A Phase 2 interventional study of methylenedioxymethamphetamine in Post Traumatic Stress Disorder and MDMA ('Ecstasy'), sponsored by Guy Schusheim. Recruiting at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.
Sponsored by Guy Schusheim · Phase 2, Interventional, and Treatment
…and 6 more changes, on the record history on ClinicalTrials.gov ↗
Among 38 studies testing N-Methyl-3,4-methylenedioxyamphetamine in Stress Disorders, Post-Traumatic — 11 open to participants now, 12 under way, 1 of them phase 3. N-Methyl-3,4-methylenedioxyamphetamine · Stress Disorders, Post-Traumatic.
Among the 38 studies testing N-Methyl-3,4-methylenedioxyamphetamine in Stress Disorders, Post-Traumatic, this one is the 7th largest by planned enrollment, is one of 5 that started in 2023, is one of 28 in phase 2, reaches primary completion later than 5 of the 11 other live ones, and was the 25th registered.
2,682 studies on the registry are indexed under Stress Disorders, Post-Traumatic; 601 are open to participants now.
This study's planned enrollment of 60 is below the median of 69 across 2,196 interventional studies indexed under Stress Disorders, Post-Traumatic.
Browse Stress Disorders, Post-Traumatic studies →11 of the 38 studies testing N-Methyl-3,4-methylenedioxyamphetamine in Stress Disorders, Post-Traumatic are open now, in 3 countries. Each count lists the studies.
No approval found in the FDA or EMA files read. How studies give it is on its page →
Of the 417 Stress Disorders, Post-Traumatic studies recruiting now, 186 (45%) set no upper age limit and 205 (49%) stop at 75 or younger; 63 take children under 18; 89 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →38 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 5 started in 2023.
Median enrollment 25 across the 38 interventional studies. Of the 22 that completed or were terminated, 16 (73%) have results posted.
19 of 38 have an industry lead sponsor. The 10 most frequent:
This is the only study on the registry with Guy Schusheim as lead sponsor.
Guy Schusheim has 1 study filed under Stress Disorders, Post-Traumatic — fewer than ten, so there is no comparison to draw.
4 of the studies testing N-Methyl-3,4-methylenedioxyamphetamine in Stress Disorders, Post-Traumatic that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06117306Phase 3Healing BreakthroughMDMA-assisted Massed Prolonged Exposure for PTSD | 2027-03 |
| NCT07569159Sunstone MedicalMDMA Therapy in Veterans With PTSD | 2027-04-01 |
| NCT05837845Patricia SuppesMDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder | 2027-05 |
| NCT05732155Guy SchusheimPreliminary Effectiveness of Hybrid Individual and Group MDMA-assisted Therapy for War-related PTSD | 2027-06-01 |
Among the 38 studies testing N-Methyl-3,4-methylenedioxyamphetamine in Stress Disorders, Post-Traumatic, from their registry updates:
Nothing recorded among them since 2026-09-25.
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 war-related Post traumatic Stress Disorder, in a hybrid individual and group treatment protocol.
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 .
This is a single-site, two-arm, open-label, nonrandomized study evaluating the safety and preliminary effectiveness of MDMA-assisted therapy (MDMA-AT) in participants diagnosed with posttraumatic stress disorder (PTSD). The study will enroll at least 30 participants in the MDMA-AT arm. A treatment-as-usual (TAU) comparison arm of approximately 30 participants will be recruited separately. Therapy teams delivering MDMA-AT have been trained in the MAPS therapeutic approach.
The MDMA-AT intervention lasts approximately 18 weeks and includes an initial individual phase followed by a group phase. Participants receive three MDMA experimental sessions: two individual experimental sessions and one group experimental session. MDMA hydrochloride is administered during each experimental session, with a planned supplemental half-dose unless tolerability concerns arise or the participant declines. Experimental sessions last approximately 8 hours and are followed by an overnight stay.
Following screening, informed consent, eligibility assessment, baseline assessment, and enrollment, participants begin a preparatory period. This includes three 90-minute individual non-drug preparatory sessions (V1-V3), during which participants are prepared for the therapeutic process and experimental sessions. Medication tapering, when required, is completed according to the study protocol.
The individual treatment phase includes two individual MDMA experimental sessions (V4 and V8). Each experimental session is followed by three individual non-drug integration sessions. The first integration session takes place on the morning after the experimental session, with subsequent integration sessions occurring over the following weeks. Thus, V4 is followed by V5-V7, and V8 is followed by V9-V11. The PCL-5 is also administered during the treatment period as specified in the assessment schedule.
