Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury.

NCT05732155 | Unknown Phase 2 DMC

• 1 other identifier: EMC 00077-21
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

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 .

Conditions

Post Traumatic Stress Disorder; Moral Injury; MDMA ('Ecstasy')

Outcome Measures

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.

  Maximum 46 weeks

Interventions

methylenedioxymethamphetamine DRUG

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 MDMA HCl, in participants with PTSD and moral injury, in individual and group treatment settings

Also known as: group therapy model

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Agree to the following lifestyle modifications : comply with requirements for fasting and refraining from certain medications prior to Experimental Sessions, not participate in any other interventional clinical trials during the duration of the study, remain overnight at the study site after each Experimental Session and be driven home after, and commit to medication dosing, therapy, and study procedures.
• At Screening, meet DSM-5 criteria for current PTSD with a symptom duration of 6 months or longer.
• At Screening, have at least moderate PTSD symptoms in the last month, based on PCL-5 total score of 36 or greater.
• May have well-controlled hypertension.
• May have asymptomatic Hepatitis C virus (HCV).
• May have alcohol or substance use disorder.
• May have a history of or current Diabetes Mellitus (Type 2).
• May have hypothyroidism if taking adequate and stable thyroid replacement medication.
• May have a history of, or current, glaucoma if approval for study participation is received from an ophthalmologist.

You may not qualify if:

• 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.
• Have received Electroconvulsive Therapy (ECT) within 12 weeks of enrollment.
• Have a history of or a current primary psychotic disorder.
• Have a current eating disorder with active purging assessed via MINI and clinical interview.
• Have current major depressive disorder with psychotic features assessed via MINI.
• Have a current alcohol or substance use disorder other than caffeine or nicotine that the investigators, therapy team, and/or study physician judge to be a safety concern for enrollment in the study.
• Have an active illicit (other than cannabis) or prescription drug substance use disorder at any severity within 12 months prior to enrollment.
• Have current Personality Disorders.
• Any participant presenting current serious suicide risk,
• Require ongoing concomitant therapy with a psychiatric medication with exceptions described in protocol section on Concomitant Medications.
• Have a history of any medical condition that could make receiving a sympathomimetic drug harmful because of increases in blood pressure and heart rate.
• Have uncontrolled essential hypertension using the standard criteria of the American Heart Association (values of 140/90 milligrams of Mercury \[mmHg\] or higher assessed on three separate occasions).

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• MAPS Public Benefit Corporation (MAPS PBC) 3141 Stevens Creek Blvd, #40547 San Jose, CA 95117 USA: collaborator

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

N-Methyl-3,4-methylenedioxyamphetamine

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Central Study Contacts

Guy Schusheim, Dr

CONTACT

972-4-6494138; guy_sc@clalit.org.il

Gilat ron avraham, Mph

CONTACT

972-4-6495590; gilat_av@clalit.org.il

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open-label study assesses the safety and preliminary effectiveness of MDMA-assisted therapy in participants diagnosed with PTSD. The study will be conducted in at least 30 participants. A flexible dose of MDMA HCl followed by a supplemental half dose unless tolerability issues emerge or a participant declines, is administered during the Treatment Period with manualized therapy in three open-label monthly Experimental Sessions (2 Experimental Individual Sessions, and one Experimental Group Session). This \~18-week Treatment Period is preceded by three Preparatory Sessions. Each Individual Experimental Session is followed by three Integrative Sessions of non-drug psychotherapy. The Group Experimental Session is preceded by 2 Preparatory Group Sessions and followed by 3 Group Integrative Sessions.

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: June 1, 2023
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 16, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share