Recruiting
Phase 2

MDMA-aCPT vs. CPT

Sponsor:

Patricia Suppes

Code:

NCT05837845

Conditions

PTSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MDMA

Cognitive Processing Therapy

MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)

Study Details

Brief 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

Study ID

NCT05837845

Start date

Feb 10, 2025

Status verified date

Jul, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MDMA-assisted Cognitive Processing Therapy (MDMA-aCPT)

This arm consists of 8-15 virtual CPT sessions (average of 12), one 90-minute, non-drug Preparatory Session, three Experimental Sessions with MDMA (\~8 hours), and three 90-minute, non-drug Integration Sessions, occurring over a 9-15-week Treatment Period. Standardized homework is assigned at each CPT session to promote the practice of the skills taught in the session. Participants will receive 80mg MDMA HCl for the first Experimental Session and will have the option of a supplemental dose of 40mg MDMA HCI 1.5-2 hours after the initial dose. For the second and third Experimental Sessions, participants will receive either 80mg or 120mg MDMA HCl as the initial dose, and an optional supplemental dose of 40mg or 60mg MDMA HCl 1.5-2 hours after the initial dose. Participants interested in receiving CPT treatment alone after study completion will have the option to be referred to their local VA PTSD Clinical Team for services 6 months after all study visits are completed.

experimental: Cognitive processing therapy

This arm consists of 8-15 virtual CPT treatment sessions lasting approximately 1-1.5 hours, occurring over a \~12-16-week Treatment Period. These sessions will take place approximately one week apart. Standardized homework is assigned at each session to promote the practice of the skills taught in the session. Participants will have the option to crossover to the MDMA-aCPT arm 6 months after all study visits are completed.

Interventions

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

Cognitive Processing Therapy

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

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.

Primary outcome measure

  • Change in Clinician Administered PTSD Scale (CAPS-5) Total Severity Score [ Time Frame: From Baseline to approximately 4 months post-baseline ]

Central Contacts and Locations

Central contacts

Anna Donnelly

650-849-0161exploratorytherapeuticslab@stanford.edu

Locations

VA Palo Alto Health Care System / Stanford University

Recruiting

Palo Alto, California, United States, 94304

Contacts

Anna Donnelly

650-849-0161anna.donnelly@va.gov

Principal Investigator:

Trisha Suppes, MD, PhD

More Information

Sponsor

Patricia Suppes

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • MDMA-assisted Therapy
  • Cognitive Processing Therapy
  • Veterans
  • Posttraumatic stress disorder
  • Quality of Life

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Patricia Suppes on 2025-07-31.