After completion of the individual phase, participants transition to the group phase. Because participants complete their individual treatment schedules on different dates, an interval is permitted before initiation of the group phase to allow members of each treatment group to begin group treatment together. To minimize variability in this interval, participants intended for the same group are scheduled to begin the individual treatment phase within approximately the same time period. Scheduling may nevertheless be adjusted because of recruitment, screening, staff availability, medication tapering, and other operational considerations.
The group phase begins with two non-drug group preparatory sessions (V12-V13), intended to introduce participants to the group format, facilitate acquaintance among group members, and discuss individual goals and expectations. Participants then complete one group MDMA experimental session (V14). During the main drug-effect period, participants engage primarily in inward-focused therapeutic work, with therapist support available as needed. The group experimental session is followed by three group integration sessions (V15-V17), with V15 occurring on the morning after V14 and subsequent sessions occurring over the following weeks.
The primary clinical outcome is change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) total score from baseline to the post-treatment assessment at V18. V18 also serves as the final study visit for the active treatment period. Additional CAPS-5 follow-up assessments are conducted at 3, 6, and 12 months following completion of the treatment protocol. Safety is monitored throughout treatment and follow-up according to study procedures.
The TAU comparison arm includes approximately 30 participants with PTSD receiving routine care through the psychiatric clinic of the Israeli Ministry of Defense at Emek Medical Center. Participants in this arm continue their usual psychiatric and psychotherapeutic care and do not receive MDMA as part of the study. Outcomes from this cohort will be used as an exploratory longitudinal comparator for the MDMA-AT cohort.
The criteria were revised on the registry on Oct 15, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive an approximately 18-week MDMA-assisted therapy intervention combining individual and group treatment. The intervention includes three individual preparatory sessions; two individual MDMA-assisted sessions, each followed by three individual integration sessions; two group preparatory sessions; one group MDMA-assisted session followed by three group integration sessions; and a final individual integration and termination session.
Drug: methylenedioxymethamphetamine
The nonrandomized treatment-as-usual (TAU) comparison cohort will comprise participants with war-related PTSD recruited concurrently from the same target population. Participants will receive no protocol-directed MDMA-assisted intervention and will continue any routine psychiatric, psychological, or other clinical care available to them outside the study. Eligibility criteria for the TAU cohort are less restrictive than those applied to the MDMA-assisted therapy arm. Study assessments will be conducted at baseline and approximately 3.5 months later, approximating the baseline-to-post-treatment interval in the MDMA-assisted therapy arm. Participants will receive US$500 for study participation.
Participants in the experimental arm receive MDMA hydrochloride during three approximately 8-hour experimental sessions conducted within a manualized MDMA-assisted therapy protocol. Two sessions are delivered individually and one is delivered in a group setting. Each session includes an initial dose of MDMA hydrochloride followed by a planned supplemental half-dose approximately two hours later, unless the participant declines or tolerability concerns arise. MDMA administration is embedded within preparatory and integration psychotherapy delivered according to the study protocol.
Also known as: MDMA
Change from pre-treatment baseline to post-treatment in CAPS-5 total score
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician-administered interview assessing PTSD symptom severity. The primary outcome is change in CAPS-5 total severity score from baseline to the post-treatment outcome assessment at V18. Higher CAPS-5 scores indicate greater PTSD symptom severity; therefore, a decrease from baseline indicates improvement. This outcome will be assessed in participants assigned to both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm.
Time frame: From baseline to V18, approximately 18 weeks
Change in CAPS-5 total score from baseline and from post-intervention to 3, 6, and 12 months follow-up assessments
The Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) is a clinician-administered interview assessing PTSD symptom severity. This secondary outcome evaluates change in CAPS-5 total severity score from the pre-treatment baseline assessment to the 3-, 6-, and 12-month follow-up assessments to evaluate the durability of treatment-related changes in PTSD symptoms. Higher CAPS-5 scores indicate greater PTSD symptom severity; therefore, a decrease from baseline indicates improvement. Follow-up assessments will be conducted only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline and 3, 6, and 12 months after completion of the treatment protocol.
Change in self-reported anxiety symptoms assessed with the Generalized Anxiety Disorder Scale (GAD-7)
Change in self-reported anxiety symptoms will be assessed using the seven-item Generalized Anxiety Disorder Scale (GAD-7). GAD-7 total scores range from 0 to 21, with higher scores indicating greater symptom severity. Participants in both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm will complete the measure at baseline and post-intervention. Participants in the experimental arm will additionally complete the measure after treatment sessions, except at V5, V9, and V15, which immediately follow the MDMA dosing sessions.
