RecruitingPhase 2NCT05837845

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


Sponsor

Patricia Suppes

Enrollment

30 participants

Start Date

Feb 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two treatments for veterans with severe PTSD (post-traumatic stress disorder): standard Cognitive Processing Therapy (CPT) versus MDMA-assisted Cognitive Processing Therapy — where a controlled, supervised dose of MDMA (the active compound in ecstasy) is combined with the therapy. The goal is to see whether MDMA can help make trauma therapy more effective for those with the most severe PTSD. **You may be eligible if...** - You are a U.S. Military Veteran aged 18 or older - You receive care at one of three VA healthcare systems in the Bay Area / NorCal - You have been diagnosed with PTSD for at least 6 months with severe current symptoms - You weigh at least 48 kg (about 106 lbs) - You are not pregnant and not planning to become pregnant - You can identify a support person to stay with you after MDMA sessions **You may NOT be eligible if...** - You have heart conditions, uncontrolled hypertension, or certain other medical conditions that make stimulant drugs dangerous - You have a history of psychosis, bipolar I disorder, or severe personality or eating disorders - You have ever used MDMA (ecstasy) before - You have moderate or severe alcohol or drug use disorder in the past year - You have had ECT or ketamine therapy in the past 12 weeks Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMDMA

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

BEHAVIORALCognitive Processing Therapy

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

BEHAVIORALMDMA-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)

VA Palo Alto Health Care System / Stanford University

Palo Alto, California, United States

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NCT05837845


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