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

Post Traumatic Stress Disorder Clinical Trial

Official title: Preliminary Effectiveness of Individual and Group MDMA-assisted Therapy for Israeli Veterans With PTSD and Moral Injury From Special Forces Undercover Units

Status Not yet recruiting

Clinical Trial 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 .

Clinical Trial Description

This single-site, open-label study assesses the safety and preliminary effectiveness of MDMA-assisted therapy in participants diagnosed with PTSD. All therapy teams have been trained by MAPS PBC. 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. Experimental Sessions are followed by an overnight stay. The Primary Outcome measure, the change in PCL-5 from Baseline (Screening) will be repeated after each Experimental Session, with the final outcome assessed at ~35-weeks post Baseline (V18).

For each participant, the study will consist of:

• Screening Period: phone screen, informed consent, eligibility assessment, and Baseline assessments and enrollment of eligible participants

• Preparatory Period: medication tapering, Preparatory Sessions

• Treatment Period: three monthly Experimental Sessions and associated Integrative Sessions over ~17 weeks

• Follow-up Period and Study Termination: 1 week with no study visits, followed by Primary Outcome and Study Termination visit

After the Screening Period and Enrollment, eligible participants will begin a ~4-week Preparatory Period. Participants will attend three, 90-minute, non-drug, Preparatory Sessions (V1-3). Following the Preparatory Period, each participant will begin a ~17-week Treatment Period consisting of an Individual phase and a Group phase, with 2 Individual Experimental Sessions, and 1 Group Experimental Session. The Individual Experimental Sessions will each be followed by three Individual Integrative Sessions, and the Group Experimental Session will be followed by two Group Integrative Sessions. MDMA will be administered three times during the Treatment Period (V4, V8, and V14). The Experimental Sessions will last ~8 hours. Three 90-minute Individual Integration Sessions and a PCL-5 assessment (as an exploratory measure) will follow the first and second Individual Experimental Session (V4 and V8), each a week apart. The first Individual Integration Session (V5) will occur the morning following V4, and the next Individual Integration Session (V6) will occur a week later. The PCL-5 (V7) is administered a week after V6, at the third Integration Session (V7). The same regimen will follow Treatment 2 (V8): an Individual Integration Session (V9) will occur the morning following V8, the next Individual Integration Session (V11) a week later, PCL-5 assessment will take place at the same visit of the third Integration Session (V11) one week later. Finally, the Group treatment period will begin 2-10 weeks after V11. n order to synchronize between all individual participants, after their different dates completing V11, and to allow their joint synchronized commencement of the group phase. To reduce this time variability to a minimum, the Individual group members will commence their Individual treatment period within the same week as the rest of the group. Since the study team must recruit and screen potentially eligible participants (see Section 5.6 Recruitment Strategies), coordinate schedules among participating staff members, and coordinate medication taper plans and assessments there must be adequate flexibility factored into the timing of screening, initial enrollment, and scheduling. The timing of initial enrollment for participants may be delayed or adjusted at the sponsor-investigator's discretion. The group phase will begin with two 90-minute Preparatory Sessions (V12-V13), focused on enabling acquaintance among group members, and discussing the individual goals of each group member. Three Integration Sessions (V15-17), each a week apart, will follow the third Experimental Group Session (V14). V15 will take place the morning after V14. The Primary Outcome measure will be the change in PCL-5 Score from Screening (Baseline) to V18 (Outcome), ~7 weeks after the final Experimental Session (V14) and ~4 weeks after the final Integration Session (V17), and assessed by a rater from the research team. V18 will also be the study termination visit. ;

Related Conditions & MeSH terms

• Moral Injury
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Wounds and Injuries

• NCT number: NCT05732155
• Study type: Interventional
• Source: HaEmek Medical Center, Israel
• Contact: Guy Schusheim, Dr
• Phone: 972-4-6494138
• Email: guy_sc@clalit.org.il
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 1, 2023
• Completion date: December 1, 2024