Time frame: Baseline and post-intervention in both study arms; additionally, before treatment sessions in the experimental arm throughout the approximately 18-week treatment period, except at V5, V9, and V15.
Change in self-reported depressive symptoms assessed with the Patient Health Questionnaire (PHQ-9)
Change in self-reported depressive symptoms will be assessed using the nine-item Patient Health Questionnaire (PHQ-9). Total scores range from 0 to 27, with higher scores indicating greater depressive symptom severity. Participants in both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm will complete the measure at baseline and post-intervention. Participants in the experimental arm will additionally complete the measure after treatment sessions, except at V5, V9, and V15, which immediately follow the MDMA dosing sessions.
Time frame: Baseline and post-intervention in both study arms; additionally, befor treatment sessions in the experimental arm throughout the approximately 18-week treatment period, except at V5, V9, and V15. The questionnaire assesses symptoms experienced during the
Change in exposure to morally injurious events assessed with the Moral Injury Events Scale (MIES) and moral injury-related psychosocial outcomes assessed with the Moral Injury Outcome Scale (MIOS)
Change in exposure to morally injurious events will be assessed using the nine-item Moral Injury Events Scale (MIES). The measure addresses transgressions committed by oneself or by others and experiences of betrayal during military service. Change in moral injury-related psychosocial outcomes will be assessed using the 14-item Moral Injury Outcome Scale (MIOS). The measure addresses guilt, shame, loss of trust, and self-condemnation following morally injurious experiences. Item scores are summed to produce a total score, with higher scores indicating greater exposure to morally injurious events. These outcome measures will be assessed in participants assigned to both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in general psychological distress and functioning assessed with the Outcome Questionnaire-45 (OQ-45)
Change in general psychological distress and functioning will be assessed using the 45-item Outcome Questionnaire (OQ-45). Each item is rated on a 5-point scale, and item scores are summed to produce a total score ranging from 0 to 180, in addition to subscale scores for symptom distress, interpersonal relations, and social role performance. Higher scores indicate greater distress and poorer functioning. Participants in both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm will complete the measure at baseline and post-intervention. Participants in the experimental arm will additionally complete the OQ-45 at the two individual MDMA dosing sessions, V4 and V8.
Time frame: Baseline and post-intervention in both study arms; additionally, at V4 and V8 in the experimental arm.
Change in functional impairment assessed with the Sheehan Disability Scale (SDS)
Change in functional impairment will be assessed using the three-item Sheehan Disability Scale (SDS). The measure addresses impairment in work or school, social life, and family life, each rated on a visual analogue scale from 0 to 10. Item scores are summed to produce a total score ranging from 0 to 30, with higher scores indicating greater functional impairment. This outcome will be assessed in participants assigned to both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm. Participants enrolled in cohorts 1-3 also completed the measure at V3 and V7.
Time frame: Baseline and post-intervention in both study arms; additionally, at V3 and V7 for participants enrolled in cohorts 1-3.
Change in trait aggression assessed with the Buss-Perry Aggression Questionnaire (BPAQ)
Change in trait aggression will be assessed using the 29-item Buss-Perry Aggression Questionnaire (BPAQ). The measure addresses physical aggression, verbal aggression, anger, and hostility. Item scores are summed to produce a total score, with higher scores indicating greater trait aggression. This outcome will be assessed in participants assigned to both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm.
Time frame: This measure will be assessed at baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in social connectedness assessed with the Social Connectedness Scale (SCS)
Change in subjective social connectedness will be assessed using the Social Connectedness Scale (SCS). The measure addresses an individual's sense of belonging and connectedness to other people and to society. Item scores are summed to produce a total score, with higher scores indicating greater social connectedness. Participants in both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm will complete the measure at baseline and post-intervention. Participants in the experimental arm will additionally complete the measure at V3, V7, and V11.
Time frame: Baseline and post-intervention in both study arms; additionally, at V3, V7, and V11 in the experimental arm.
Change in experiential avoidance assessed with the Brief Experiential Avoidance Questionnaire (BEAQ)
Change in experiential avoidance will be assessed using the 15-item Brief Experiential Avoidance Questionnaire (BEAQ). The measure addresses the tendency to avoid unwanted internal experiences such as distressing thoughts, feelings, memories, and bodily sensations. Item scores are summed to produce a total score ranging from 15 to 90, with higher scores indicating greater experiential avoidance. Participants in both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm will complete the measure at baseline and post-intervention. Participants in the experimental arm will additionally complete the measure at V3, V7, and V11.
Time frame: Baseline and post-intervention in both study arms; additionally, at V3, V7, and V11 in the experimental arm.
