MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder

A Randomized Trial to Compare MDMA-assisted Cognitive Processing Therapy (aCPT) Versus a VA Standard-of-care CPT for the Treatment of Severe Posttraumatic Stress Disorder Among Veterans

MDMA-assisted Cognitive Processing Therapy Versus Cognitive Processing Therapy for Veterans With Severe Posttraumatic Stress Disorder (NCT05837845) is a Phase 2 interventional studying PTSD, sponsored by Patricia Suppes. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

In partnership with the Veterans Affairs (VA) Palo Alto Health Care System and Stanford University, this study aims to evaluate clinical outcomes, assess implementation feasibility, and health economics of MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT) in the treatment of posttraumatic stress disorder (PTSD). Through a randomized comparison of MDMA-aCPT versus Cognitive Processing Therapy (CPT), a VA gold standard treatment for PTSD, the proposed study will set the stage for understanding the potential use and application of MDMA-aCPT for PTSD within the VA system.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against PTSD and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 30 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Are at least 18 years at the time of signing the willing to sign a consent form 2. Are a U.S Military Veteran 3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System 4. Are fluent in speaking and reading in English 5. Agree to have study visits audio and/or video recorded 6. If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions 7. Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months 8. Have severe PTSD symptoms in the last month 9. Body weight of at least 48 kilograms (kg) 10. Is not pregnant, planning to get pregnant, or breastfeeding 11. Capable of giving signed willing to sign a consent form Who Should NOT Join This Trial: Participants are excluded from the study if any of the following criteria apply: 1. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful 2. Have current unstable medical illness 3. Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions 4. Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment 5. Moderate or severe alcohol or cannabis use disorder within the last 12 months 6. Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months 7. Have current serious suicide risk 8. Unable or unwilling to stop or safely taper off prohibited medications 9. Have used MDMA (ecstasy) ever 10. Currently enrolled in any clinical study ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: 1. Are at least 18 years at the time of signing the informed consent 2. Are a U.S Military Veteran 3. Are receiving services from VA Palo Alto Healthcare System, VA San Francisco Healthcare System, or VA NorCal Healthcare System 4. Are fluent in speaking and reading in English 5. Agree to have study visits audio and/or video recorded 6. If assigned to MDMA-aCPT, able to identify appropriate support person(s) to stay with the participant on the evenings of the MDMA sessions 7. Meet DSM-5 criteria for PTSD with a symptom duration of at least 6 months 8. Have severe PTSD symptoms in the last month 9. Body weight of at least 48 kilograms (kg) 10. Is not pregnant, planning to get pregnant, or breastfeeding 11. Capable of giving signed informed consent Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Have a history of any medical condition that could make receiving a sympathomimetic drug harmful 2. Have current unstable medical illness 3. Have cardiac conditions, including uncontrolled hypertension, prolonged QTc interval, and other cardiac conditions 4. Have received Electroconvulsive Therapy (ECT), ketamine-assisted therapy, or used ketamine within 12 weeks of enrollment 5. Moderate or severe alcohol or cannabis use disorder within the last 12 months 6. Active illicit drug (other than cannabis) or prescription drug substance use disorder at any severity within the last 12 months 7. Have current serious suicide risk 8. Unable or unwilling to stop or safely taper off prohibited medications 9. Have used MDMA (ecstasy) ever 10. Currently enrolled in any clinical study 11. Personal history of primary psychotic disorder, type I bipolar disorder, severe personality disorder, eating disorder with compensatory behaviors, or depressive disorder with psychotic features 12. Lack social support, or lack a stable living situation

Treatments Being Tested

DRUG

MDMA

Participants will receive a flexible divided-dose of MDMA HCl plus therapy at three Experimental Sessions, as well as non-drug Preparatory and Integration Sessions

BEHAVIORAL

Cognitive Processing Therapy

Participants will receive 8-15 (average of 12) sessions of Cognitive Processing Therapy

BEHAVIORAL

MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)

Participants assigned to MDMA-aCPT will undergo a therapeutic approach administered by trained therapists. MDMA seems to engender internal awareness that even painful feelings that arise are an important part of the therapeutic process. MDMA can elicit feelings of empathy, love, and deep appreciation, along with a clearer perspective of the trauma as a past event, a more accurate perspective about its significance, and a heightened awareness of the support and safety that exists in the present. A combined treatment of MDMA and therapy may be especially useful for treating PTSD because MDMA can attenuate the fear response of a perceived threat to one's emotional integrity and decrease defensiveness without blocking access to memories or preventing a deep and genuine experience of emotion.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

VA Palo Alto Health Care System / Stanford University

Palo Alto, California, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT05837845), the sponsor (Patricia Suppes), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT05837845 clinical trial studying?

Who can participate in NCT05837845?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT05837845?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT05837845. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT05837845. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.