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

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.

Conditions

• PTSD

Interventions

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.

Sponsors & Collaborators

• Stanford University

  collaborator OTHER

• VA Palo Alto Health Care System

  collaborator FED

• Steven & Alexandra Cohen Foundation

  collaborator OTHER

• Patricia Suppes

  lead OTHER

Principal Investigators

• Trisha Suppes, MD, PhD · VA Palo Alto Healthcare System / Stanford University

• Shannon Wiltsey Stirman, PhD · VA Palo Alto Healthcare System / Stanford University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-10

Primary Completion

2027-05-31

Completion

2027-12-31

FDA Drug

Yes

Countries

• United States

Study Locations