Outcome Rating Scale (ORS) - general well-being and functioning during the preceding week
The Outcome Rating Scale (ORS) is a four-item participant-reported measure designed to assess general well-being and functioning during the preceding week. The instrument evaluates four domains: individual well-being, interpersonal relationships, social functioning, and overall well-being. Items are rated using visual analogue scales and summed to produce a total score ranging from 0 to 40, with higher scores indicating better perceived well-being and functioning. Participants in both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm will complete the measure at baseline and post-intervention. Participants in the experimental arm will additionally complete the measure after each treatment session.
Time frame: Baseline and post-intervention in both study arms; additionally, after each treatment session in the experimental arm throughout the approximately 18-week treatment period.
Two-item Working Alliance Inventory (WAI) - post-session process measure in the MDMA-AT arm
The Working Alliance Inventory (WAI) is a self-report measure assessing the quality of the therapeutic alliance. This post-session measure will be assessed using two items from the WAI in the MDMA-assisted therapy arm.
Time frame: Once weekly, at the end of each session, throughout the approximately 18-week treatment period.
Emotional Breakthrough Inventory (EBI) - post-session process measure in the MDMA-AT arm
The Emotional Breakthrough Inventory (EBI) is a participant-reported measure assessing the extent to which an individual experienced emotional release, insight, or resolution of difficult emotional material during an intervention. An abbreviated three-item version (EBI-3) will be used following non-MDMA treatment sessions. At the MDMA dosing sessions, participants will complete the full six-item EBI. Higher aggregate scores indicate a greater perceived degree of emotional breakthrough. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: At the end of treatment sessions throughout the approximately 18-week treatment period; the six-item EBI will be administered at the MDMA dosing sessions (V4, V8, and V14), and the three-item version will be administered following non-MDMA sessions.
Participant-Rated Session Evaluation (SES-5) - post-session process measure in the MDMA-AT arm
The SES-5 is a five-item self-report measure assessing participants' subjective evaluation of their therapeutic experience, including its perceived quality, helpfulness, and overall impact. A total score will be calculated according to the instrument's scoring instructions, with higher scores indicating a more positive evaluation of the therapeutic experience. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Once weekly, following non-MDMA treatment sessions throughout the approximately 18-week treatment period. The measure will not be administered at the MDMA dosing sessions (V4, V8, and V14).
Session Rating Scale (SRS-4) - post-session measure in the MDMA-AT arm
The Session Rating Scale-4 (SRS-4) is a four-item self-report measure assessing participants' perceptions of the therapeutic alliance and treatment session. The measure addresses the therapeutic relationship, agreement concerning treatment goals and topics, agreement concerning the therapeutic approach and methods, and the participant's overall evaluation of the session. Each item is rated on a visual analogue scale, and the four item scores are summed to produce a total score ranging from 0 to 40. Higher scores indicate a stronger perceived therapeutic alliance and a more positive evaluation of the therapeutic session. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Once weekly, following non-MDMA treatment sessions throughout the approximately 18-week treatment period. The measure will not be administered at the MDMA dosing sessions (V4, V8, and V14).
Group communitas assessed with the Adapted Psychedelic Communitas Scale (COMS)
Group communitas will be assessed using an adapted version of the Psychedelic Communitas Scale (COMS), a 10-item self-report measure. The measure addresses acute experiences of togetherness and shared humanity within a group. A total score will be calculated according to the instrument's scoring instructions, with higher scores indicating a stronger sense of communitas. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Once, at V15, in the experimental arm.
Group therapeutic factors assessed with the Therapeutic Factors Inventory-Short Form (TFI-S)
Group therapeutic factors will be assessed using the eight-item Therapeutic Factors Inventory-Short Form (TFI-S). The measure addresses group therapeutic processes such as cohesion and catharsis. A total score will be calculated according to the instrument's scoring instructions, with higher scores indicating stronger endorsement of these therapeutic factors. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Following group treatment sessions, except V14. The measure will not be assessed at baseline or post-intervention.
Identity fusion with the treatment group assessed with the Identity Fusion Scale (IFS)
Identity fusion with the treatment group will be assessed using the Identity Fusion Scale (IFS), a brief self-report and pictorial measure. The measure addresses the degree to which participants experience a shared identity with their treatment group. A score will be calculated according to the instrument's scoring instructions, with higher scores indicating stronger identity fusion. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Following group treatment sessions, except V14. The measure will not be assessed at baseline or post-intervention.
