USA
Collaborator
Source ClinicalTrials.gov