Change in trait anxiety assessed with the State-Trait Anxiety Inventory-Trait Subscale (STAI-T)
Change in trait anxiety will be assessed using the 20-item Trait subscale of the State-Trait Anxiety Inventory (STAI-T). Each item is rated on a 4-point scale, and item scores are summed to produce a total score ranging from 20 to 80, with higher scores indicating greater trait anxiety. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: This measure will be assessed at baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in state anxiety assessed with the State-Trait Anxiety Inventory-State Subscale (STAI-S)
Change in state anxiety will be assessed using the 20-item State subscale of the State-Trait Anxiety Inventory (STAI-S). Each item is rated on a 4-point scale, and item scores are summed to produce a total score ranging from 20 to 80, with higher scores indicating greater state anxiety. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in interoceptive awareness assessed with the Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2)
Change in interoceptive awareness will be assessed using the 37-item Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). The measure yields eight subscale scores: Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-Regulation, Body Listening, and Trusting. Each is rated on a 6-point scale, with higher subscale scores indicating greater interoceptive awareness in that domain. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in Perceived Stress Assessed With the Perceived Stress Scale (PSS)
Change in perceived stress will be assessed using the 10-item Perceived Stress Scale (PSS). Each item is rated on a 5-point scale, and item scores are summed to produce a total score ranging from 0 to 40, with higher scores indicating greater perceived stress. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in difficulties in emotion regulation assessed with the Difficulties in Emotion Regulation Scale (DERS)
Change in difficulties with emotion regulation will be assessed using the 36-item Difficulties in Emotion Regulation Scale (DERS). The measure yields a total score reflecting nonacceptance of emotional responses, difficulty engaging in goal-directed behavior, impulse-control difficulties, lack of emotional awareness, limited access to emotion regulation strategies, and lack of emotional clarity. Item scores are summed to produce a total score ranging from 36 to 180, with higher scores indicating greater difficulties in emotion regulation. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in adult attachment orientation assessed with the Experiences in Close Relationships-Short Form (ECR-S)
Change in adult attachment orientation will be assessed using the 12-item Experiences in Close Relationships-Short Form (ECR-S). The measure yields two subscale scores, attachment-related anxiety and attachment-related avoidance, with higher scores on either subscale indicating greater attachment insecurity. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in depressive symptom severity assessed with the Beck Depression Inventory-II (BDI-II)
Change in depressive symptom severity will be assessed using the 21-item Beck Depression Inventory-II (BDI-II). Each item is rated on a 4-point scale, and item scores are summed to produce a total score ranging from 0 to 63, with higher scores indicating greater depressive symptom severity. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Change in psychosocial functional impairment assessed with the Brief Inventory of Psychosocial Functioning (B-IPF)
Change in psychosocial functional impairment will be assessed using the seven-item Brief Inventory of Psychosocial Functioning (B-IPF). The measure assesses impairment during the preceding 30 days across seven domains of psychosocial functioning: romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care. A total score will be calculated according to the instrument's scoring instructions, with higher scores indicating greater functional impairment. This outcome will be assessed in participants assigned to both the experimental MDMA-assisted therapy arm and the treatment-as-usual arm.
Time frame: Baseline (pre-intervention) and following completion of the intervention (post-intervention).
Self-kindness assessed with a two-item measure adapted from the Self-Compassion Scale (SCS)
Self-kindness will be assessed using two items adapted from the Self-Kindness subscale of the Self-Compassion Scale (SCS). The items assess tolerance toward one's own flaws and an understanding, kind attitude toward oneself. The two item scores will be combined, with higher scores indicating greater self-kindness. This outcome will be assessed only in participants assigned to the experimental MDMA-assisted therapy arm.
Time frame: At the MDMA dosing sessions (V4, V8, and V14) in the experimental arm.
Plan to share: No — Participants will be assigned a unique identifier by the sponsor-investigator. Any participant records or datasets that are transferred will contain the identifier only; participant names or any information which would make the participant identifiable will not be transferred.
No publications or documents are linked to this record.
Started Jun 2023 (actual). Primary completion is estimated for Jun 2027, 48 months after the start.
Of 87 non-industry phase 2 interventional studies under Stress Disorders, Post-Traumatic, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 35 and three quarters within 59. This study's planned 48 months is close to that.
Counting every sponsor, half of 118 studies reached it within 38 months; a quarter within 23 and three quarters within 53.
Completion moved once since we started tracking on Sep 25, 2026: Dec 2028 → Jul 2028, on Oct 15, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
…and 6 more changes, on the record history on ClinicalTrials.gov ↗
…and 6 more changes, on the record history on ClinicalTrials.gov ↗
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: N-Methyl-3,4-methylenedioxyamphetamine
Stress Disorders, Post-Traumatic →